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</span><a class="mr-1 text-author hover:text-primary" href="/authors/michael-w-dong">Michael W. Dong</a></span><span class="text-md "><span class=""><br/></span><a class="mr-1 text-author hover:text-primary" href="/authors/kim-huynh-ba">Kim Huynh-Ba</a></span><span id="more" class="hidden"><ul><li><a class="mr-1 text-author hover:text-primary" href="/authors/joshua-t.-ayers">Joshua T. Ayers</a></li></ul></span><br/><button id="button" class="mt-2 p-1 rounded text-sm text-primary duration-300 flex justify-center items-center">View All<span class="ml-1"><svg stroke="currentColor" fill="currentColor" stroke-width="0" viewBox="0 0 512 512" height="1em" width="1em" xmlns="http://www.w3.org/2000/svg"><path d="M256 294.1L383 167c9.4-9.4 24.6-9.4 33.9 0s9.3 24.6 0 34L273 345c-9.1 9.1-23.7 9.3-33.1.7L95 201.1c-4.7-4.7-7-10.9-7-17s2.3-12.3 7-17c9.4-9.4 24.6-9.4 33.9 0l127.1 127z"></path></svg></span></button></div></div><div class="flex flex-wrap sm:flex-nowrap items-center w-fit "><div class="flex items-center w-fit h-[22px] mr-4 px-2 bg-primary text-white text-xs"><em>Publication</em></div><div class="flex items-center w-fit h-[22px] mr-4 px-2 bg-primary text-white text-xs"><em>Article</em></div></div><div class="flex my-1 flex-col"><span class="text-sm font-bold">LCGC North America</span><span class="text-sm">LCGC North America-08-01-2020</span><div class="flex"> <div class="text-sm mr-4">Volume <span class="font-bold">38</span></div><div class="text-sm">Issue <span class="font-bold">8</span></div></div></div><div class="text-sm">Pages: 440–456</div><div class="mt-4"><div class="mt-2 flex items-center max-w-fit"><button title="Development of Stability-Indicating Analytical Procedures by HPLC: An Overview and Best Practices" aria-label="facebook" class="react-share__ShareButton" style="background-color:transparent;border:none;padding:0;font:inherit;color:inherit;cursor:pointer"><svg viewBox="0 0 64 64" width="32" height="32"><circle cx="32" cy="32" r="31" fill="#3b5998"></circle><path d="M34.1,47V33.3h4.6l0.7-5.3h-5.3v-3.4c0-1.5,0.4-2.6,2.6-2.6l2.8,0v-4.8c-0.5-0.1-2.2-0.2-4.1-0.2 c-4.1,0-6.9,2.5-6.9,7V28H24v5.3h4.6V47H34.1z" fill="white"></path></svg></button><button aria-label="twitter" class="react-share__ShareButton" style="background-color:transparent;border:none;padding:0;font:inherit;color:inherit;cursor:pointer"><svg fill="#DC7633" 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md:text-center my-2 md:my-0 p-0 sm:px-4"><a class="" href="/columns/column-perspectives-modern-hplc"><div class="relative max-w-[300px]"><span style="box-sizing:border-box;display:inline-block;overflow:hidden;width:initial;height:initial;background:none;opacity:1;border:0;margin:0;padding:0;position:relative;max-width:100%"><span style="box-sizing:border-box;display:block;width:initial;height:initial;background:none;opacity:1;border:0;margin:0;padding:0;max-width:100%"><img style="display:block;max-width:100%;width:initial;height:initial;background:none;opacity:1;border:0;margin:0;padding:0" alt="" aria-hidden="true" src="data:image/svg+xml,%3csvg%20xmlns=%27http://www.w3.org/2000/svg%27%20version=%271.1%27%20width=%2748.66412213740458%27%20height=%2751%27/%3e"/></span><img src="data:image/gif;base64,R0lGODlhAQABAIAAAAAAAP///yH5BAEAAAAALAAAAAABAAEAAAIBRAA7" decoding="async" data-nimg="intrinsic" class="shrink-0" style="position:absolute;top:0;left:0;bottom:0;right:0;box-sizing:border-box;padding:0;border:none;margin:auto;display:block;width:0;height:0;min-width:100%;max-width:100%;min-height:100%;max-height:100%"/><noscript><img srcSet="/_next/image?url=https%3A%2F%2Fcdn.sanity.io%2Fimages%2F0vv8moc6%2Fchroma%2F81cf69ed6f838d47000f016797c0ed0620f71503-250x262.png%3Ffit%3Dcrop%26auto%3Dformat&w=64&q=75 1x, /_next/image?url=https%3A%2F%2Fcdn.sanity.io%2Fimages%2F0vv8moc6%2Fchroma%2F81cf69ed6f838d47000f016797c0ed0620f71503-250x262.png%3Ffit%3Dcrop%26auto%3Dformat&w=128&q=75 2x" src="/_next/image?url=https%3A%2F%2Fcdn.sanity.io%2Fimages%2F0vv8moc6%2Fchroma%2F81cf69ed6f838d47000f016797c0ed0620f71503-250x262.png%3Ffit%3Dcrop%26auto%3Dformat&w=128&q=75" decoding="async" data-nimg="intrinsic" style="position:absolute;top:0;left:0;bottom:0;right:0;box-sizing:border-box;padding:0;border:none;margin:auto;display:block;width:0;height:0;min-width:100%;max-width:100%;min-height:100%;max-height:100%" class="shrink-0" loading="lazy"/></noscript></span></div></a></div></div></div><p class="py-2 mb-2 text-sm italic text-gray-600">Here we provide an overview of the fundamentals and best practices on the development of stability-indicating HPLC methods for drug substances and products. We explain both traditional and easier modern approaches to developing stability-indicating HPLC methods—including using a universal generic method for new chemical entities—and address regulatory considerations and life cycle management strategies.</p><div class="py-2"><div class="blockText_blockContent__TbCXh"><p class="pb-2"><strong>This installment is the second in a series of three white papers on stability studies and testing of pharmaceuticals. It focuses on the development of stability-indicating high performance liquid chromatography (HPLC) methods for drug substances and products. This paper provides an overview of the fundamentals and best practices in method development, including the traditional and other easier approaches, as well as modern trends and software tools for expediting the process. The regulatory guidance on the necessary contents of a well-written method, strategies for efficient method execution, and life cycle management of analytical procedures, are described.</strong></p><p class="pb-2">High performance liquid chromatography (HPLC) method development can be a time-consuming process, particularly for stability-indicating analytical procedures of new chemical entities (NCEs). Most of the procedures for small-molecule drugs employ gradient reversed-phase liquid chromatography (RPLC) with ultraviolet (UV) detection. These methods are designed to separate and quantitate the active pharmaceutical ingredients (APIs) and all process impurities and degradation products in drug substance (DS) and drug product (DP) samples. This important HPLC method category provides quality assessment data required in product release and stability studies in regulatory filings and procedures (Table I). Information on the HPLC method development process and requirements are available in many textbooks (1–6), journal articles (7–13), regulatory guidance documents (14–16), and other resources (17). In this installment, we strive to provide a concise but comprehensive overview of the essential steps of the method development process, supported with case studies, common practices, regulatory guidance, and citations of critical references.</p><p class="pb-2"></p><div class="flex justify-center"><div style="width:30%;float:;max-width:525px;margin:0 auto 1rem;clear:both;cursor:pointer" class=" figure"><div class="flex-none relative text-center"><span style="box-sizing:border-box;display:inline-block;overflow:hidden;width:initial;height:initial;background:none;opacity:1;border:0;margin:0;padding:0;position:relative;max-width:100%"><span style="box-sizing:border-box;display:block;width:initial;height:initial;background:none;opacity:1;border:0;margin:0;padding:0;max-width:100%"><img style="display:block;max-width:100%;width:initial;height:initial;background:none;opacity:1;border:0;margin:0;padding:0" alt="" aria-hidden="true" src="data:image/svg+xml,%3csvg%20xmlns=%27http://www.w3.org/2000/svg%27%20version=%271.1%27%20width=%27630%27%20height=%27737%27/%3e"/></span><img alt="" title="" src="data:image/gif;base64,R0lGODlhAQABAIAAAAAAAP///yH5BAEAAAAALAAAAAABAAEAAAIBRAA7" decoding="async" data-nimg="intrinsic" style="position:absolute;top:0;left:0;bottom:0;right:0;box-sizing:border-box;padding:0;border:none;margin:auto;display:block;width:0;height:0;min-width:100%;max-width:100%;min-height:100%;max-height:100%;object-fit:contain"/><noscript><img alt="" title="" srcSet="/_next/image?url=https%3A%2F%2Fcdn.sanity.io%2Fimages%2F0vv8moc6%2Fchroma%2F631870c2ecf2aef2c70a58d47b5309b9c1905e66-630x737.jpg%3Ffit%3Dcrop%26auto%3Dformat&w=640&q=75 1x, /_next/image?url=https%3A%2F%2Fcdn.sanity.io%2Fimages%2F0vv8moc6%2Fchroma%2F631870c2ecf2aef2c70a58d47b5309b9c1905e66-630x737.jpg%3Ffit%3Dcrop%26auto%3Dformat&w=1920&q=75 2x" src="/_next/image?url=https%3A%2F%2Fcdn.sanity.io%2Fimages%2F0vv8moc6%2Fchroma%2F631870c2ecf2aef2c70a58d47b5309b9c1905e66-630x737.jpg%3Ffit%3Dcrop%26auto%3Dformat&w=1920&q=75" decoding="async" data-nimg="intrinsic" style="position:absolute;top:0;left:0;bottom:0;right:0;box-sizing:border-box;padding:0;border:none;margin:auto;display:block;width:0;height:0;min-width:100%;max-width:100%;min-height:100%;max-height:100%;object-fit:contain" loading="lazy"/></noscript></span></div><div class="top-[-100%] block w-[1px] transition-opacity duration-500 ease-in-out opacity-0 overflow-hidden"><img class="m-auto absolute inset-0 max-w-[0%] max-h-[0%] border-[3px] border-solid border-white shadow-[0px_0px_8px_rgba(0,0,0,0.3)] box-border transition ease-in-out duration-500" src="https://cdn.sanity.io/images/0vv8moc6/chroma/631870c2ecf2aef2c70a58d47b5309b9c1905e66-630x737.jpg?fit=crop&auto=format"/></div></div><style> #image-caption p{ font-size: 12px; max-width: 525px; margin: 0 auto; text-align: center; } </style></div><p class="pb-2"><strong>Why Gradient RPLC with UV Detection for Stability-Indicating Methods?</strong></p><p class="pb-2">Let us start with the fundamentals and the rationale for the use of RPLC and UV methods in stability-indicating analytical procedures, which must separate the API from all impurities, and meet stringent regulatory requirements in method performance (6,14–16).</p><p class="pb-2">First, the primary retention mechanism in RPLC is hydrophobic interaction, particularly useful for compounds with intermediate polarities, and an excellent match of most small-molecule drugs with oral bioavailability (2). The weak dispersive forces in RPLC ensure that all components in the sample can be eluted from the column using strong purging solvents at the end of the gradient, thus yielding 100% recovery of the injected sample.</p><p class="pb-2">Second, the elution order in RPLC is highly predictable. It follows the “Linear Solvent Strength Model (4).” In most cases, the log <em>k</em> (retention factor) of the analyte is inversely proportional to %MPB (mobile phase B or % of the strong organic modifier). In addition, most drugs are basic, but have sufficient hydrophobicity to be retained in RPLC in the ionized forms in acidic mobile phases. The retention of the “solvated” analytes can be manipulated to provide increased resolution by changing the composition of the mobile phase (for example, water, organic solvents, and pH), that interacts with the analytes in the “solvated” state, and moderates their retention on the stationary phase (1,2). Gradient elution is commonly used in stability-indicating assays to yield higher peak capacity and sensitivity for both hydrophilic and hydrophobic components in the sample (2).</p><p class="pb-2">Third, most NCEs are chromophoric, having one or more conjugated double bonds or aromatic moieties in their structures, thus providing high detection sensitivity with UV detectors. A peak area precision of 0.1–0.5% relative standard deviation (RSD) is routinely achievable in HPLC-UV assays, because the entire injected sample passes through the UV flow cell. This high precision performance is necessary for quality control applications for DS release testing (with typical specifications of 98.0–102.0%). In contrast, the precision performance of <1% is difficult to achieve with mass spectrometry (MS) detection, because only a small fraction of the nebulized eluent stream is ionized and detected (2). Furthermore, a UV detector offers a wide linear response range exceeding five orders of magnitude (1 x 10-5 to ~2 absorbance units [AU]), allowing the use of a single-point calibration curve for early-phase assays, and normalized area % analysis for the determination of impurities (2).</p><p class="pb-2">There are some notable exceptions to the adoption of RPLC-UV methods. For NCEs with no or low chromophoric properties, a gradient-compatible near-universal detector, such as a charged aerosol detector (CAD) or an evaporative light-scattering detector (ELSD), is typically employed (2). For the determination of enantiomers, a normal-phase separation using chiral LC or supercritical fluid chromatography (SFC) separation, is generally preferred, because the analytes are present in an unassociated and non-ionized state, which often leads to higher selectivity differences between the enantiomers (2).</p><p class="pb-2">Another exception is the determination of potentially genotoxic impurities at parts-per-million levels (not discussed here), which may require a high-sensitivity analytical procedure, such as<br/>LC with mass spectrometry detection (LC–MS) (2).</p><p class="pb-2"></p><p class="pb-2"><strong>Objectives of This Article</strong></p><p class="pb-2">The objectives of this installment are as follows.</p><p class="pb-2">Describe the traditional five-step strategy in HPLC method development, according to Snyder and associates (1), and illustrate the use of the selectivity-tuning for method optimization with case studies.</p><p class="pb-2">Describe modern HPLC method development trends using ultrahigh-pressure liquid chromatography (UHPLC), MS, automated column or mobile-phase screening systems, and software platform tools.</p><p class="pb-2">Introduce easier or more straight-forward method development approaches, including a three-pronged template for early-phase development and universal generic gradient methods.</p><p class="pb-2">Describe the essential elements of a well-written analytical method, strategies for effective method execution,and the concept of life cycle management of analytical procedures.</p><p class="pb-2"><strong>The Traditional Five-Step Method Development Approach</strong></p><p class="pb-2">A traditional five-step approach for HPLC method development was proposed by Snyder and associates, based on the concept of selectivity-tuning to increase the resolution of critical pairs (close-eluting peaks) for accurate quantitation (1,2). The five-step approach is outlined here.</p><p class="pb-2"></p><p class="pb-2"><strong>Step 1: Defining Method Types</strong></p><p class="pb-2">The first step is to define the method type. Is it a preparative, qualitative, or quantitative method? The most common method type is a stability-indicating analytical procedure (also known as an <em>assay and impurities determination</em>) for the quantitation of the API and impurities in pharmaceuticals. It is a challenging method development task to develop this type of method, because all key components in the sample must be physically separated in one chromatogram with method performance compliant to ICH guidelines (14). In comparison, other pharmaceutical methods for identification, limit tests, or performance assays, are simpler to develop, validate, and execute. Typically, the DS method is developed first for the NCE, and the DP method is then optimized based on the DS method.</p><p class="pb-2"></p><p class="pb-2"><strong>Step 2: Gathering Sample and Analyte Information</strong></p><p class="pb-2">The next step is to gather information on the sample and analytes. For NCEs, the structures and molecular formulae are well established, allowing the inference or calculation of physicochemical properties, such as <em>pK</em>a, log<em>P</em>, log<em>D</em>, polarity, numbers of acidic, basic, or aromatic functional groups, and chiral centers. These characteristics can be useful in the selection of columns, mobile phases, and sample diluents. The <em>pK</em>a values can be used to select a mobile- phase pH that ensures the compound is in a singly charged state. Knowledge of the acidic, basic, and aromatic functional groups can be helpful in column and mobile-phase selection, and provides forewarnings of potential stability or reactivity issues. Finally, knowing the presence and number of chiral centers is vital for planning an analytical procedure that includes diastereomeric separations. Though not entirely in the scope of this article, possible diastereomeric combinations may be separated with an achiral RPLC column (shown in the case study in Figure 5). Enantiomeric separation offers a different challenge that will require selecting the appropriate chiral-selective column for the determination of enantiomers of the API using a different analytical procedure. To gather analyte information, resources such as Certificate of Analysis (CoA) from suppliers or technical packages from the API manufacturers are invaluable in obtaining initial information regarding sample purity, methodologies, spectral and safety data, and other attributes of the API.</p><p class="pb-2"></p><p class="pb-2"><strong>Step 3: Initial Method Development</strong></p><p class="pb-2">This is the first laboratory-based step in the development process, and it involves performing “scouting” runs to obtain the first chromatograms. Details in column and mobile-phase selection are covered in many books (1–3). To illustrate the initial method development step, we will start here with the most common choice of a C18 column used with an acidified aqueous mobile phase and organic solvent. Step #3, outlined here, is extracted from a case study published in this reference (2).</p><p class="pb-2">Here, a sample of the API is dissolved in a default diluent (in this case, 1 mg/mL in 50% acetonitrile in water) and injected into an HPLC-UV system (with a photodiode array (PDA) detector and an MS instrument. A common broad-gradient RPLC method can be used (such as mobile phase A [MPA] = 0.1% formic acid in water; mobile phase B [MPB] = acetonitrile; C18 column: 3-µm, 100 mm x 3.0 mm i.d., 5–100% acetonitrile in 10 min at 1 mL/min and a column temperature at 30 oC). Full spectral data in UV (220–400 nm) and MS (100–1200 amu with positive ionization) are collected to allow reconstruction of chromatograms at any monitoring wavelengths.</p><p class="pb-2">It is important to choose an MS-friendly mobile phase in this step if possible, to reduce the need for any method changes when using MS later. Results from the first scouting run can generate pertinent data, such as a “rough” sample impurity profile, estimation of purity and hydrophobicity of the API, maximum absorbance wavelength (<em>λ</em>max), (M+H)1+ data of the NCE, and any observed impurities. These initial data are used for determining the next logical steps in method fine-tuning.</p><p class="pb-2">The process is often modified for polar or water-soluble NCEs, which may be better retained on an AQ-type-C18 or polar-embedded column (2). For drug candidates with low or no UV chromophoric activities, detectors such as CAD, ELSD, or MS may be employed. One crucial issue in the initial method development of NCEs is the rare availability of an “ideal test mix” sample containing the API and all key impurities or degradation products, deterring a systematic application of automation systems. This dilemma of sample availability will be discussed later.</p><p class="pb-2"></p><p class="pb-2"><strong>Step 4: Method Fine-Tuning and Optimization</strong></p><p class="pb-2">This is the most time-consuming step for the development of stability-indicating procedures. The process is typically reliant on “selectivity tuning” by changing selectivity (<em>α</em>) in a rational fashion by adjusting mobile phases (organic modifier, pH, buffer strength) and operating parameters (flow [<em>F</em>], gradient time [<em>t</em>G], column temperature [<em>T</em>]) (1–3). Often, changing to a column packed with different bonded phases other than C18 may be needed (such as, for example, phenyl, polar-embedded, or cyano) to achieve the separation of a critical pair of coeluting peaks.</p><p class="pb-2">The next step is often to employ a “shallow middle gradient segment” indexed to the hydrophobicity of the API to increase the resolution around the main component (2). This use of a “multi-segment gradient approach” is preferred for complex NCEs and is discussed later.</p><p class="pb-2">The method fine-tuning or optimization process typically takes a few days or 1 to 2 weeks, depending on the complexity of the NCE and the availability of key impurities as reference materials (such as isomers) that are used as retention time markers. This process is often iterative, and is performed before or after the initial forced degradation studies where degradation products are generated to challenge the separation power of the initial method. Peak purity should be evaluated with PDA and MS. Quite often, the initial column used (for example, C18) is found to be inadequate in the separation of a critical pair (for example, API and the immediate synthetic precursor) (2). This would invariably trigger a column screening experiment to find a better column with a different selectivity (for example, phenyl, polar-embedded, or cyano) (2,3). The use of MS can be a valuable tool in column screening, as it can help to track known impurities from column to column as well as degradation products formed during forced degradation studies. Knowledge of the molecular weights helps to determine the molecular structures of the degradation products.</p><p class="pb-2">For laboratories specializing in method development, the use of automated column and mobile-phase screening systems and other software platforms can expedite this time-consuming step. The last steps in the method development phase are the final minor method adjustments needed to improve sensitivity and peak shape (injection volume, sample concentration, diluent, monitoring wavelength), and analysis time.</p><p class="pb-2">It should also be noted that the drug product will also require assays and impurity analysis throughout the life cycle of the NCE. The best and shortest approach to DP method development is to use the chromatographic conditions for the DS with a modified sample preparation procedure.</p><p class="pb-2"></p><p class="pb-2"><strong>Step 5: Method Prequalification</strong></p><p class="pb-2">Step 5 for methods used to test regulated products is a method prequalification or prevalidation step. This step will ensure the method can be successfully validated by determining the potential to pass typical method validation criteria (2,16), including specificity, precision, linearity, sensitivity, and often accuracy also. This prequalification step can take from a few hours to 1 or 2 d for most methods.</p><p class="pb-2"><strong>Examples of the Selectivity Tuning Approach by Changing Mobile Phase, Column, or Both</strong></p><p class="pb-2">Figures 1 to 3 show studies of the use of selectivity tuning by changing the mobile phase, column, or both. Figure 1 shows the separation of a 12-component test mixture of basic, acidic, and neutral drugs and the changes in peak spacings with the gradient separation on a C18 column by switching the organic mobile phase (MPB) from methanol to acetonitrile. Note that acetonitrile is a stronger organic modifier in RPLC; thus, the elution time is considerably shorter. The peak shapes are also sharper due to its lower viscosity (1,2). While the elution order remains the same without any peak crossovers, the band spacings are changed due to selectivity differences. Note that acetonitrile is an aprotic solvent, while methanol is capable of hydrogen bonding and polar interaction with the analytes. In cases of analytes that can hydrogen-bond or have polar interaction, the elution order may be different when changing from methanol to acetonitrile.</p><p class="pb-2"></p><div class="flex justify-center"><div style="width:30%;float:;max-width:525px;margin:0 auto 1rem;clear:both;cursor:pointer" class=" figure"><div class="flex-none relative text-center"><span style="box-sizing:border-box;display:inline-block;overflow:hidden;width:initial;height:initial;background:none;opacity:1;border:0;margin:0;padding:0;position:relative;max-width:100%"><span style="box-sizing:border-box;display:block;width:initial;height:initial;background:none;opacity:1;border:0;margin:0;padding:0;max-width:100%"><img style="display:block;max-width:100%;width:initial;height:initial;background:none;opacity:1;border:0;margin:0;padding:0" alt="" aria-hidden="true" src="data:image/svg+xml,%3csvg%20xmlns=%27http://www.w3.org/2000/svg%27%20version=%271.1%27%20width=%273215%27%20height=%271850%27/%3e"/></span><img alt="" title="" src="data:image/gif;base64,R0lGODlhAQABAIAAAAAAAP///yH5BAEAAAAALAAAAAABAAEAAAIBRAA7" decoding="async" data-nimg="intrinsic" style="position:absolute;top:0;left:0;bottom:0;right:0;box-sizing:border-box;padding:0;border:none;margin:auto;display:block;width:0;height:0;min-width:100%;max-width:100%;min-height:100%;max-height:100%;object-fit:contain"/><noscript><img alt="" title="" srcSet="/_next/image?url=https%3A%2F%2Fcdn.sanity.io%2Fimages%2F0vv8moc6%2Fchroma%2F9f9a18dee59169b7e0c20e1bd32d036e32258f4e-3215x1850.jpg%3Ffit%3Dcrop%26auto%3Dformat&w=3840&q=75 1x" src="/_next/image?url=https%3A%2F%2Fcdn.sanity.io%2Fimages%2F0vv8moc6%2Fchroma%2F9f9a18dee59169b7e0c20e1bd32d036e32258f4e-3215x1850.jpg%3Ffit%3Dcrop%26auto%3Dformat&w=3840&q=75" decoding="async" data-nimg="intrinsic" style="position:absolute;top:0;left:0;bottom:0;right:0;box-sizing:border-box;padding:0;border:none;margin:auto;display:block;width:0;height:0;min-width:100%;max-width:100%;min-height:100%;max-height:100%;object-fit:contain" loading="lazy"/></noscript></span></div><p class="text-gray-500 italic text-sm">Figure 1: The comparative chromatograms illustrate the use of selectivity tuning by different organic solvents. Chromatograms courtesy of Waters Corporation.</p><div class="top-[-100%] block w-[1px] transition-opacity duration-500 ease-in-out opacity-0 overflow-hidden"><img class="m-auto absolute inset-0 max-w-[0%] max-h-[0%] border-[3px] border-solid border-white shadow-[0px_0px_8px_rgba(0,0,0,0.3)] box-border transition ease-in-out duration-500" src="https://cdn.sanity.io/images/0vv8moc6/chroma/9f9a18dee59169b7e0c20e1bd32d036e32258f4e-3215x1850.jpg?fit=crop&auto=format"/></div></div><style> #image-caption p{ font-size: 12px; max-width: 525px; margin: 0 auto; text-align: center; } </style></div><p class="pb-2">Figure 2 shows eight comparative chromatograms of a 7-component mixture of basic drugs using columns packed with different types of C18, phenyl, cyano, and pentafluorophenyl phases from a single manufacturer. All columns have the same dimension and are packed with similar particle sizes of ~1.7 µm. Chromatograms show similar elution order but with many differences in band spacings for C18 phases, whose predominant retention mechanism is hydrophobic interaction. However, the elution order can be substantially different in columns packed with different bonded phases that have additional retention mechanisms from π-π, polar, and hydrogen bonding interactions. To find the best column for a specific separation, the most efficient approach is to use an automated column and mobile phase screening system (2,3,12).</p><p class="pb-2"></p><div class="flex justify-center"><div style="width:30%;float:;max-width:525px;margin:0 auto 1rem;clear:both;cursor:pointer" class=" figure"><div class="flex-none relative text-center"><span style="box-sizing:border-box;display:inline-block;overflow:hidden;width:initial;height:initial;background:none;opacity:1;border:0;margin:0;padding:0;position:relative;max-width:100%"><span style="box-sizing:border-box;display:block;width:initial;height:initial;background:none;opacity:1;border:0;margin:0;padding:0;max-width:100%"><img style="display:block;max-width:100%;width:initial;height:initial;background:none;opacity:1;border:0;margin:0;padding:0" alt="" aria-hidden="true" src="data:image/svg+xml,%3csvg%20xmlns=%27http://www.w3.org/2000/svg%27%20version=%271.1%27%20width=%273128%27%20height=%271851%27/%3e"/></span><img alt="" title="" src="data:image/gif;base64,R0lGODlhAQABAIAAAAAAAP///yH5BAEAAAAALAAAAAABAAEAAAIBRAA7" decoding="async" data-nimg="intrinsic" style="position:absolute;top:0;left:0;bottom:0;right:0;box-sizing:border-box;padding:0;border:none;margin:auto;display:block;width:0;height:0;min-width:100%;max-width:100%;min-height:100%;max-height:100%;object-fit:contain"/><noscript><img alt="" title="" srcSet="/_next/image?url=https%3A%2F%2Fcdn.sanity.io%2Fimages%2F0vv8moc6%2Fchroma%2F99f4daf89c7300a79a894aa2f0513b90f4fc6b04-3128x1851.jpg%3Ffit%3Dcrop%26auto%3Dformat&w=3840&q=75 1x" src="/_next/image?url=https%3A%2F%2Fcdn.sanity.io%2Fimages%2F0vv8moc6%2Fchroma%2F99f4daf89c7300a79a894aa2f0513b90f4fc6b04-3128x1851.jpg%3Ffit%3Dcrop%26auto%3Dformat&w=3840&q=75" decoding="async" data-nimg="intrinsic" style="position:absolute;top:0;left:0;bottom:0;right:0;box-sizing:border-box;padding:0;border:none;margin:auto;display:block;width:0;height:0;min-width:100%;max-width:100%;min-height:100%;max-height:100%;object-fit:contain" loading="lazy"/></noscript></span></div><p class="text-gray-500 italic text-sm">Figure 2: Comparative chromatograms of the gradient separations of a test mix containing seven basic drugs, illustrating the effect of selectivity of bonded phases (C18, phenyl, cyano, pentafluorophenyl [PFP]). All columns are 50 x 2.1 mm, 1.7-µm, with 10-mM ammonium formate at pH 3, and the same linear gradient with methanol. Diagram courtesy of Waters Corporation.</p><div class="top-[-100%] block w-[1px] transition-opacity duration-500 ease-in-out opacity-0 overflow-hidden"><img class="m-auto absolute inset-0 max-w-[0%] max-h-[0%] border-[3px] border-solid border-white shadow-[0px_0px_8px_rgba(0,0,0,0.3)] box-border transition ease-in-out duration-500" src="https://cdn.sanity.io/images/0vv8moc6/chroma/99f4daf89c7300a79a894aa2f0513b90f4fc6b04-3128x1851.jpg?fit=crop&auto=format"/></div></div><style> #image-caption p{ font-size: 12px; max-width: 525px; margin: 0 auto; text-align: center; } </style></div><p class="pb-2">Figure 3 shows two comparative chromatograms in a case study on proactive phase-appropriate method development advocated by Rasmussen and associates (3,17). The top chromatogram shows the separation of a retention marker solution of an API spiked with available impurities that is analyzed by a primary stability-indicating method for a DS method using a C18 column and an MPA at pH 2.5. The bottom chromatogram shows the separation of the same test mix using the secondary orthogonal method on a polar-embedded phase at a neutral MPA pH. More discussion on the development of a secondary orthogonal method is found in a later section.</p><p class="pb-2"></p><div class="flex justify-center"><div style="width:30%;float:;max-width:525px;margin:0 auto 1rem;clear:both;cursor:pointer" class=" figure"><div class="flex-none relative text-center"><span style="box-sizing:border-box;display:inline-block;overflow:hidden;width:initial;height:initial;background:none;opacity:1;border:0;margin:0;padding:0;position:relative;max-width:100%"><span style="box-sizing:border-box;display:block;width:initial;height:initial;background:none;opacity:1;border:0;margin:0;padding:0;max-width:100%"><img style="display:block;max-width:100%;width:initial;height:initial;background:none;opacity:1;border:0;margin:0;padding:0" alt="" aria-hidden="true" src="data:image/svg+xml,%3csvg%20xmlns=%27http://www.w3.org/2000/svg%27%20version=%271.1%27%20width=%273279%27%20height=%272025%27/%3e"/></span><img alt="" title="" src="data:image/gif;base64,R0lGODlhAQABAIAAAAAAAP///yH5BAEAAAAALAAAAAABAAEAAAIBRAA7" decoding="async" data-nimg="intrinsic" style="position:absolute;top:0;left:0;bottom:0;right:0;box-sizing:border-box;padding:0;border:none;margin:auto;display:block;width:0;height:0;min-width:100%;max-width:100%;min-height:100%;max-height:100%;object-fit:contain"/><noscript><img alt="" title="" srcSet="/_next/image?url=https%3A%2F%2Fcdn.sanity.io%2Fimages%2F0vv8moc6%2Fchroma%2F48dd66261710c1c5b74ad58d4c0af1e1393547ae-3279x2025.jpg%3Ffit%3Dcrop%26auto%3Dformat&w=3840&q=75 1x" src="/_next/image?url=https%3A%2F%2Fcdn.sanity.io%2Fimages%2F0vv8moc6%2Fchroma%2F48dd66261710c1c5b74ad58d4c0af1e1393547ae-3279x2025.jpg%3Ffit%3Dcrop%26auto%3Dformat&w=3840&q=75" decoding="async" data-nimg="intrinsic" style="position:absolute;top:0;left:0;bottom:0;right:0;box-sizing:border-box;padding:0;border:none;margin:auto;display:block;width:0;height:0;min-width:100%;max-width:100%;min-height:100%;max-height:100%;object-fit:contain" loading="lazy"/></noscript></span></div><p class="text-gray-500 italic text-sm">Figure 3: Two comparative HPLC chromatograms of a primary regulatory method (top) and a secondary orthogonal method (bottom) used in the phase-appropriate method development approach advocated by H. Rasmussen and associates (3). Reprint from reference (3).</p><div class="top-[-100%] block w-[1px] transition-opacity duration-500 ease-in-out opacity-0 overflow-hidden"><img class="m-auto absolute inset-0 max-w-[0%] max-h-[0%] border-[3px] border-solid border-white shadow-[0px_0px_8px_rgba(0,0,0,0.3)] box-border transition ease-in-out duration-500" src="https://cdn.sanity.io/images/0vv8moc6/chroma/48dd66261710c1c5b74ad58d4c0af1e1393547ae-3279x2025.jpg?fit=crop&auto=format"/></div></div><style> #image-caption p{ font-size: 12px; max-width: 525px; margin: 0 auto; text-align: center; } </style></div><p class="pb-2"><strong>A Summary of Suggested Parameter Selections for Steps 3 and 4</strong></p><p class="pb-2">A summary of suggested parameter selections for steps 3 and 4 is listed in Table II as a reference guide for default conditions in HPLC method development for NCEs.</p><p class="pb-2"></p><div class="flex justify-center"><div style="width:30%;float:;max-width:525px;margin:0 auto 1rem;clear:both;cursor:pointer" class=" figure"><div class="flex-none relative text-center"><span style="box-sizing:border-box;display:inline-block;overflow:hidden;width:initial;height:initial;background:none;opacity:1;border:0;margin:0;padding:0;position:relative;max-width:100%"><span style="box-sizing:border-box;display:block;width:initial;height:initial;background:none;opacity:1;border:0;margin:0;padding:0;max-width:100%"><img style="display:block;max-width:100%;width:initial;height:initial;background:none;opacity:1;border:0;margin:0;padding:0" alt="" aria-hidden="true" src="data:image/svg+xml,%3csvg%20xmlns=%27http://www.w3.org/2000/svg%27%20version=%271.1%27%20width=%27642%27%20height=%27647%27/%3e"/></span><img alt="" title="" src="data:image/gif;base64,R0lGODlhAQABAIAAAAAAAP///yH5BAEAAAAALAAAAAABAAEAAAIBRAA7" decoding="async" data-nimg="intrinsic" style="position:absolute;top:0;left:0;bottom:0;right:0;box-sizing:border-box;padding:0;border:none;margin:auto;display:block;width:0;height:0;min-width:100%;max-width:100%;min-height:100%;max-height:100%;object-fit:contain"/><noscript><img alt="" title="" srcSet="/_next/image?url=https%3A%2F%2Fcdn.sanity.io%2Fimages%2F0vv8moc6%2Fchroma%2F67cd8dfc92c0ddd02e1ab1f569d3ee326c0daf55-642x647.jpg%3Ffit%3Dcrop%26auto%3Dformat&w=750&q=75 1x, /_next/image?url=https%3A%2F%2Fcdn.sanity.io%2Fimages%2F0vv8moc6%2Fchroma%2F67cd8dfc92c0ddd02e1ab1f569d3ee326c0daf55-642x647.jpg%3Ffit%3Dcrop%26auto%3Dformat&w=1920&q=75 2x" src="/_next/image?url=https%3A%2F%2Fcdn.sanity.io%2Fimages%2F0vv8moc6%2Fchroma%2F67cd8dfc92c0ddd02e1ab1f569d3ee326c0daf55-642x647.jpg%3Ffit%3Dcrop%26auto%3Dformat&w=1920&q=75" decoding="async" data-nimg="intrinsic" style="position:absolute;top:0;left:0;bottom:0;right:0;box-sizing:border-box;padding:0;border:none;margin:auto;display:block;width:0;height:0;min-width:100%;max-width:100%;min-height:100%;max-height:100%;object-fit:contain" loading="lazy"/></noscript></span></div><div class="top-[-100%] block w-[1px] transition-opacity duration-500 ease-in-out opacity-0 overflow-hidden"><img class="m-auto absolute inset-0 max-w-[0%] max-h-[0%] border-[3px] border-solid border-white shadow-[0px_0px_8px_rgba(0,0,0,0.3)] box-border transition ease-in-out duration-500" src="https://cdn.sanity.io/images/0vv8moc6/chroma/67cd8dfc92c0ddd02e1ab1f569d3ee326c0daf55-642x647.jpg?fit=crop&auto=format"/></div></div><style> #image-caption p{ font-size: 12px; max-width: 525px; margin: 0 auto; text-align: center; } </style></div><p class="pb-2">During the life cycle of any DS or DP, the analytical methods may need to be redeveloped. A new synthetic route or process chemistry changes during scale-up may cause new impurities to be present in the final DS. Also, degradation products found in samples from stability studies may require an improved resolution for quantitation.</p><p class="pb-2"><strong>Method Development Approaches and Automation Tools</strong></p><p class="pb-2">In this section, we describe modern approaches in method development and common automated tools for expediting the process. The reader is referred to textbooks, articles, and manufacturers’ websites for updates and more complete descriptions (18–29). Prior to discussing the modern development approaches, let us discuss briefly sample diluent selection for the NCE and sample preparation for DS and DP.</p><p class="pb-2"><strong>Selection of Sample Diluent and Sample Preparation Procedure</strong></p><p class="pb-2">Knowledge about the solubility properties of the API is necessary to choose the most appropriate sample diluent. The most natural choice is to use the initial gradient concentration of the mobile phase. Although this approach may work for hydrophilic or water-soluble compounds, many hydrophobic compounds may not be fully dissolved in these mostly aqueous diluents. Increasing the organic phase concentration may result in full dissolution. However, a higher concentration of organic solvent in the sample diluents may cause chromatographic peak anomaly issues, such as peak splitting upon the injection of large sample volumes (2). Another approach may be the use of a stronger solubilizing agent (such as DMSO), in small concentrations to solubilize the compound and then dilute with the starting concentration of the mobile phase. Often, vigorous shaking manually or with a shaker, or sonication, may be required to expedite the solubilization process. Filtration of a drug substance sample is not recommended since the material must be completely dissolved in a solution for accurate quantitation.</p><p class="pb-2">Drug products, such as tablets, also have the added complications of the need to break down the formulation matrix to permit efficient and complete extraction and solubilization of the active ingredients. The separation can be especially problematic upon stability storage due to the aging of the dosage form. Multi-step dilution schemes using shakers or sonication in an appropriate extraction medium followed by filtration (such as 13–25 mm, i.d., 0.2–0.45-µm disposable membrane syringe filters) or centrifugation is generally required to obtain the final sample DP extract for analysis. For sustained-release drug product formulations, a 2-step extraction process is often needed, using an organic solvent to dissolve the polymer-based matrix in the first step. Grinding or rough-crushing the formulation may also be needed to expedite the extraction process. More detailed procedures are available in these references (2,3).</p><p class="pb-2"><strong>Modern Method Development Approaches and Trends</strong></p><p class="pb-2"><strong>UHPLC</strong></p><p class="pb-2">UHPLC is a modern low-dispersion system platform with higher-pressure ratings (15,000–22,500 psi), and is the most significant innovation in HPLC in recent years (18–23). The benefits of UHPLC, when coupled with small-particle columns (sub-2 and sub-3-μm), are faster analysis, enhanced sensitivity, and higher peak capacities for sample analysis (13, 22). The lower system dwell volumes and faster column equilibration times for the smaller UHPLC columns provide another significant benefit for the method development process (12,22). In method optimization, the mobile phase and operating conditions are varied in numerous trial experiments and iterations to optimize the chromatographic behavior of all key analytes to arrive at the optimal separation. The judicious application of UHPLC can reduce method development times by a factor of 3 to 5 in comparison with those obtained with conventional HPLC systems and columns. In addition, UHPLC significantly reduces the amount of solvents used and solvent waste (22).</p><p class="pb-2">A potential issue for using UHPLC in method development is the necessity to “back-translate” (also often called “back-transfer” in the literature) or convert the UHPLC methods back to HPLC conditions because many QC laboratories may not be equipped with UHPLC (2,18,23). Today, 16 years after the commercialization of the UHPLC system in 2004 (18), the need for changing the method from UHPLC back to HPLC is lessened by the wider availability of these UHPLC systems (>15,000 psi), and others with intermediary pressures (for example, 9,000–2,000 psi) (19,20).</p><p class="pb-2"></p><p class="pb-2"><strong>MS</strong></p><p class="pb-2">While most stability-indicating analytical procedures developed for NCEs are HPLC-UV methods, many are also beneficially designed to be MS-compatible using volatile reagents in the mobile phases to allow peak verification, tracking, and identification (2,3). The inclusion of an information-rich MS in the HPLC-UV method development system, in our view, is mandatory for a science-based and efficient method development process, and particularly useful for developing methods of complex NCEs. The MS detector is immensely helpful in the case that the impurities must be identified or qualified.</p><p class="pb-2">The advent of low-cost, easy-to-use single-quadrupole MS (SQMS) makes this adoption much easier for any analytical chemist without specialized MS training (2,19). The only downside is the loss in sensitivity and linear performance for detection wavelength <230 nm due tothe end absorbance of the volatile mobile phase additives (such as formic acid).</p><p class="pb-2"></p><p class="pb-2"><strong>Phase-Appropriate Method Development and Validation</strong></p><p class="pb-2">The concept of “phase-appropriate method development and validation,”’ advocated by H. Rasmussen and associates and others in the early 2000s, recognizes that it is unrealistic to expect the original stability-indicating method for an NCE to remain unchanged during the life cycle of a new drug candidate to commercialization (3,17). It is, therefore, more realistic to have a phase-appropriate or tiered approach, in which the initial method is continuously improved as the formulation is being developed. Complete validation studies are conducted as the project is advancing to late-phase development when the synthetic chemistry process and drug product formulation are finalized.</p><p class="pb-2">The approach recommends the development of a secondary orthogonal method early for several advantages (17). While the word <em>orthogonal separation</em>generally means using different retention mechanisms (for example, RPLC based on hydrophobic interaction vs. capillary electrophoresis based on the ionic mobility of the analytes), in reality, most orthogonal methods employ two columns with different selectivity (C18 vs. polar-embedded) or the same column using different organic modifiers (acetonitrile vs. methanol). The secondary orthogonal method ensures that there is no hidden impurities underneath the API peak. It can be used to analyze pivotal clinical lots for supporting data. A minimum method validation can be done to expedite the testing. In addition, the orthogonal method can be used when the primary method is found to be inadequate (such as the inability to resolve a new impurity). This approach can reduce the risk of a potential method deficiency situation, which can have a severe impact on the drug development timeline. Case studies to illustrate this approach are shown in Figures 3 and 5.</p><p class="pb-2"><strong>Applications of Quality by Design (QbD) and Design of Experiments (DoE) in Method Development</strong></p><p class="pb-2">Regulatory authorities have endorsed a science- and risk-based strategy in new drug development, using a systematic Quality by Design (QbD) approach in process development and control of critical raw materials (24). The QbD concept can also be used in method development to establish the capabilities of the method. While a traditional “one-factor-at-a-time”approach is widely practiced in method development, many laboratories have started to use a Design of Experiments (DoE) approach for method robustness validation (3,5). Others have explored the use of automated scouting or screening systems and software platforms for the method development process (2,3,25–27).</p><p class="pb-2"></p><p class="pb-2"><strong>Automation and Software Platform Systems for Method Development</strong></p><p class="pb-2">Although most HPLC systems can be post-fitted with selection valves to automate the column/mobile phase screening studies (2,3,12), many manufacturers now offer preconfigured method scouting and screening systems, often with some simple optimization algorithms. They can also work with more elaborate software platforms to facilitate the method development process (2).</p><p class="pb-2">Table III lists automated method scouting or screening systems and software platforms for HPLC method development. Many software platforms are available for off-line predictive modeling with inputs from limited experiments (such as DryLab) (2,4,25). Other platforms support direct instrument control and on-line optimization (such as ChromSword Auto and ACD Labs/AutoChrom) and statistical analysis of experimental results (such as Fusion QbD) (2,26–27). The reader is referred to published journal articles and the manufacturers’ websites for further details (25–27).</p><p class="pb-2"></p><div class="flex justify-center"><div style="width:30%;float:;max-width:525px;margin:0 auto 1rem;clear:both;cursor:pointer" class=" figure"><div class="flex-none relative text-center"><span style="box-sizing:border-box;display:inline-block;overflow:hidden;width:initial;height:initial;background:none;opacity:1;border:0;margin:0;padding:0;position:relative;max-width:100%"><span style="box-sizing:border-box;display:block;width:initial;height:initial;background:none;opacity:1;border:0;margin:0;padding:0;max-width:100%"><img style="display:block;max-width:100%;width:initial;height:initial;background:none;opacity:1;border:0;margin:0;padding:0" alt="" aria-hidden="true" src="data:image/svg+xml,%3csvg%20xmlns=%27http://www.w3.org/2000/svg%27%20version=%271.1%27%20width=%27578%27%20height=%27733%27/%3e"/></span><img alt="" title="" src="data:image/gif;base64,R0lGODlhAQABAIAAAAAAAP///yH5BAEAAAAALAAAAAABAAEAAAIBRAA7" decoding="async" data-nimg="intrinsic" style="position:absolute;top:0;left:0;bottom:0;right:0;box-sizing:border-box;padding:0;border:none;margin:auto;display:block;width:0;height:0;min-width:100%;max-width:100%;min-height:100%;max-height:100%;object-fit:contain"/><noscript><img alt="" title="" srcSet="/_next/image?url=https%3A%2F%2Fcdn.sanity.io%2Fimages%2F0vv8moc6%2Fchroma%2F4da001b347a31704924056e8c4298b16c1a3babf-578x733.jpg%3Ffit%3Dcrop%26auto%3Dformat&w=640&q=75 1x, /_next/image?url=https%3A%2F%2Fcdn.sanity.io%2Fimages%2F0vv8moc6%2Fchroma%2F4da001b347a31704924056e8c4298b16c1a3babf-578x733.jpg%3Ffit%3Dcrop%26auto%3Dformat&w=1200&q=75 2x" src="/_next/image?url=https%3A%2F%2Fcdn.sanity.io%2Fimages%2F0vv8moc6%2Fchroma%2F4da001b347a31704924056e8c4298b16c1a3babf-578x733.jpg%3Ffit%3Dcrop%26auto%3Dformat&w=1200&q=75" decoding="async" data-nimg="intrinsic" style="position:absolute;top:0;left:0;bottom:0;right:0;box-sizing:border-box;padding:0;border:none;margin:auto;display:block;width:0;height:0;min-width:100%;max-width:100%;min-height:100%;max-height:100%;object-fit:contain" loading="lazy"/></noscript></span></div><div class="top-[-100%] block w-[1px] transition-opacity duration-500 ease-in-out opacity-0 overflow-hidden"><img class="m-auto absolute inset-0 max-w-[0%] max-h-[0%] border-[3px] border-solid border-white shadow-[0px_0px_8px_rgba(0,0,0,0.3)] box-border transition ease-in-out duration-500" src="https://cdn.sanity.io/images/0vv8moc6/chroma/4da001b347a31704924056e8c4298b16c1a3babf-578x733.jpg?fit=crop&auto=format"/></div></div><style> #image-caption p{ font-size: 12px; max-width: 525px; margin: 0 auto; text-align: center; } </style></div><p class="pb-2"><strong>A Dilemma in Early-Phase Method Development</strong></p><p class="pb-2">The use of automated and software systems can expedite the method development process, particularly in laboratories specializing in late-phase product development situations where critical process impurities and degradation products are identified and available as reference materials. This ideal test mix containing all the critical impurities is rarely available during initial method development for an NCE, making it impossible to have a systematic application of automated workflows in early development.</p><p class="pb-2">Nevertheless, the analytical chemist still needs to have a reasonable first HPLC method to initiate sample evaluation from forced degradation studies. The most realistic scenario is to have proactive communication with the process chemist and to obtain the mother liquors of the final crystallization of the API. As a minimum, a mixture of precursors, starting materials, intermediates from previous synthetic steps, plus any additional reference materials available such as stereoisomers, can be assembled for use as method development samples (3,17).</p><p class="pb-2"><strong>Easier Approaches to MethodDevelopment for Pharmaceutical Analysis</strong></p><p class="pb-2">The traditional five-step approach with judicious choice of column, detector, and mobile-phase conditions works well for systematic method development for pharmaceutical analysis when implemented by experienced scientists. However, it would be desirable to have easier approaches to develop effective methods by analysts with diverse experience levels. Here we will describe two such approaches.</p><p class="pb-2"></p><p class="pb-2"><strong>A Three-Pronged Template Approach</strong></p><p class="pb-2">A three-pronged template approach was proposed in 2013 to facilitate the rapid development of early-phase RPLC methods by recognizing the attributes of the three types of HPLC methods commonly used in the pharmaceutical analysis (10). These method templates, with their unique sets of characteristics and capabilities, allow a quicker method development process for scientists by recognizing the attributes and the expected final method conditions (column, operating conditions). These method templates are described below.</p><p class="pb-2"><em>Template 1. Fast (sub-2-min) LC isocratic methods</em> for rough assays (potency of DS or strength of DP) used in content uniformity and dissolution (performance) testing of drug products (2). These are non-stability-indicating procedures for the determination of the main component (assay) only. They can be developed and qualified quickly. Note that this method type is not adequate to be used for actual potency assay of a DS or purity factor of a DS on a certificate of analysis (CoA), which must be derived from a validated stability-indicating method or method template #3.</p><p class="pb-2"></p><p class="pb-2"><em>Template 2. Generic broad-gradient RPLC methods</em> can be used for high-throughput screening (1–2 min) (5,28) or in-process control testing (4–10 min) (2,5). Still, the broad gradient RPLC methods can also be re-purposed for purity assays of simpler samples such as raw materials, starting materials, reagents, and cleaning verification (30) samples. The generic methods can be easily modified for stability-indicating assays of simpler drug molecules by extending the gradient times (<em>t</em>G) or using a more complex gradient profile. An organization can adopt a few generic broad-gradient methods for applications across different early development projects to reduce to burden for method development. This practice can save considerable analytical resources, reduce the method development, validation, and transfer time, and the stockpile of different HPLC columns by individual scientists within an organization (29).</p><p class="pb-2"></p><p class="pb-2"><em>Template 3. Multi-segment gradient methods. </em>A brief survey of literature conducted in 2013 indicated a predominance of multi-segment gradient methods for ICH-compliant stability-indicating analytical procedures for complex NCEs (2,10). The rationales for this unique gradient pattern (see Figure 4) are likely to be as follows:</p><p class="pb-2"></p><div class="flex justify-center"><div style="width:30%;float:;max-width:525px;margin:0 auto 1rem;clear:both;cursor:pointer" class=" figure"><div class="flex-none relative text-center"><span style="box-sizing:border-box;display:inline-block;overflow:hidden;width:initial;height:initial;background:none;opacity:1;border:0;margin:0;padding:0;position:relative;max-width:100%"><span style="box-sizing:border-box;display:block;width:initial;height:initial;background:none;opacity:1;border:0;margin:0;padding:0;max-width:100%"><img style="display:block;max-width:100%;width:initial;height:initial;background:none;opacity:1;border:0;margin:0;padding:0" alt="" aria-hidden="true" src="data:image/svg+xml,%3csvg%20xmlns=%27http://www.w3.org/2000/svg%27%20version=%271.1%27%20width=%273157%27%20height=%272143%27/%3e"/></span><img alt="" title="" src="data:image/gif;base64,R0lGODlhAQABAIAAAAAAAP///yH5BAEAAAAALAAAAAABAAEAAAIBRAA7" decoding="async" data-nimg="intrinsic" style="position:absolute;top:0;left:0;bottom:0;right:0;box-sizing:border-box;padding:0;border:none;margin:auto;display:block;width:0;height:0;min-width:100%;max-width:100%;min-height:100%;max-height:100%;object-fit:contain"/><noscript><img alt="" title="" srcSet="/_next/image?url=https%3A%2F%2Fcdn.sanity.io%2Fimages%2F0vv8moc6%2Fchroma%2Fd54f052ffc4258219574260f8f9b32fc38cb0b6d-3157x2143.jpg%3Ffit%3Dcrop%26auto%3Dformat&w=3840&q=75 1x" src="/_next/image?url=https%3A%2F%2Fcdn.sanity.io%2Fimages%2F0vv8moc6%2Fchroma%2Fd54f052ffc4258219574260f8f9b32fc38cb0b6d-3157x2143.jpg%3Ffit%3Dcrop%26auto%3Dformat&w=3840&q=75" decoding="async" data-nimg="intrinsic" style="position:absolute;top:0;left:0;bottom:0;right:0;box-sizing:border-box;padding:0;border:none;margin:auto;display:block;width:0;height:0;min-width:100%;max-width:100%;min-height:100%;max-height:100%;object-fit:contain" loading="lazy"/></noscript></span></div><p class="text-gray-500 italic text-sm">Figure 4: An example of a gradient profile of the “multi-segment gradient method template #3” using a shallow middle segment (15–40% B in 25 min) with the main component eluted toward the end of the gradient segment. This segment is preceded by an early segment (5–15% B in 5 min) and followed by a steep segment (40–90% B in 3 min) with a 2-min purging step at 90% B. Reprinted from reference (10).</p><div class="top-[-100%] block w-[1px] transition-opacity duration-500 ease-in-out opacity-0 overflow-hidden"><img class="m-auto absolute inset-0 max-w-[0%] max-h-[0%] border-[3px] border-solid border-white shadow-[0px_0px_8px_rgba(0,0,0,0.3)] box-border transition ease-in-out duration-500" src="https://cdn.sanity.io/images/0vv8moc6/chroma/d54f052ffc4258219574260f8f9b32fc38cb0b6d-3157x2143.jpg?fit=crop&auto=format"/></div></div><style> #image-caption p{ font-size: 12px; max-width: 525px; margin: 0 auto; text-align: center; } </style></div><p class="pb-2">Isomers, impurities, and degradants of the API usually have similar structures and hydrophobicity to those of the parent molecule and thus may be eluted close to the API under RPLC.</p><p class="pb-2">A shallow gradient with the API eluted toward the end of the gradient segment would maximize the resolution around the API peak. The hydrophobicity of the API defines the final %MPB of this segment.</p><p class="pb-2">A steep gradient segment, followed by a purging step, is used to elute highly-retained components (dimers). An initial low-strength gradient segment (starting at 2–5% MPB) may be required to retain polar impurities (such as hydrolytic degradants).</p><p class="pb-2"></p><p class="pb-2">Traditionally, a single, broad, linear gradient is used during initial method development and column screening. This fast gradient approach is acceptable for initial phase screening but is unlikely to provide sufficient resolution around the API to resolve closely eluted impurities. The understanding of the rationales for the multi-segment gradient program offers helpful insights into the fine-tuning method development steps used in method optimization (step 4). Note that linear gradient segments are invariably used, and isocratic steps should be avoided to reduce method transfer issues between different HPLC or UHPLC systems.</p><p class="pb-2"><strong>Case Studies to Illustrate the Use of Multi-Segment Gradient Approach for Complex DS and DP Methods</strong></p><p class="pb-2">Two case studies are included here to illustrate the application of this multi-segment gradient approach in the method development of complex pharmaceuticals (13). The third case study is an early UHPLC method development example of an NCE DS method and the “back-transfer” to HPLC conditions (9).</p><p class="pb-2"></p><p class="pb-2"><strong>A Complex NCE with Three Chiral Centers</strong></p><p class="pb-2">Figure 5a shows a chromatogram in a method development case study for a complex molecule with three chiral centers. Here, the resolution of the four pairs of diastereomers becomes the crucial criterion for quality assessment (13). The middle gradient segment employed is a shallow gradient (15–40%B in 25 min) used to separate the API (with an absolute configuration of SRR) from its diastereomers (SRS, RRR, and RRS) and other impurities (M416, M456, and M399, designated as their parent (M+H)1+ ions). A low-strength initial gradient allows for the retention of a hydrolytic degradant (M235), while the final segment depicts a steep gradient that elutes any dimers or other late-eluting species. Note that this 42-min HPLC method has been converted into a 17-min UHPLC method using a 100-mm column packed with 2-µm particles with equal resolution performance (13).</p><p class="pb-2"></p><div class="flex justify-center"><div style="width:30%;float:;max-width:525px;margin:0 auto 1rem;clear:both;cursor:pointer" class=" figure"><div class="flex-none relative text-center"><span style="box-sizing:border-box;display:inline-block;overflow:hidden;width:initial;height:initial;background:none;opacity:1;border:0;margin:0;padding:0;position:relative;max-width:100%"><span style="box-sizing:border-box;display:block;width:initial;height:initial;background:none;opacity:1;border:0;margin:0;padding:0;max-width:100%"><img style="display:block;max-width:100%;width:initial;height:initial;background:none;opacity:1;border:0;margin:0;padding:0" alt="" aria-hidden="true" src="data:image/svg+xml,%3csvg%20xmlns=%27http://www.w3.org/2000/svg%27%20version=%271.1%27%20width=%273138%27%20height=%272355%27/%3e"/></span><img alt="" title="" src="data:image/gif;base64,R0lGODlhAQABAIAAAAAAAP///yH5BAEAAAAALAAAAAABAAEAAAIBRAA7" decoding="async" data-nimg="intrinsic" style="position:absolute;top:0;left:0;bottom:0;right:0;box-sizing:border-box;padding:0;border:none;margin:auto;display:block;width:0;height:0;min-width:100%;max-width:100%;min-height:100%;max-height:100%;object-fit:contain"/><noscript><img alt="" title="" srcSet="/_next/image?url=https%3A%2F%2Fcdn.sanity.io%2Fimages%2F0vv8moc6%2Fchroma%2F43c79f7358c7fa14971db2af655ae2b8c6622ad1-3138x2355.jpg%3Ffit%3Dcrop%26auto%3Dformat&w=3840&q=75 1x" src="/_next/image?url=https%3A%2F%2Fcdn.sanity.io%2Fimages%2F0vv8moc6%2Fchroma%2F43c79f7358c7fa14971db2af655ae2b8c6622ad1-3138x2355.jpg%3Ffit%3Dcrop%26auto%3Dformat&w=3840&q=75" decoding="async" data-nimg="intrinsic" style="position:absolute;top:0;left:0;bottom:0;right:0;box-sizing:border-box;padding:0;border:none;margin:auto;display:block;width:0;height:0;min-width:100%;max-width:100%;min-height:100%;max-height:100%;object-fit:contain" loading="lazy"/></noscript></span></div><p class="text-gray-500 italic text-sm">Figure 5: Chromatograms illustrating the applications of template #3 in the separation of the four diastereomers in a multi-chiral NCEs with three chiral centers described in reference 13. Column and full operating conditions are shown in the inset. (a) the 42-min primary regulatory HPLC method using a C18 column with acetonitrile; (b) a secondary orthogonal method using a phenyl column and methanol.</p><div class="top-[-100%] block w-[1px] transition-opacity duration-500 ease-in-out opacity-0 overflow-hidden"><img class="m-auto absolute inset-0 max-w-[0%] max-h-[0%] border-[3px] border-solid border-white shadow-[0px_0px_8px_rgba(0,0,0,0.3)] box-border transition ease-in-out duration-500" src="https://cdn.sanity.io/images/0vv8moc6/chroma/43c79f7358c7fa14971db2af655ae2b8c6622ad1-3138x2355.jpg?fit=crop&auto=format"/></div></div><style> #image-caption p{ font-size: 12px; max-width: 525px; margin: 0 auto; text-align: center; } </style></div><p class="pb-2">Figure 5b shows a chromatogram of the secondary orthogonal method developed at the same time, which yields a better resolution of the diastereomers using a phenyl column and methanol. Nevertheless, the HPLC conditions used in Figure 5a with an analysis time of 42 min was employed as the primary regulatory method due to its higher overall resolution and peak capacity. The case study also illustrates the implementation of a proactive method development approach using a secondary orthogonal method to ensure there are no impurities hidden underneath the API peak (2,3).</p><p class="pb-2"></p><p class="pb-2"><strong>A Method for a Complex DP with Multiple APIs</strong></p><p class="pb-2">Figure 6 shows a UHPLC-UV chromatogram of a retention marker solution consisting of 60+ components used in a stability-indicating method for a complex DP with four APIs (Strilbild tablet for HIV indication). The method uses a 5-segment linear gradient profile customized to maximize the resolution of the four APIs. The method development process utilized a software-assisted approach using the QbD principle (13,27). This procedure has been successfully validated, and a validation summary data is available from the reference paper (13).</p><p class="pb-2"></p><div class="flex justify-center"><div style="width:30%;float:;max-width:525px;margin:0 auto 1rem;clear:both;cursor:pointer" class=" figure"><div class="flex-none relative text-center"><span style="box-sizing:border-box;display:inline-block;overflow:hidden;width:initial;height:initial;background:none;opacity:1;border:0;margin:0;padding:0;position:relative;max-width:100%"><span style="box-sizing:border-box;display:block;width:initial;height:initial;background:none;opacity:1;border:0;margin:0;padding:0;max-width:100%"><img style="display:block;max-width:100%;width:initial;height:initial;background:none;opacity:1;border:0;margin:0;padding:0" alt="" aria-hidden="true" src="data:image/svg+xml,%3csvg%20xmlns=%27http://www.w3.org/2000/svg%27%20version=%271.1%27%20width=%272912%27%20height=%271422%27/%3e"/></span><img alt="" title="" src="data:image/gif;base64,R0lGODlhAQABAIAAAAAAAP///yH5BAEAAAAALAAAAAABAAEAAAIBRAA7" decoding="async" data-nimg="intrinsic" style="position:absolute;top:0;left:0;bottom:0;right:0;box-sizing:border-box;padding:0;border:none;margin:auto;display:block;width:0;height:0;min-width:100%;max-width:100%;min-height:100%;max-height:100%;object-fit:contain"/><noscript><img alt="" title="" srcSet="/_next/image?url=https%3A%2F%2Fcdn.sanity.io%2Fimages%2F0vv8moc6%2Fchroma%2Fd0d0b6bed0948d5667bb7434cdbac9d25cea1f42-2912x1422.jpg%3Ffit%3Dcrop%26auto%3Dformat&w=3840&q=75 1x" src="/_next/image?url=https%3A%2F%2Fcdn.sanity.io%2Fimages%2F0vv8moc6%2Fchroma%2Fd0d0b6bed0948d5667bb7434cdbac9d25cea1f42-2912x1422.jpg%3Ffit%3Dcrop%26auto%3Dformat&w=3840&q=75" decoding="async" data-nimg="intrinsic" style="position:absolute;top:0;left:0;bottom:0;right:0;box-sizing:border-box;padding:0;border:none;margin:auto;display:block;width:0;height:0;min-width:100%;max-width:100%;min-height:100%;max-height:100%;object-fit:contain" loading="lazy"/></noscript></span></div><p class="text-gray-500 italic text-sm">Figure 6: Chromatogram showing a stability-indicating UHPLC method for a drug product Stribild oral tablet with four APIs (elvitegravir, cobicistat, emtricitabine, and tenofovir disoproxil fumarate). UHPLC method conditions are shown in the inset. Chromatogram reprinted from reference (13).</p><div class="top-[-100%] block w-[1px] transition-opacity duration-500 ease-in-out opacity-0 overflow-hidden"><img class="m-auto absolute inset-0 max-w-[0%] max-h-[0%] border-[3px] border-solid border-white shadow-[0px_0px_8px_rgba(0,0,0,0.3)] box-border transition ease-in-out duration-500" src="https://cdn.sanity.io/images/0vv8moc6/chroma/d0d0b6bed0948d5667bb7434cdbac9d25cea1f42-2912x1422.jpg?fit=crop&auto=format"/></div></div><style> #image-caption p{ font-size: 12px; max-width: 525px; margin: 0 auto; text-align: center; } </style></div><p class="pb-2"><strong>An Early UHPLC Method Development Case Study of an NCE DS Procedure</strong></p><p class="pb-2">Figures 7a–d shows a sequence of four chromatograms obtained during an early UHPLC method development case study of an NCE DS method, which has several light degradants published in 2007 (9). Figure 7a shows the original 35-min HPLC chromatogram from a client using a phosphate buffer. This mostly isocratic method was not acceptable because a shoulder “hump” was observed on the downslope of the API peak, indicating the presence of a hidden impurity. Figure 7b shows a 5-min broad-gradient column screening study using a 50-mm C18 column showing an equivalent separation of the original HPLC chromatogram. The entire 4-column screens study took 1 h, indicating a polar-embedded phase (Acquity Shield RP18, 50 x 2.1 mm, 1.7-µm) yielded the best separation around the critical region. MPA was changed to an MS-compatible buffer of 20-mM ammonium format at pH 3.7. Figure 7c shows the final 13-min UHPLC method using an Acquity Shield RP18, 100 x 2.1 mm, 1.7-µm, which yielded an improved resolution of three impurities peaks in the critical region. Figure 7d shows the final 20-min “back-translated” HPLC method using an HPLC column (XBridge Shield RP18, 150 x 3.0 mm, 3.5-µm). This process took 2 d, using principles of “geometric-scaling” (23), assisted by a modeling software (DryLab) to ensure that all three light degradants labeled with an asterisk could be resolved. The entire method development project took about 1 week, including the “back-translation” of the UHPLC method into HPLC conditions.</p><p class="pb-2"></p><div class="flex justify-center"><div style="width:30%;float:;max-width:525px;margin:0 auto 1rem;clear:both;cursor:pointer" class=" figure"><div class="flex-none relative text-center"><span style="box-sizing:border-box;display:inline-block;overflow:hidden;width:initial;height:initial;background:none;opacity:1;border:0;margin:0;padding:0;position:relative;max-width:100%"><span style="box-sizing:border-box;display:block;width:initial;height:initial;background:none;opacity:1;border:0;margin:0;padding:0;max-width:100%"><img style="display:block;max-width:100%;width:initial;height:initial;background:none;opacity:1;border:0;margin:0;padding:0" alt="" aria-hidden="true" src="data:image/svg+xml,%3csvg%20xmlns=%27http://www.w3.org/2000/svg%27%20version=%271.1%27%20width=%273270%27%20height=%272186%27/%3e"/></span><img alt="" title="" src="data:image/gif;base64,R0lGODlhAQABAIAAAAAAAP///yH5BAEAAAAALAAAAAABAAEAAAIBRAA7" decoding="async" data-nimg="intrinsic" style="position:absolute;top:0;left:0;bottom:0;right:0;box-sizing:border-box;padding:0;border:none;margin:auto;display:block;width:0;height:0;min-width:100%;max-width:100%;min-height:100%;max-height:100%;object-fit:contain"/><noscript><img alt="" title="" srcSet="/_next/image?url=https%3A%2F%2Fcdn.sanity.io%2Fimages%2F0vv8moc6%2Fchroma%2Fb42b9e0bf3df68b8160a2c428f5e0cd21c8de343-3270x2186.jpg%3Ffit%3Dcrop%26auto%3Dformat&w=3840&q=75 1x" src="/_next/image?url=https%3A%2F%2Fcdn.sanity.io%2Fimages%2F0vv8moc6%2Fchroma%2Fb42b9e0bf3df68b8160a2c428f5e0cd21c8de343-3270x2186.jpg%3Ffit%3Dcrop%26auto%3Dformat&w=3840&q=75" decoding="async" data-nimg="intrinsic" style="position:absolute;top:0;left:0;bottom:0;right:0;box-sizing:border-box;padding:0;border:none;margin:auto;display:block;width:0;height:0;min-width:100%;max-width:100%;min-height:100%;max-height:100%;object-fit:contain" loading="lazy"/></noscript></span></div><p class="text-gray-500 italic text-sm">Figure 7: A case study of the UHPLC method development of a DS method of an NCE with several light degradants. (a) The original 35-min HPLC method using a phosphate buffer at pH 3.1; (b) A 5-min broad-gradient column screening study using a short C18 column; (c) The final 13-min UHPLC method (Acquity Shield RP18, 100 x 2.1 mm, 1.7-μm) yields three impurities peaks in the critical region; (d) The final 20-min “back-translated” HPLC method using an HPLC column (XBridge Shield RP18, 150 x 3.0 mm, 3.5-μm) showing the resolution of three light degradants. </p><div class="top-[-100%] block w-[1px] transition-opacity duration-500 ease-in-out opacity-0 overflow-hidden"><img class="m-auto absolute inset-0 max-w-[0%] max-h-[0%] border-[3px] border-solid border-white shadow-[0px_0px_8px_rgba(0,0,0,0.3)] box-border transition ease-in-out duration-500" src="https://cdn.sanity.io/images/0vv8moc6/chroma/b42b9e0bf3df68b8160a2c428f5e0cd21c8de343-3270x2186.jpg?fit=crop&auto=format"/></div></div><style> #image-caption p{ font-size: 12px; max-width: 525px; margin: 0 auto; text-align: center; } </style></div><p class="pb-2"><strong>A Modernized Universal Generic Method for Multiple NCEs</strong></p><p class="pb-2">Wouldn’t it be nice if we could have a single universal generic gradient method that works for multiple NCEs and most pharmaceutical analyses? The concept appeared to work well for cleaning verification when a 10-min HPLC-UV generic method was found suitable for multiple NCEs in a small-molecule portfolio of an organization in 2012 (30). In 2014, the idea was further extended by applying the latest column technologies (short columns packed with sub-3-µm superficially porous particles (SPP) with improved bonded chemistry) to allow the development of a modernized version of a 2-min generic gradient method operating at optimum conditions with simple mobile phases (11).</p><p class="pb-2">Figure 8a shows the performance of this modernized generic gradient HPLC-UV–MS method in the separation of a 12-component test mix (11). The method has a peak capacity (Pc) of 100, and resolves ten peaks out a mixture of 12 NCEs with good peak shapes and sensitivity with simple mobile phases on both HPLC and UHPLC systems (3700 psi). Best of all, the “standard” 2-min method can be easily adjusted to resolve all twelve NCEs with a run time of 5 min by simple adjustments of gradient conditions (Figure 8b).</p><p class="pb-2"></p><div class="flex justify-center"><div style="width:30%;float:;max-width:525px;margin:0 auto 1rem;clear:both;cursor:pointer" class=" figure"><div class="flex-none relative text-center"><span style="box-sizing:border-box;display:inline-block;overflow:hidden;width:initial;height:initial;background:none;opacity:1;border:0;margin:0;padding:0;position:relative;max-width:100%"><span style="box-sizing:border-box;display:block;width:initial;height:initial;background:none;opacity:1;border:0;margin:0;padding:0;max-width:100%"><img style="display:block;max-width:100%;width:initial;height:initial;background:none;opacity:1;border:0;margin:0;padding:0" alt="" aria-hidden="true" src="data:image/svg+xml,%3csvg%20xmlns=%27http://www.w3.org/2000/svg%27%20version=%271.1%27%20width=%273119%27%20height=%272250%27/%3e"/></span><img alt="" title="" src="data:image/gif;base64,R0lGODlhAQABAIAAAAAAAP///yH5BAEAAAAALAAAAAABAAEAAAIBRAA7" decoding="async" data-nimg="intrinsic" style="position:absolute;top:0;left:0;bottom:0;right:0;box-sizing:border-box;padding:0;border:none;margin:auto;display:block;width:0;height:0;min-width:100%;max-width:100%;min-height:100%;max-height:100%;object-fit:contain"/><noscript><img alt="" title="" srcSet="/_next/image?url=https%3A%2F%2Fcdn.sanity.io%2Fimages%2F0vv8moc6%2Fchroma%2F661ed82f6531610d6f4e745ae7746f9d7a2f711b-3119x2250.jpg%3Ffit%3Dcrop%26auto%3Dformat&w=3840&q=75 1x" src="/_next/image?url=https%3A%2F%2Fcdn.sanity.io%2Fimages%2F0vv8moc6%2Fchroma%2F661ed82f6531610d6f4e745ae7746f9d7a2f711b-3119x2250.jpg%3Ffit%3Dcrop%26auto%3Dformat&w=3840&q=75" decoding="async" data-nimg="intrinsic" style="position:absolute;top:0;left:0;bottom:0;right:0;box-sizing:border-box;padding:0;border:none;margin:auto;display:block;width:0;height:0;min-width:100%;max-width:100%;min-height:100%;max-height:100%;object-fit:contain" loading="lazy"/></noscript></span></div><p class="text-gray-500 italic text-sm">Figure 8: (a) The separation of a 12-NCE mixture using the proposed 2-min universal gradient reversed-phase chromatography method using a sub-3-μm superficially pourous particle column. (b) A chromatogram depicting the achievement of near-baseline resolution of all 12 NCEs in the test mixture by adjustments of gradient conditions using the same bonded phase in a 2.1 mm column format. Each peak is designated by its code name, retention time in minutes, and (M+H) +1 parent ion. Reprinted from reference 11.</p><div class="top-[-100%] block w-[1px] transition-opacity duration-500 ease-in-out opacity-0 overflow-hidden"><img class="m-auto absolute inset-0 max-w-[0%] max-h-[0%] border-[3px] border-solid border-white shadow-[0px_0px_8px_rgba(0,0,0,0.3)] box-border transition ease-in-out duration-500" src="https://cdn.sanity.io/images/0vv8moc6/chroma/661ed82f6531610d6f4e745ae7746f9d7a2f711b-3119x2250.jpg?fit=crop&auto=format"/></div></div><style> #image-caption p{ font-size: 12px; max-width: 525px; margin: 0 auto; text-align: center; } </style></div><p class="pb-2">The rationales in the selection of columns, mobile phases, and operating conditions are explained in the 2016 reference (11). This reference also provides several case studies that this generic method can be applied to stability-indicating applications by quick adjustments of gradient conditions (using longer <em>t</em>G and multi-segment gradient) to obtain reasonable initial method conditions. The next steps can be a column or mobile-phase screening and the use of a longer column to arrive at the final regulatory method conditions.</p><p class="pb-2">In summary, a generic gradient method using a short column operating at optimum conditions shown in Figure 8a (for example, C18, 50 mmx 3.0 mm i.d., 2.7-µm SPP, 5 - 60% acetonitrile in 2 min at 1 mL/min) is capable of delivering peak capacities (Pc) of 100-300 in 2 to 10 minutes (2,31–32). The generic method approach works well for cleaning verification of multiple NCEs and provides a useful starting point in the development of stability-indicating analytical procedures.</p><p class="pb-2"><strong>Method Content, Execution, and Life Cycle Management</strong></p><p class="pb-2">We devote the final section to discussing the essential elements in a well-written HPLC method (33), guidance in method execution to generate more reliable stability data, and the concept of life cycle management of analytical procedures (34).</p><p class="pb-2"><strong>Method Content and Essential Elements in an Analytical Procedure</strong></p><p class="pb-2">A well-written analytical procedure with all essential elements is critical for its successful execution of the laboratory. Table IV lists these essential elements for late-stage methods, excerpted from a recent U.S. FDA guidance document (33).</p><p class="pb-2"></p><div class="flex justify-center"><div style="width:30%;float:;max-width:525px;margin:0 auto 1rem;clear:both;cursor:pointer" class=" figure"><div class="flex-none relative text-center"><span style="box-sizing:border-box;display:inline-block;overflow:hidden;width:initial;height:initial;background:none;opacity:1;border:0;margin:0;padding:0;position:relative;max-width:100%"><span style="box-sizing:border-box;display:block;width:initial;height:initial;background:none;opacity:1;border:0;margin:0;padding:0;max-width:100%"><img style="display:block;max-width:100%;width:initial;height:initial;background:none;opacity:1;border:0;margin:0;padding:0" alt="" aria-hidden="true" src="data:image/svg+xml,%3csvg%20xmlns=%27http://www.w3.org/2000/svg%27%20version=%271.1%27%20width=%27647%27%20height=%27702%27/%3e"/></span><img alt="" title="" src="data:image/gif;base64,R0lGODlhAQABAIAAAAAAAP///yH5BAEAAAAALAAAAAABAAEAAAIBRAA7" decoding="async" data-nimg="intrinsic" style="position:absolute;top:0;left:0;bottom:0;right:0;box-sizing:border-box;padding:0;border:none;margin:auto;display:block;width:0;height:0;min-width:100%;max-width:100%;min-height:100%;max-height:100%;object-fit:contain"/><noscript><img alt="" title="" srcSet="/_next/image?url=https%3A%2F%2Fcdn.sanity.io%2Fimages%2F0vv8moc6%2Fchroma%2F8f3b4e814c5fd646ada6cdcc5ced46d1372cf755-647x702.jpg%3Ffit%3Dcrop%26auto%3Dformat&w=750&q=75 1x, /_next/image?url=https%3A%2F%2Fcdn.sanity.io%2Fimages%2F0vv8moc6%2Fchroma%2F8f3b4e814c5fd646ada6cdcc5ced46d1372cf755-647x702.jpg%3Ffit%3Dcrop%26auto%3Dformat&w=1920&q=75 2x" src="/_next/image?url=https%3A%2F%2Fcdn.sanity.io%2Fimages%2F0vv8moc6%2Fchroma%2F8f3b4e814c5fd646ada6cdcc5ced46d1372cf755-647x702.jpg%3Ffit%3Dcrop%26auto%3Dformat&w=1920&q=75" decoding="async" data-nimg="intrinsic" style="position:absolute;top:0;left:0;bottom:0;right:0;box-sizing:border-box;padding:0;border:none;margin:auto;display:block;width:0;height:0;min-width:100%;max-width:100%;min-height:100%;max-height:100%;object-fit:contain" loading="lazy"/></noscript></span></div><div class="top-[-100%] block w-[1px] transition-opacity duration-500 ease-in-out opacity-0 overflow-hidden"><img class="m-auto absolute inset-0 max-w-[0%] max-h-[0%] border-[3px] border-solid border-white shadow-[0px_0px_8px_rgba(0,0,0,0.3)] box-border transition ease-in-out duration-500" src="https://cdn.sanity.io/images/0vv8moc6/chroma/8f3b4e814c5fd646ada6cdcc5ced46d1372cf755-647x702.jpg?fit=crop&auto=format"/></div></div><style> #image-caption p{ font-size: 12px; max-width: 525px; margin: 0 auto; text-align: center; } </style></div><p class="pb-2">In addition, it is also essential to include as many helpful details in the written method as the analyst will need to successfully execute the method. The method should include example chromatograms (both full- and expanded-scale of a blank, retention marker solution or SSTsolution, standard solution, and a typical sample solution), safety precautions, a table of RRT and RRF if available (2), and method history with reasons for revisions.</p><p class="pb-2"></p><p class="pb-2"><strong>Strategies for Method Execution to Generate Reliable Stability Data</strong></p><p class="pb-2">A well-developed and written analytical procedure with full validation and vigorous transfer process is the cornerstone for effective method execution. Understanding the chemistry of the NCE, the physicochemical characteristics of the molecule (such as photosensitivity, hygroscopicity, forms, reactivity, and chirality) and their effects on the stability profile of the DS and DP is crucial. The judicious use of forced degradation and accelerated stability studies, and predictive software models (7) can often reduce the need for conducting more stability studies.</p><p class="pb-2">Ideally, the CMC analytical team lead, having intimate knowledge of the drug candidate, should be responsible for the method development and conducting the initial release testing and stability study of the first clinical batches. This work allows a better understanding of the stability profile of the NCE and the nuances in method execution before outsourcing stability studies to external contract organizations. In general, the contract manufacturing organizations (CMOs) selected for the large-scale production of clinical trial materials (CTMs), tend to be preferred partners for conducting stability studies, because they have a higher stake in the success of the development project. It is customary to include shipment of the SST retention marker solutions to the transferred laboratories to lessen the occurrence of peak misidentification caused by retention time peak shifts and potential stability data issues down the line.</p><p class="pb-2"><strong>Life Cycle Management of Analytical Procedures</strong></p><p class="pb-2">The life cycle management approach can benefit a laboratory and the drug developer by improving the performance of methods, reducing analytical uncertainties such as out-of-specification (OOS) and out-of-trend (OOT) results, and improving the success of the method transfers.</p><p class="pb-2">Life cycle management of analytical procedures is an integrated method design, development, and performance characterization strategy based on a structured and systematic approach using concepts of QbD similar to those applied to new drug development (24,34). This approach should be phase appropriate during the early drug substance method development to the final fully validated late-stage drug product methodologies. The strategy starts with the definition of an analytical target profile (ATP)–where the requirements of the analytical procedure (what to measure, method and sample type, separation criteria and performance requirements) for assessing the critical quality attributes (CQAs) of the drug substance and the drug products are described. The three stages of the life cycle are:</p><p class="pb-2"><strong>Stage 1: Method Design and Development</strong></p><p class="pb-2">This stage includes an understanding of the variability of the method, risk assessments, and proposed control strategy for critical method parameters (CMPs) that may pose a risk to consistently achieving method requirements.</p><p class="pb-2"><strong>Stage 2: Method Performance Qualification</strong></p><p class="pb-2">The method, with the proposed control strategy, is qualified to ensure it meets its requirements consistently. This stage includes the method validation process and can be phase appropriate depending on the stage of development.</p><p class="pb-2"><strong>Stage 3: Continued Method Performance Optimization or Verification</strong></p><p class="pb-2">This stage includes monitoring the performance after the method is placed into routine QC use by using control samples and charts as well as evaluation and continuous improvements of the method. The results of method transfer can be part of the performance verification process.</p><p class="pb-2"><strong>Summary and Conclusions</strong></p><p class="pb-2">This paper provides an overview of the fundamentals and best practices in the development of stability-indicating methods for pharmaceuticals. It describes the traditional five-step method development approach, as well as modern trends, easier approaches, and software tools for expediting the process. The regulatory guidance on a well-written method, strategy for efficient method execution, and life cycle management of analytical procedures are also discussed.</p><p class="pb-2"><strong>Acknowledgments</strong></p><p class="pb-2">The authors express their gratitude to the following colleagues for their time and efforts to provide timely reviews of the manuscript to improve content accuracy and clarity: Tao Jiang of Mallinckrodt; Anissa Wong and Chris Foti of Gilead Sciences; Mike Shifflet of Johnson and Johnson Consumer Health Care; He Meng of Sanofi; Adrijana Torbovska of Farmahem; Alice Krumenaker of TW Metals, LLC; Mark Shapiro of MCS Pharma Consulting; Szabolcs Fekete of U. Geneva; Deidre Cabooter of KU Leuven; Tamara Andreoli of Medinova AG, Schweiz; Michael DeHart of CMP Pharma; Marc Foster of Mythctest.</p><p class="pb-2"><strong>References</strong></p><ol class="my-2"><li class="list-decimal ml-8">L.R. Snyder, J.J. Kirkland, and J.L. Glajch, <em>Practical HPLC Method Development</em> (John Wiley & Sons, Hoboken, New Jersey, 1997), Chapters 1–2 and 8–9.</li><li class="list-decimal ml-8">M.W. Dong, <em>HPLC and UHPLC for Practicing Scientists,</em> (John Wiley & Sons. Hoboken, New Jersey, 2nd Edition, 2019), Chapters 2–6 and 9–11.</li><li class="list-decimal ml-8">S. Ahuja and M.W. Dong (Eds.), <em>Handbook of Pharmaceutical Analysis by HPLC</em> (Elsevier. Amsterdam, Netherlands, 2005), Chapters 5 and 6.</li><li class="list-decimal ml-8">L.R. Snyder and J.W. Dolan, <em>High-Performance Gradient Elution: The Practical Application of the Linear-Solvent-Strength Model</em>, (Wiley-Interscience, Hoboken, New Jersey, 2007), Chapter 3.</li><li class="list-decimal ml-8">Y.V. Kazakevich and R. LoBrutto (Eds.), <em>HPLC for Pharmaceutical Scientists</em> (John Wiley & Sons, Hoboken, New Jersey, 2007), Chapter 8.</li><li class="list-decimal ml-8">K. 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Molnár, and K. Ganzier, <em>J. Chromatogr. A </em><strong>1216</strong>(45), 7816–23 (2009).</li><li class="list-decimal ml-8">E.F. Hewitt, P. Lukulay, and S. Galushko, <em>J. Chromatogr. A </em><strong>1107</strong>(1–2), 79–87 (2006).</li><li class="list-decimal ml-8">R.P. Verseput and J. A. Turpin, <em>Chromatography Today</em>, Aug 26, 2015.</li><li class="list-decimal ml-8">M. Wong, B. Murphy, J. H. Pease, and M. W. Dong, <em>LCGC North Am. </em><strong>33</strong>(6), 402 (2015).</li><li class="list-decimal ml-8">M.W. Dong, <em>LCGC North Am. </em><strong>34</strong>(8), 540–545 (2016).</li><li class="list-decimal ml-8">M.W. Dong, E.X. Zhao, D.T. Yazzie, C. C. Gu, and J.D. Pellett, <em>Amer. Pharm. Rev. </em><strong>15</strong>(6), 10–17 (2012).</li><li class="list-decimal ml-8">S. Fekete, D. Guillarme, and M.W. Dong, <em>LCGC North Am. </em><strong>32</strong>(6), 420–433 (2014).</li><li class="list-decimal ml-8">M.W. Dong and B.E. Boyes, <em>LCGC North Am</em>. <strong>36</strong>(10), 752–767 (2018).</li><li class="list-decimal ml-8"><em>Analytical Procedure and Method Validation for Drugs and Biologics: Guidance for Industry</em> (US FDA, CDER and CBER, Pharma Quality/CMC, Silver Spring, Maryland, (2015).</li><li class="list-decimal ml-8">M.K. Parr and A.H. Schmidt, <em>J. Pharm. Biomed. Anal.</em> <strong>147,</strong> 506–518 (2018).</li></ol><p class="pb-2"></p><p class="pb-2"></p><div class=""><div style="width:30%;float:left;max-width:525px;margin:0 1.5rem 1.5rem 0;clear:both;cursor:pointer" class=" figure"><div class="flex-none relative text-center"><span style="box-sizing:border-box;display:inline-block;overflow:hidden;width:initial;height:initial;background:none;opacity:1;border:0;margin:0;padding:0;position:relative;max-width:100%"><span style="box-sizing:border-box;display:block;width:initial;height:initial;background:none;opacity:1;border:0;margin:0;padding:0;max-width:100%"><img style="display:block;max-width:100%;width:initial;height:initial;background:none;opacity:1;border:0;margin:0;padding:0" alt="" aria-hidden="true" src="data:image/svg+xml,%3csvg%20xmlns=%27http://www.w3.org/2000/svg%27%20version=%271.1%27%20width=%27140%27%20height=%27160%27/%3e"/></span><img alt="" title="" src="data:image/gif;base64,R0lGODlhAQABAIAAAAAAAP///yH5BAEAAAAALAAAAAABAAEAAAIBRAA7" decoding="async" data-nimg="intrinsic" style="position:absolute;top:0;left:0;bottom:0;right:0;box-sizing:border-box;padding:0;border:none;margin:auto;display:block;width:0;height:0;min-width:100%;max-width:100%;min-height:100%;max-height:100%;object-fit:contain"/><noscript><img alt="" title="" srcSet="/_next/image?url=https%3A%2F%2Fcdn.sanity.io%2Fimages%2F0vv8moc6%2Fchroma%2F59bf1d6c030b006a2f479ada9465bbc0967175b4-140x160.jpg%3Ffit%3Dcrop%26auto%3Dformat&w=256&q=75 1x, /_next/image?url=https%3A%2F%2Fcdn.sanity.io%2Fimages%2F0vv8moc6%2Fchroma%2F59bf1d6c030b006a2f479ada9465bbc0967175b4-140x160.jpg%3Ffit%3Dcrop%26auto%3Dformat&w=384&q=75 2x" src="/_next/image?url=https%3A%2F%2Fcdn.sanity.io%2Fimages%2F0vv8moc6%2Fchroma%2F59bf1d6c030b006a2f479ada9465bbc0967175b4-140x160.jpg%3Ffit%3Dcrop%26auto%3Dformat&w=384&q=75" decoding="async" data-nimg="intrinsic" style="position:absolute;top:0;left:0;bottom:0;right:0;box-sizing:border-box;padding:0;border:none;margin:auto;display:block;width:0;height:0;min-width:100%;max-width:100%;min-height:100%;max-height:100%;object-fit:contain" loading="lazy"/></noscript></span></div><div class="top-[-100%] block w-[1px] transition-opacity duration-500 ease-in-out opacity-0 overflow-hidden"><img class="m-auto absolute inset-0 max-w-[0%] max-h-[0%] border-[3px] border-solid border-white shadow-[0px_0px_8px_rgba(0,0,0,0.3)] box-border transition ease-in-out duration-500" src="https://cdn.sanity.io/images/0vv8moc6/chroma/59bf1d6c030b006a2f479ada9465bbc0967175b4-140x160.jpg?fit=crop&auto=format"/></div></div><style> #image-caption p{ font-size: 12px; max-width: 525px; margin: 0 auto; text-align: center; } </style></div><p class="pb-2"><strong>Michael W. Dong </strong>is a principal of MWD Consulting, which provides training and consulting services in HPLC and UHPLC, method improvements, pharmaceutical analysis, and drug quality. He was formerly a Senior Scientist at Genentech, Research Fellow at Purdue Pharma, and Senior Staff Scientist at Applied Biosystems/PerkinElmer. He holds a PhD in Analytical Chemistry from City University of New York. He has more than 100 publications and a best-selling book in chromatography. He is an editorial advisory board member of <em>LCGC North America </em>and the Chinese American Chromatography Association. Direct correspondence to: <a rel="nofollow noreferrer noopener" target="_blank" href="mailto:LCGCedit@ubm.com">LCGCedit@ubm.com</a> </p><p class="pb-2"></p><p class="pb-2"></p><div class=""><div style="width:30%;float:left;max-width:525px;margin:0 1.5rem 1.5rem 0;clear:both;cursor:pointer" class=" figure"><div class="flex-none relative text-center"><span style="box-sizing:border-box;display:inline-block;overflow:hidden;width:initial;height:initial;background:none;opacity:1;border:0;margin:0;padding:0;position:relative;max-width:100%"><span style="box-sizing:border-box;display:block;width:initial;height:initial;background:none;opacity:1;border:0;margin:0;padding:0;max-width:100%"><img style="display:block;max-width:100%;width:initial;height:initial;background:none;opacity:1;border:0;margin:0;padding:0" alt="" aria-hidden="true" src="data:image/svg+xml,%3csvg%20xmlns=%27http://www.w3.org/2000/svg%27%20version=%271.1%27%20width=%271581%27%20height=%272004%27/%3e"/></span><img alt="" title="" src="data:image/gif;base64,R0lGODlhAQABAIAAAAAAAP///yH5BAEAAAAALAAAAAABAAEAAAIBRAA7" decoding="async" data-nimg="intrinsic" style="position:absolute;top:0;left:0;bottom:0;right:0;box-sizing:border-box;padding:0;border:none;margin:auto;display:block;width:0;height:0;min-width:100%;max-width:100%;min-height:100%;max-height:100%;object-fit:contain"/><noscript><img alt="" title="" srcSet="/_next/image?url=https%3A%2F%2Fcdn.sanity.io%2Fimages%2F0vv8moc6%2Fchroma%2F83b48b63dc8937675e4cba4170934ac5c4a62875-1581x2004.jpg%3Ffit%3Dcrop%26auto%3Dformat&w=1920&q=75 1x, /_next/image?url=https%3A%2F%2Fcdn.sanity.io%2Fimages%2F0vv8moc6%2Fchroma%2F83b48b63dc8937675e4cba4170934ac5c4a62875-1581x2004.jpg%3Ffit%3Dcrop%26auto%3Dformat&w=3840&q=75 2x" src="/_next/image?url=https%3A%2F%2Fcdn.sanity.io%2Fimages%2F0vv8moc6%2Fchroma%2F83b48b63dc8937675e4cba4170934ac5c4a62875-1581x2004.jpg%3Ffit%3Dcrop%26auto%3Dformat&w=3840&q=75" decoding="async" data-nimg="intrinsic" style="position:absolute;top:0;left:0;bottom:0;right:0;box-sizing:border-box;padding:0;border:none;margin:auto;display:block;width:0;height:0;min-width:100%;max-width:100%;min-height:100%;max-height:100%;object-fit:contain" loading="lazy"/></noscript></span></div><div class="top-[-100%] block w-[1px] transition-opacity duration-500 ease-in-out opacity-0 overflow-hidden"><img class="m-auto absolute inset-0 max-w-[0%] max-h-[0%] border-[3px] border-solid border-white shadow-[0px_0px_8px_rgba(0,0,0,0.3)] box-border transition ease-in-out duration-500" src="https://cdn.sanity.io/images/0vv8moc6/chroma/83b48b63dc8937675e4cba4170934ac5c4a62875-1581x2004.jpg?fit=crop&auto=format"/></div></div><style> #image-caption p{ font-size: 12px; max-width: 525px; margin: 0 auto; text-align: center; } </style></div><p class="pb-2"><strong>Kim Huynh-Ba </strong>is the managing director of Pharmalytik LLC. (www.pharmalytik.com), which provides consulting services in stability sciences, quality management systems, and analytical development. She is an Adjunct Professor at Temple University-School of Pharmacy and Illinois Institute of Technology (IIT). Kim is a member of the US Pharmacopeia’s Council of Expert, chairing the Chemical Medicines Monograph IV Expert Committee, USP Good Documentation Practices Expert Panel, USP Organic Impurities of Drug Substance, and Drug Products Expert Panel. She is on the editorial board of the AAPS Open, the Journal of GXP Compliance, and the Journal of Validation Technology. Kim authored ~30 publications and edited two books on stability testing.</p><p class="pb-2"></p><p class="pb-2"></p><div class=""><div style="width:30%;float:left;max-width:525px;margin:0 1.5rem 1.5rem 0;clear:both;cursor:pointer" class=" figure"><div class="flex-none relative text-center"><span style="box-sizing:border-box;display:inline-block;overflow:hidden;width:initial;height:initial;background:none;opacity:1;border:0;margin:0;padding:0;position:relative;max-width:100%"><span style="box-sizing:border-box;display:block;width:initial;height:initial;background:none;opacity:1;border:0;margin:0;padding:0;max-width:100%"><img style="display:block;max-width:100%;width:initial;height:initial;background:none;opacity:1;border:0;margin:0;padding:0" alt="" aria-hidden="true" src="data:image/svg+xml,%3csvg%20xmlns=%27http://www.w3.org/2000/svg%27%20version=%271.1%27%20width=%271812%27%20height=%272312%27/%3e"/></span><img alt="" title="" src="data:image/gif;base64,R0lGODlhAQABAIAAAAAAAP///yH5BAEAAAAALAAAAAABAAEAAAIBRAA7" decoding="async" data-nimg="intrinsic" style="position:absolute;top:0;left:0;bottom:0;right:0;box-sizing:border-box;padding:0;border:none;margin:auto;display:block;width:0;height:0;min-width:100%;max-width:100%;min-height:100%;max-height:100%;object-fit:contain"/><noscript><img alt="" title="" srcSet="/_next/image?url=https%3A%2F%2Fcdn.sanity.io%2Fimages%2F0vv8moc6%2Fchroma%2F56436d03c6703ac138ace4a3cad2cff4e8d44561-1812x2312.jpg%3Ffit%3Dcrop%26auto%3Dformat&w=1920&q=75 1x, /_next/image?url=https%3A%2F%2Fcdn.sanity.io%2Fimages%2F0vv8moc6%2Fchroma%2F56436d03c6703ac138ace4a3cad2cff4e8d44561-1812x2312.jpg%3Ffit%3Dcrop%26auto%3Dformat&w=3840&q=75 2x" src="/_next/image?url=https%3A%2F%2Fcdn.sanity.io%2Fimages%2F0vv8moc6%2Fchroma%2F56436d03c6703ac138ace4a3cad2cff4e8d44561-1812x2312.jpg%3Ffit%3Dcrop%26auto%3Dformat&w=3840&q=75" decoding="async" data-nimg="intrinsic" style="position:absolute;top:0;left:0;bottom:0;right:0;box-sizing:border-box;padding:0;border:none;margin:auto;display:block;width:0;height:0;min-width:100%;max-width:100%;min-height:100%;max-height:100%;object-fit:contain" loading="lazy"/></noscript></span></div><div class="top-[-100%] block w-[1px] transition-opacity duration-500 ease-in-out opacity-0 overflow-hidden"><img class="m-auto absolute inset-0 max-w-[0%] max-h-[0%] border-[3px] border-solid border-white shadow-[0px_0px_8px_rgba(0,0,0,0.3)] box-border transition ease-in-out duration-500" src="https://cdn.sanity.io/images/0vv8moc6/chroma/56436d03c6703ac138ace4a3cad2cff4e8d44561-1812x2312.jpg?fit=crop&auto=format"/></div></div><style> #image-caption p{ font-size: 12px; max-width: 525px; margin: 0 auto; text-align: center; } </style></div><p class="pb-2"><strong>Joshua T. Ayers </strong>is the Principal Consultant at ASQ Solutions, LLC, which provides analytical, stability, and quality consulting services to the pharmaceutical industry. He has worked on several early and late-stage development projects and marketed products. He has managed analytical laboratories and stability programs for large pharmaceutical companies. Joshua holds a Ph.D. in Medicinal Chemistry from the College of Pharmacy, University of Kentucky. He has authored more than 20 publications and currently sits on the AAPS Stability Community.</p><p class="pb-2"></p></div></div><div class="flex items-center lg:w-3/4 mb-4 pb-12"><div class="flex sm:inline"><a target="_blank" class="mr-[5px] md:mr-2 p-[.56rem] border rounded-md bg-primary text-white" href="https://cdn.sanity.io/files/0vv8moc6/chroma/f562afa926baa1c61c935270836a3374f513bb14.pdf/LCGC_NAmerica_August2020%20(1).pdf">Download Issue PDF</a></div></div><div class="mb-6"><div class="jsx-19ede9f0a5a45918 py-4 relative bg-primary md:px-8 pl-2 -ml-6 xs:ml-0 w-screen xs:w-full mb-4 "><div class="jsx-19ede9f0a5a45918 px-4 sm:px-0"><div class="jsx-19ede9f0a5a45918 text-white text-2xl md:text-3xl pb-2 md:pb-1">Articles in this issue</div><hr class="jsx-19ede9f0a5a45918 -mr-2"/></div><div style="scroll-snap-type:none" class="jsx-19ede9f0a5a45918 flex items-start overflow-x-auto space-x-4 py-4 relative mx-auto w-full pl-4'"><div class="jsx-19ede9f0a5a45918 mr-12 pl-4"><img 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ml-2 flex-1"><p class="font-bold text-[1rem] pl-4 text-undefined" style="font-size:1rem"><a href="/view/best-of-the-week-eas-2024-awardees-oligonucleotides-in-drug-development-and-more?utm_source=www.chromatographyonline.com&utm_medium=relatedContent">Best of the Week: EAS 2024 Awardees, Oligonucleotides in Drug Development, and More</a></p><div class=" pl-4"><a class="text-sm text-sky-800" href="/authors/aaron-acevedo">Aaron Acevedo</a></div><a href="/view/best-of-the-week-eas-2024-awardees-oligonucleotides-in-drug-development-and-more?utm_source=www.chromatographyonline.com&utm_medium=relatedContent"><span class="text-sm text-gray-500 pl-4">November 22nd 2024</span><div><span class="px-2 py-1 ml-4 text-xs text-white border bg-primary italic">Article</span></div><div class="mt-2 ml-4"></div><div class="flex flex-row gap-2"></div><p class=" mt-4 text-gray-800 pl-4">Here is some of the most popular content posted on LCGC International this week.</p><div class="pl-4"></div></a><div class="flex flex-col sm:flex-row pl-2 mt-4"></div></div></div></div></div></div><div class="mb-4 w-full h-full"><hr class="mt-1 w-full " style="border-top-width:1px;border-top-color:#F3F4F6"/><div class="w-full h-full" style="box-shadow:0px 0px 0 0 rgb(194, 194, 194, 1)"><div class="w-full md:w-auto md:flex md:flex-col md:items-center lg:items-start lg:flex-row mb-4 mt-3 p-4"><div class="flex flex-1 md:col-span-2 " style="background-color:transparent;border-color:#F3F4F6;border-width:0;border-top-left-radius:0rem;border-top-right-radius:0rem;border-bottom-left-radius:0rem;border-bottom-right-radius:0rem"><a class=" md:flex-none w-full md:w-48 mt-2" href="/view/in-bruges-hplc-2025?utm_source=www.chromatographyonline.com&utm_medium=relatedContent"><div class=""><span style="box-sizing:border-box;display:block;overflow:hidden;width:initial;height:initial;background:none;opacity:1;border:0;margin:0;padding:0;position:relative"><span style="box-sizing:border-box;display:block;width:initial;height:initial;background:none;opacity:1;border:0;margin:0;padding:0;padding-top:66.66666666666666%"></span><img alt="Canals of Bruges, Belgium | Image Credit: © gqxue - stock.adobe.com" title="Canals of Bruges, Belgium | Image Credit: © gqxue - stock.adobe.com" src="data:image/gif;base64,R0lGODlhAQABAIAAAAAAAP///yH5BAEAAAAALAAAAAABAAEAAAIBRAA7" decoding="async" data-nimg="responsive" class="shrink-0" style="border-top-left-radius:0rem;border-top-right-radius:0rem;border-bottom-left-radius:0rem;border-bottom-right-radius:0rem;position:absolute;top:0;left:0;bottom:0;right:0;box-sizing:border-box;padding:0;border:none;margin:auto;display:block;width:0;height:0;min-width:100%;max-width:100%;min-height:100%;max-height:100%"/><noscript><img alt="Canals of Bruges, Belgium | Image Credit: © gqxue - stock.adobe.com" title="Canals of Bruges, Belgium | Image Credit: © gqxue - stock.adobe.com" sizes="100vw" srcSet="/_next/image?url=https%3A%2F%2Fcdn.sanity.io%2Fimages%2F0vv8moc6%2Fchroma%2F0aa31539c817c805fe12018157a1e8171b6150fa-3600x2400.jpg%3Ffit%3Dcrop%26auto%3Dformat&w=640&q=75 640w, /_next/image?url=https%3A%2F%2Fcdn.sanity.io%2Fimages%2F0vv8moc6%2Fchroma%2F0aa31539c817c805fe12018157a1e8171b6150fa-3600x2400.jpg%3Ffit%3Dcrop%26auto%3Dformat&w=750&q=75 750w, /_next/image?url=https%3A%2F%2Fcdn.sanity.io%2Fimages%2F0vv8moc6%2Fchroma%2F0aa31539c817c805fe12018157a1e8171b6150fa-3600x2400.jpg%3Ffit%3Dcrop%26auto%3Dformat&w=828&q=75 828w, /_next/image?url=https%3A%2F%2Fcdn.sanity.io%2Fimages%2F0vv8moc6%2Fchroma%2F0aa31539c817c805fe12018157a1e8171b6150fa-3600x2400.jpg%3Ffit%3Dcrop%26auto%3Dformat&w=1080&q=75 1080w, /_next/image?url=https%3A%2F%2Fcdn.sanity.io%2Fimages%2F0vv8moc6%2Fchroma%2F0aa31539c817c805fe12018157a1e8171b6150fa-3600x2400.jpg%3Ffit%3Dcrop%26auto%3Dformat&w=1200&q=75 1200w, 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style="border-top-left-radius:0rem;border-top-right-radius:0rem;border-bottom-left-radius:0rem;border-bottom-right-radius:0rem;position:absolute;top:0;left:0;bottom:0;right:0;box-sizing:border-box;padding:0;border:none;margin:auto;display:block;width:0;height:0;min-width:100%;max-width:100%;min-height:100%;max-height:100%" class="shrink-0" loading="lazy"/></noscript></span></div></a><div class="flex-auto w-[200%] md:w-auto ml-2 flex-1"><p class="font-bold text-[1rem] pl-4 text-undefined" style="font-size:1rem"><a href="/view/in-bruges-hplc-2025?utm_source=www.chromatographyonline.com&utm_medium=relatedContent">In Bruges: HPLC 2025</a></p><div class=" pl-4"><a class="text-sm text-sky-800" href="/authors/gert-desmet">Gert Desmet</a><span class="mr-1 ml-[1px]">;</span><a class="text-sm text-sky-800" href="/authors/deirdre-cabooter">Deirdre Cabooter</a><span class="mr-1 ml-[1px]">;</span><a class="text-sm text-sky-800" href="/authors/frederic-lynen">Frédéric Lynen</a><span class="mr-1 ml-[1px]">;</span><a class="text-sm text-sky-800" href="/authors/sebastiaan-eeltink">Sebastiaan Eeltink</a><span class="mr-1 ml-[1px]">;</span><a class="text-sm text-sky-800" href="/authors/ken-broeckhoven">Ken Broeckhoven</a></div><a href="/view/in-bruges-hplc-2025?utm_source=www.chromatographyonline.com&utm_medium=relatedContent"><span class="text-sm text-gray-500 pl-4">November 13th 2024</span><div><span class="px-2 py-1 ml-4 text-xs text-white border bg-primary italic">Article</span></div><div class="mt-2 ml-4"></div><div class="flex flex-row gap-2"></div><p class=" mt-4 text-gray-800 pl-4">The 54th International Symposium on High Performance Liquid Phase Separations and Related Techniques (HPLC 2025) will be held from Sunday through Thursday, June 15-19, 2025, in Bruges, Belgium.</p><div class="pl-4"></div></a><div class="flex flex-col sm:flex-row pl-2 mt-4"></div></div></div></div></div></div><div class="mb-4 w-full h-full"><hr class="mt-1 w-full " style="border-top-width:1px;border-top-color:#F3F4F6"/><div class="flex md:hidden justify-center items-center"></div><div class="w-full h-full" style="box-shadow:0px 0px 0 0 rgb(194, 194, 194, 1)"><div class="w-full md:w-auto md:flex md:flex-col md:items-center lg:items-start lg:flex-row mb-4 mt-3 p-4"><div class="flex flex-1 md:col-span-2 " style="background-color:transparent;border-color:#F3F4F6;border-width:0;border-top-left-radius:0rem;border-top-right-radius:0rem;border-bottom-left-radius:0rem;border-bottom-right-radius:0rem"><a class=" md:flex-none w-full md:w-48 mt-2" href="/view/rapid-quantitative-analysis-of-ethylene-oxide-and-1-4-dioxane-in-polymeric-excipients-using-sift-mass-spectrometry?utm_source=www.chromatographyonline.com&utm_medium=relatedContent"><div class=""><span style="box-sizing:border-box;display:block;overflow:hidden;width:initial;height:initial;background:none;opacity:1;border:0;margin:0;padding:0;position:relative"><span style="box-sizing:border-box;display:block;width:initial;height:initial;background:none;opacity:1;border:0;margin:0;padding:0;padding-top:66.66666666666666%"></span><img alt="Molecule of ethylene oxide, ball-and-stick molecular model. Scientific 3d rendering | Image Credit: © Alexey Novikov - stock.adobe.com" title="Molecule of ethylene oxide, ball-and-stick molecular model. Scientific 3d rendering | Image Credit: © Alexey Novikov - stock.adobe.com" src="data:image/gif;base64,R0lGODlhAQABAIAAAAAAAP///yH5BAEAAAAALAAAAAABAAEAAAIBRAA7" decoding="async" data-nimg="responsive" class="shrink-0" style="border-top-left-radius:0rem;border-top-right-radius:0rem;border-bottom-left-radius:0rem;border-bottom-right-radius:0rem;position:absolute;top:0;left:0;bottom:0;right:0;box-sizing:border-box;padding:0;border:none;margin:auto;display:block;width:0;height:0;min-width:100%;max-width:100%;min-height:100%;max-height:100%"/><noscript><img alt="Molecule of ethylene oxide, ball-and-stick molecular model. Scientific 3d rendering | Image Credit: © Alexey Novikov - stock.adobe.com" title="Molecule of ethylene oxide, ball-and-stick molecular model. Scientific 3d rendering | Image Credit: © Alexey Novikov - stock.adobe.com" sizes="100vw" srcSet="/_next/image?url=https%3A%2F%2Fcdn.sanity.io%2Fimages%2F0vv8moc6%2Fchroma%2F3145743408cce26e88e6381a7320ac324bff3abb-6000x4000.jpg%3Ffit%3Dcrop%26auto%3Dformat&w=640&q=75 640w, /_next/image?url=https%3A%2F%2Fcdn.sanity.io%2Fimages%2F0vv8moc6%2Fchroma%2F3145743408cce26e88e6381a7320ac324bff3abb-6000x4000.jpg%3Ffit%3Dcrop%26auto%3Dformat&w=750&q=75 750w, /_next/image?url=https%3A%2F%2Fcdn.sanity.io%2Fimages%2F0vv8moc6%2Fchroma%2F3145743408cce26e88e6381a7320ac324bff3abb-6000x4000.jpg%3Ffit%3Dcrop%26auto%3Dformat&w=828&q=75 828w, /_next/image?url=https%3A%2F%2Fcdn.sanity.io%2Fimages%2F0vv8moc6%2Fchroma%2F3145743408cce26e88e6381a7320ac324bff3abb-6000x4000.jpg%3Ffit%3Dcrop%26auto%3Dformat&w=1080&q=75 1080w, /_next/image?url=https%3A%2F%2Fcdn.sanity.io%2Fimages%2F0vv8moc6%2Fchroma%2F3145743408cce26e88e6381a7320ac324bff3abb-6000x4000.jpg%3Ffit%3Dcrop%26auto%3Dformat&w=1200&q=75 1200w, /_next/image?url=https%3A%2F%2Fcdn.sanity.io%2Fimages%2F0vv8moc6%2Fchroma%2F3145743408cce26e88e6381a7320ac324bff3abb-6000x4000.jpg%3Ffit%3Dcrop%26auto%3Dformat&w=1920&q=75 1920w, /_next/image?url=https%3A%2F%2Fcdn.sanity.io%2Fimages%2F0vv8moc6%2Fchroma%2F3145743408cce26e88e6381a7320ac324bff3abb-6000x4000.jpg%3Ffit%3Dcrop%26auto%3Dformat&w=2048&q=75 2048w, /_next/image?url=https%3A%2F%2Fcdn.sanity.io%2Fimages%2F0vv8moc6%2Fchroma%2F3145743408cce26e88e6381a7320ac324bff3abb-6000x4000.jpg%3Ffit%3Dcrop%26auto%3Dformat&w=3840&q=75 3840w" src="/_next/image?url=https%3A%2F%2Fcdn.sanity.io%2Fimages%2F0vv8moc6%2Fchroma%2F3145743408cce26e88e6381a7320ac324bff3abb-6000x4000.jpg%3Ffit%3Dcrop%26auto%3Dformat&w=3840&q=75" decoding="async" data-nimg="responsive" style="border-top-left-radius:0rem;border-top-right-radius:0rem;border-bottom-left-radius:0rem;border-bottom-right-radius:0rem;position:absolute;top:0;left:0;bottom:0;right:0;box-sizing:border-box;padding:0;border:none;margin:auto;display:block;width:0;height:0;min-width:100%;max-width:100%;min-height:100%;max-height:100%" class="shrink-0" loading="lazy"/></noscript></span></div></a><div class="flex-auto w-[200%] md:w-auto ml-2 flex-1"><p class="font-bold text-[1rem] pl-4 text-undefined" style="font-size:1rem"><a href="/view/rapid-quantitative-analysis-of-ethylene-oxide-and-1-4-dioxane-in-polymeric-excipients-using-sift-mass-spectrometry?utm_source=www.chromatographyonline.com&utm_medium=relatedContent">Rapid Quantitative Analysis of Ethylene Oxide and 1,4-Dioxane in Polymeric Excipients Using SIFT-Mass Spectrometry</a></p><div class=" pl-4"><a class="text-sm text-sky-800" href="/authors/juby-mathew">Juby Mathew</a><span class="mr-1 ml-[1px]">;</span><a class="text-sm text-sky-800" href="/authors/leslie-p-silva">Leslie P. Silva</a><span class="mr-1 ml-[1px]">;</span><a class="text-sm text-sky-800" href="/authors/chad-bastian">Chad Bastian</a><span class="mr-1 ml-[1px]">;</span><a class="text-sm text-sky-800" href="/authors/christopher-williams">Christopher Williams</a><span class="mr-1 ml-[1px]">;</span><a class="text-sm text-sky-800" href="/authors/alyssa-mcburney">Alyssa McBurney</a><span class="mr-1 ml-[1px]">;</span><a class="text-sm text-sky-800" href="/authors/mark-j-perkins">Mark J. Perkins</a><span class="mr-1 ml-[1px]">;</span><a class="text-sm text-sky-800" href="/authors/vaughan-s-langford">Vaughan S. Langford</a></div><a href="/view/rapid-quantitative-analysis-of-ethylene-oxide-and-1-4-dioxane-in-polymeric-excipients-using-sift-mass-spectrometry?utm_source=www.chromatographyonline.com&utm_medium=relatedContent"><span class="text-sm text-gray-500 pl-4">November 11th 2024</span><div><span class="px-2 py-1 ml-4 text-xs text-white border bg-primary italic">Article</span></div><div class="mt-2 ml-4"></div><div class="flex flex-row gap-2"></div><p class=" mt-4 text-gray-800 pl-4">Pharmaceutical excipients, such as polyethylene glycol-based polymers, must be tested for the presence of ethylene oxide (EtO) and 1,4-dioxane as part of a safety assessment, according to USP Chapter <228>.</p><div class="pl-4"></div></a><div class="flex flex-col sm:flex-row pl-2 mt-4"></div></div></div></div></div></div><div class="mb-4 w-full h-full"><hr class="mt-1 w-full " style="border-top-width:1px;border-top-color:#F3F4F6"/><div class="w-full h-full" style="box-shadow:0px 0px 0 0 rgb(194, 194, 194, 1)"><div class="w-full md:w-auto md:flex md:flex-col md:items-center lg:items-start lg:flex-row mb-4 mt-3 p-4"><div class="flex flex-1 md:col-span-2 " style="background-color:transparent;border-color:#F3F4F6;border-width:0;border-top-left-radius:0rem;border-top-right-radius:0rem;border-bottom-left-radius:0rem;border-bottom-right-radius:0rem"><a class=" md:flex-none w-full md:w-48 mt-2" href="/view/lc-ms-ms-for-quantifying-nitrosamines-in-olmesartan-tablets?utm_source=www.chromatographyonline.com&utm_medium=relatedContent"><div class=""><span style="box-sizing:border-box;display:block;overflow:hidden;width:initial;height:initial;background:none;opacity:1;border:0;margin:0;padding:0;position:relative"><span style="box-sizing:border-box;display:block;width:initial;height:initial;background:none;opacity:1;border:0;margin:0;padding:0;padding-top:66.66%"></span><img alt="Digital blood pressure monitor and medical pills on the white table. 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style="border-top-left-radius:0rem;border-top-right-radius:0rem;border-bottom-left-radius:0rem;border-bottom-right-radius:0rem;position:absolute;top:0;left:0;bottom:0;right:0;box-sizing:border-box;padding:0;border:none;margin:auto;display:block;width:0;height:0;min-width:100%;max-width:100%;min-height:100%;max-height:100%" class="shrink-0" loading="lazy"/></noscript></span></div></a><div class="flex-auto w-[200%] md:w-auto ml-2 flex-1"><p class="font-bold text-[1rem] pl-4 text-undefined" style="font-size:1rem"><a href="/view/lc-ms-ms-for-quantifying-nitrosamines-in-olmesartan-tablets?utm_source=www.chromatographyonline.com&utm_medium=relatedContent">LC–MS/MS for Quantifying Nitrosamines in Olmesartan Tablets</a></p><div class=" pl-4"><a class="text-sm text-sky-800" href="/authors/aaron-acevedo">Aaron Acevedo</a></div><a href="/view/lc-ms-ms-for-quantifying-nitrosamines-in-olmesartan-tablets?utm_source=www.chromatographyonline.com&utm_medium=relatedContent"><span class="text-sm text-gray-500 pl-4">November 7th 2024</span><div><span class="px-2 py-1 ml-4 text-xs text-white border bg-primary italic">Article</span></div><div class="mt-2 ml-4"></div><div class="flex flex-row gap-2"></div><p class=" mt-4 text-gray-800 pl-4">Mithibai College of Arts scientists recently used liquid chromatography-tandem mass spectrometry (LC–MS/MS) for detecting nitrosamines in blood pressure medication.</p><div class="pl-4"></div></a><div class="flex flex-col sm:flex-row pl-2 mt-4"></div></div></div></div></div></div><div class="mb-4 w-full h-full"><hr class="mt-1 w-full " style="border-top-width:1px;border-top-color:#F3F4F6"/><div class="w-full h-full" style="box-shadow:0px 0px 0 0 rgb(194, 194, 194, 1)"><div class="w-full md:w-auto md:flex md:flex-col md:items-center lg:items-start lg:flex-row mb-4 mt-3 p-4"><div class="flex flex-1 md:col-span-2 " style="background-color:transparent;border-color:#F3F4F6;border-width:0;border-top-left-radius:0rem;border-top-right-radius:0rem;border-bottom-left-radius:0rem;border-bottom-right-radius:0rem"><a class=" md:flex-none w-full md:w-48 mt-2" href="/view/gc-lc-q-tof-ms-method-for-determining-pesticides-in-traditional-chinese-medicine?utm_source=www.chromatographyonline.com&utm_medium=relatedContent"><div class=""><span style="box-sizing:border-box;display:block;overflow:hidden;width:initial;height:initial;background:none;opacity:1;border:0;margin:0;padding:0;position:relative"><span style="box-sizing:border-box;display:block;width:initial;height:initial;background:none;opacity:1;border:0;margin:0;padding:0;padding-top:66.66666666666666%"></span><img alt="Vaporiser des plantes dans un jardin, jardinage entretien et protection contres les pucerons et les maladies | Image Credit: © Delphotostock - stock.adobe.com" title="Vaporiser des plantes dans un jardin, jardinage entretien et protection contres les pucerons et les maladies | Image Credit: © Delphotostock - stock.adobe.com" src="data:image/gif;base64,R0lGODlhAQABAIAAAAAAAP///yH5BAEAAAAALAAAAAABAAEAAAIBRAA7" decoding="async" data-nimg="responsive" class="shrink-0" style="border-top-left-radius:0rem;border-top-right-radius:0rem;border-bottom-left-radius:0rem;border-bottom-right-radius:0rem;position:absolute;top:0;left:0;bottom:0;right:0;box-sizing:border-box;padding:0;border:none;margin:auto;display:block;width:0;height:0;min-width:100%;max-width:100%;min-height:100%;max-height:100%"/><noscript><img alt="Vaporiser des plantes dans un jardin, jardinage entretien et protection contres les pucerons et les maladies | Image Credit: © Delphotostock - stock.adobe.com" title="Vaporiser des plantes dans un jardin, jardinage entretien et protection contres les pucerons et les maladies | Image Credit: © Delphotostock - stock.adobe.com" sizes="100vw" srcSet="/_next/image?url=https%3A%2F%2Fcdn.sanity.io%2Fimages%2F0vv8moc6%2Fchroma%2Fee0995fcd02a37971efec9205192900b9642070c-6000x4000.jpg%3Ffit%3Dcrop%26auto%3Dformat&w=640&q=75 640w, /_next/image?url=https%3A%2F%2Fcdn.sanity.io%2Fimages%2F0vv8moc6%2Fchroma%2Fee0995fcd02a37971efec9205192900b9642070c-6000x4000.jpg%3Ffit%3Dcrop%26auto%3Dformat&w=750&q=75 750w, /_next/image?url=https%3A%2F%2Fcdn.sanity.io%2Fimages%2F0vv8moc6%2Fchroma%2Fee0995fcd02a37971efec9205192900b9642070c-6000x4000.jpg%3Ffit%3Dcrop%26auto%3Dformat&w=828&q=75 828w, /_next/image?url=https%3A%2F%2Fcdn.sanity.io%2Fimages%2F0vv8moc6%2Fchroma%2Fee0995fcd02a37971efec9205192900b9642070c-6000x4000.jpg%3Ffit%3Dcrop%26auto%3Dformat&w=1080&q=75 1080w, /_next/image?url=https%3A%2F%2Fcdn.sanity.io%2Fimages%2F0vv8moc6%2Fchroma%2Fee0995fcd02a37971efec9205192900b9642070c-6000x4000.jpg%3Ffit%3Dcrop%26auto%3Dformat&w=1200&q=75 1200w, 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style="border-top-left-radius:0rem;border-top-right-radius:0rem;border-bottom-left-radius:0rem;border-bottom-right-radius:0rem;position:absolute;top:0;left:0;bottom:0;right:0;box-sizing:border-box;padding:0;border:none;margin:auto;display:block;width:0;height:0;min-width:100%;max-width:100%;min-height:100%;max-height:100%" class="shrink-0" loading="lazy"/></noscript></span></div></a><div class="flex-auto w-[200%] md:w-auto ml-2 flex-1"><p class="font-bold text-[1rem] pl-4 text-undefined" style="font-size:1rem"><a href="/view/gc-lc-q-tof-ms-method-for-determining-pesticides-in-traditional-chinese-medicine?utm_source=www.chromatographyonline.com&utm_medium=relatedContent">GC/LC-Q-TOF/MS Method for Determining Pesticides in Traditional Chinese Medicine</a></p><div class=" pl-4"><a class="text-sm text-sky-800" href="/authors/aaron-acevedo">Aaron Acevedo</a></div><a href="/view/gc-lc-q-tof-ms-method-for-determining-pesticides-in-traditional-chinese-medicine?utm_source=www.chromatographyonline.com&utm_medium=relatedContent"><span class="text-sm text-gray-500 pl-4">November 4th 2024</span><div><span class="px-2 py-1 ml-4 text-xs text-white border bg-primary italic">Article</span></div><div class="mt-2 ml-4"></div><div class="flex flex-row gap-2"></div><p class=" mt-4 text-gray-800 pl-4">Scientists recently developed new GC/LC-Q-TOF/MS-based method for determining pesticides in Angelica sinensis, a traditional Chinese medicine.</p><div class="pl-4"></div></a><div class="flex flex-col sm:flex-row pl-2 mt-4"></div></div></div></div></div></div><div class="mb-4 w-full h-full"><hr class="mt-1 w-full " style="border-top-width:1px;border-top-color:#F3F4F6"/><div class="w-full h-full" style="box-shadow:0px 0px 0 0 rgb(194, 194, 194, 1)"><div class="w-full md:w-auto md:flex md:flex-col md:items-center lg:items-start lg:flex-row mb-4 mt-3 p-4"><div 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Experimental laboratory | Image Credit: © my kids - stock.adobe.com" title="Scientist working with multichannel pipette. Experimental laboratory | Image Credit: © my kids - stock.adobe.com" src="data:image/gif;base64,R0lGODlhAQABAIAAAAAAAP///yH5BAEAAAAALAAAAAABAAEAAAIBRAA7" decoding="async" data-nimg="responsive" class="shrink-0" style="border-top-left-radius:0rem;border-top-right-radius:0rem;border-bottom-left-radius:0rem;border-bottom-right-radius:0rem;position:absolute;top:0;left:0;bottom:0;right:0;box-sizing:border-box;padding:0;border:none;margin:auto;display:block;width:0;height:0;min-width:100%;max-width:100%;min-height:100%;max-height:100%"/><noscript><img alt="Scientist working with multichannel pipette. Experimental laboratory | Image Credit: © my kids - stock.adobe.com" title="Scientist working with multichannel pipette. Experimental laboratory | Image Credit: © my kids - stock.adobe.com" sizes="100vw" srcSet="/_next/image?url=https%3A%2F%2Fcdn.sanity.io%2Fimages%2F0vv8moc6%2Fchroma%2F99c6fbbe2824a68b5900b244dc83d6133af65420-1080x1920.jpg%3Ffit%3Dcrop%26auto%3Dformat&w=640&q=75 640w, /_next/image?url=https%3A%2F%2Fcdn.sanity.io%2Fimages%2F0vv8moc6%2Fchroma%2F99c6fbbe2824a68b5900b244dc83d6133af65420-1080x1920.jpg%3Ffit%3Dcrop%26auto%3Dformat&w=750&q=75 750w, /_next/image?url=https%3A%2F%2Fcdn.sanity.io%2Fimages%2F0vv8moc6%2Fchroma%2F99c6fbbe2824a68b5900b244dc83d6133af65420-1080x1920.jpg%3Ffit%3Dcrop%26auto%3Dformat&w=828&q=75 828w, /_next/image?url=https%3A%2F%2Fcdn.sanity.io%2Fimages%2F0vv8moc6%2Fchroma%2F99c6fbbe2824a68b5900b244dc83d6133af65420-1080x1920.jpg%3Ffit%3Dcrop%26auto%3Dformat&w=1080&q=75 1080w, /_next/image?url=https%3A%2F%2Fcdn.sanity.io%2Fimages%2F0vv8moc6%2Fchroma%2F99c6fbbe2824a68b5900b244dc83d6133af65420-1080x1920.jpg%3Ffit%3Dcrop%26auto%3Dformat&w=1200&q=75 1200w, 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style="border-top-left-radius:0rem;border-top-right-radius:0rem;border-bottom-left-radius:0rem;border-bottom-right-radius:0rem;position:absolute;top:0;left:0;bottom:0;right:0;box-sizing:border-box;padding:0;border:none;margin:auto;display:block;width:0;height:0;min-width:100%;max-width:100%;min-height:100%;max-height:100%" class="shrink-0" loading="lazy"/></noscript></span></div></a><div class="flex-auto w-[200%] md:w-auto ml-2 flex-1"><p class="font-bold text-[1rem] pl-4 text-undefined" style="font-size:1rem"><a href="/view/mentorship-in-science-insights-from-fems-empowerment-award-winner-faith-johnson?utm_source=www.chromatographyonline.com&utm_medium=relatedContent">Mentorship in Science: Insights from FeMS Empowerment Award Winner Faith Johnson</a></p><div class=" pl-4"><a class="text-sm text-sky-800" href="/authors/aaron-acevedo">Aaron Acevedo</a></div><a href="/view/mentorship-in-science-insights-from-fems-empowerment-award-winner-faith-johnson?utm_source=www.chromatographyonline.com&utm_medium=relatedContent"><span class="text-sm text-gray-500 pl-4">November 4th 2024</span><div><span class="px-2 py-1 ml-4 text-xs text-white border bg-primary italic">Article</span></div><div class="mt-2 ml-4"></div><div class="flex flex-row gap-2"></div><p class=" mt-4 text-gray-800 pl-4">LCGC International sat down with Faith Johnson of ECOLAB to discuss her career and work with the Females in Mass Spectrometry (FeMS) group.</p><div class="pl-4"></div></a><div class="flex flex-col sm:flex-row pl-2 mt-4"></div></div></div></div></div></div></div></div></div><div class="relative hidden sm:block"><div class="mt-4 overflow-hidden"><div class="flex items-center clear-both pt-4 text-xl font-bold">Related Content </div><div class="w-full mb-2 border border-secondary"></div><div class="flex flex-wrap items-center"></div><div class="flex flex-wrap w-full"><div 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href="/view/best-of-the-week-eas-2024-awardees-oligonucleotides-in-drug-development-and-more?utm_source=www.chromatographyonline.com&utm_medium=relatedContent"><span class="text-sm text-gray-500 pl-4">November 22nd 2024</span><div><span class="px-2 py-1 ml-4 text-xs text-white border bg-primary italic">Article</span></div><div class="mt-2 ml-4"></div><div class="flex flex-row gap-2"></div><p class=" mt-4 text-gray-800 pl-4">Here is some of the most popular content posted on LCGC International this week.</p><div class="pl-4"></div></a><div class="flex flex-col sm:flex-row pl-2 mt-4"></div></div></div></div></div></div><div class="mb-4 w-full h-full"><hr class="mt-1 w-full " style="border-top-width:1px;border-top-color:#F3F4F6"/><div class="w-full h-full" style="box-shadow:0px 0px 0 0 rgb(194, 194, 194, 1)"><div class="w-full md:w-auto md:flex md:flex-col md:items-center lg:items-start lg:flex-row mb-4 mt-3 p-4"><div class="flex flex-1 md:col-span-2 " style="background-color:transparent;border-color:#F3F4F6;border-width:0;border-top-left-radius:0rem;border-top-right-radius:0rem;border-bottom-left-radius:0rem;border-bottom-right-radius:0rem"><a class=" md:flex-none w-full md:w-48 mt-2" href="/view/in-bruges-hplc-2025?utm_source=www.chromatographyonline.com&utm_medium=relatedContent"><div class=""><span style="box-sizing:border-box;display:block;overflow:hidden;width:initial;height:initial;background:none;opacity:1;border:0;margin:0;padding:0;position:relative"><span style="box-sizing:border-box;display:block;width:initial;height:initial;background:none;opacity:1;border:0;margin:0;padding:0;padding-top:66.66666666666666%"></span><img alt="Canals of Bruges, Belgium | Image Credit: © gqxue - stock.adobe.com" title="Canals of Bruges, Belgium | Image Credit: © gqxue - stock.adobe.com" src="data:image/gif;base64,R0lGODlhAQABAIAAAAAAAP///yH5BAEAAAAALAAAAAABAAEAAAIBRAA7" decoding="async" data-nimg="responsive" class="shrink-0" style="border-top-left-radius:0rem;border-top-right-radius:0rem;border-bottom-left-radius:0rem;border-bottom-right-radius:0rem;position:absolute;top:0;left:0;bottom:0;right:0;box-sizing:border-box;padding:0;border:none;margin:auto;display:block;width:0;height:0;min-width:100%;max-width:100%;min-height:100%;max-height:100%"/><noscript><img alt="Canals of Bruges, Belgium | Image Credit: © gqxue - stock.adobe.com" title="Canals of Bruges, Belgium | Image Credit: © gqxue - stock.adobe.com" sizes="100vw" srcSet="/_next/image?url=https%3A%2F%2Fcdn.sanity.io%2Fimages%2F0vv8moc6%2Fchroma%2F0aa31539c817c805fe12018157a1e8171b6150fa-3600x2400.jpg%3Ffit%3Dcrop%26auto%3Dformat&w=640&q=75 640w, /_next/image?url=https%3A%2F%2Fcdn.sanity.io%2Fimages%2F0vv8moc6%2Fchroma%2F0aa31539c817c805fe12018157a1e8171b6150fa-3600x2400.jpg%3Ffit%3Dcrop%26auto%3Dformat&w=750&q=75 750w, 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href="/view/in-bruges-hplc-2025?utm_source=www.chromatographyonline.com&utm_medium=relatedContent">In Bruges: HPLC 2025</a></p><div class=" pl-4"><a class="text-sm text-sky-800" href="/authors/gert-desmet">Gert Desmet</a><span class="mr-1 ml-[1px]">;</span><a class="text-sm text-sky-800" href="/authors/deirdre-cabooter">Deirdre Cabooter</a><span class="mr-1 ml-[1px]">;</span><a class="text-sm text-sky-800" href="/authors/frederic-lynen">Frédéric Lynen</a><span class="mr-1 ml-[1px]">;</span><a class="text-sm text-sky-800" href="/authors/sebastiaan-eeltink">Sebastiaan Eeltink</a><span class="mr-1 ml-[1px]">;</span><a class="text-sm text-sky-800" href="/authors/ken-broeckhoven">Ken Broeckhoven</a></div><a href="/view/in-bruges-hplc-2025?utm_source=www.chromatographyonline.com&utm_medium=relatedContent"><span class="text-sm text-gray-500 pl-4">November 13th 2024</span><div><span class="px-2 py-1 ml-4 text-xs text-white border bg-primary italic">Article</span></div><div class="mt-2 ml-4"></div><div class="flex flex-row gap-2"></div><p class=" mt-4 text-gray-800 pl-4">The 54th International Symposium on High Performance Liquid Phase Separations and Related Techniques (HPLC 2025) will be held from Sunday through Thursday, June 15-19, 2025, in Bruges, Belgium.</p><div class="pl-4"></div></a><div class="flex flex-col sm:flex-row pl-2 mt-4"></div></div></div></div></div></div><div class="mb-4 w-full h-full"><hr class="mt-1 w-full " style="border-top-width:1px;border-top-color:#F3F4F6"/><div class="flex md:hidden justify-center items-center"></div><div class="w-full h-full" style="box-shadow:0px 0px 0 0 rgb(194, 194, 194, 1)"><div class="w-full md:w-auto md:flex md:flex-col md:items-center lg:items-start lg:flex-row mb-4 mt-3 p-4"><div class="flex flex-1 md:col-span-2 " style="background-color:transparent;border-color:#F3F4F6;border-width:0;border-top-left-radius:0rem;border-top-right-radius:0rem;border-bottom-left-radius:0rem;border-bottom-right-radius:0rem"><a class=" md:flex-none w-full md:w-48 mt-2" href="/view/rapid-quantitative-analysis-of-ethylene-oxide-and-1-4-dioxane-in-polymeric-excipients-using-sift-mass-spectrometry?utm_source=www.chromatographyonline.com&utm_medium=relatedContent"><div class=""><span style="box-sizing:border-box;display:block;overflow:hidden;width:initial;height:initial;background:none;opacity:1;border:0;margin:0;padding:0;position:relative"><span style="box-sizing:border-box;display:block;width:initial;height:initial;background:none;opacity:1;border:0;margin:0;padding:0;padding-top:66.66666666666666%"></span><img alt="Molecule of ethylene oxide, ball-and-stick molecular model. Scientific 3d rendering | Image Credit: © Alexey Novikov - stock.adobe.com" title="Molecule of ethylene oxide, ball-and-stick molecular model. Scientific 3d rendering | Image Credit: © Alexey Novikov - stock.adobe.com" src="data:image/gif;base64,R0lGODlhAQABAIAAAAAAAP///yH5BAEAAAAALAAAAAABAAEAAAIBRAA7" decoding="async" data-nimg="responsive" class="shrink-0" style="border-top-left-radius:0rem;border-top-right-radius:0rem;border-bottom-left-radius:0rem;border-bottom-right-radius:0rem;position:absolute;top:0;left:0;bottom:0;right:0;box-sizing:border-box;padding:0;border:none;margin:auto;display:block;width:0;height:0;min-width:100%;max-width:100%;min-height:100%;max-height:100%"/><noscript><img alt="Molecule of ethylene oxide, ball-and-stick molecular model. Scientific 3d rendering | Image Credit: © Alexey Novikov - stock.adobe.com" title="Molecule of ethylene oxide, ball-and-stick molecular model. Scientific 3d rendering | Image Credit: © Alexey Novikov - stock.adobe.com" sizes="100vw" srcSet="/_next/image?url=https%3A%2F%2Fcdn.sanity.io%2Fimages%2F0vv8moc6%2Fchroma%2F3145743408cce26e88e6381a7320ac324bff3abb-6000x4000.jpg%3Ffit%3Dcrop%26auto%3Dformat&w=640&q=75 640w, /_next/image?url=https%3A%2F%2Fcdn.sanity.io%2Fimages%2F0vv8moc6%2Fchroma%2F3145743408cce26e88e6381a7320ac324bff3abb-6000x4000.jpg%3Ffit%3Dcrop%26auto%3Dformat&w=750&q=75 750w, /_next/image?url=https%3A%2F%2Fcdn.sanity.io%2Fimages%2F0vv8moc6%2Fchroma%2F3145743408cce26e88e6381a7320ac324bff3abb-6000x4000.jpg%3Ffit%3Dcrop%26auto%3Dformat&w=828&q=75 828w, /_next/image?url=https%3A%2F%2Fcdn.sanity.io%2Fimages%2F0vv8moc6%2Fchroma%2F3145743408cce26e88e6381a7320ac324bff3abb-6000x4000.jpg%3Ffit%3Dcrop%26auto%3Dformat&w=1080&q=75 1080w, /_next/image?url=https%3A%2F%2Fcdn.sanity.io%2Fimages%2F0vv8moc6%2Fchroma%2F3145743408cce26e88e6381a7320ac324bff3abb-6000x4000.jpg%3Ffit%3Dcrop%26auto%3Dformat&w=1200&q=75 1200w, /_next/image?url=https%3A%2F%2Fcdn.sanity.io%2Fimages%2F0vv8moc6%2Fchroma%2F3145743408cce26e88e6381a7320ac324bff3abb-6000x4000.jpg%3Ffit%3Dcrop%26auto%3Dformat&w=1920&q=75 1920w, /_next/image?url=https%3A%2F%2Fcdn.sanity.io%2Fimages%2F0vv8moc6%2Fchroma%2F3145743408cce26e88e6381a7320ac324bff3abb-6000x4000.jpg%3Ffit%3Dcrop%26auto%3Dformat&w=2048&q=75 2048w, /_next/image?url=https%3A%2F%2Fcdn.sanity.io%2Fimages%2F0vv8moc6%2Fchroma%2F3145743408cce26e88e6381a7320ac324bff3abb-6000x4000.jpg%3Ffit%3Dcrop%26auto%3Dformat&w=3840&q=75 3840w" src="/_next/image?url=https%3A%2F%2Fcdn.sanity.io%2Fimages%2F0vv8moc6%2Fchroma%2F3145743408cce26e88e6381a7320ac324bff3abb-6000x4000.jpg%3Ffit%3Dcrop%26auto%3Dformat&w=3840&q=75" decoding="async" data-nimg="responsive" style="border-top-left-radius:0rem;border-top-right-radius:0rem;border-bottom-left-radius:0rem;border-bottom-right-radius:0rem;position:absolute;top:0;left:0;bottom:0;right:0;box-sizing:border-box;padding:0;border:none;margin:auto;display:block;width:0;height:0;min-width:100%;max-width:100%;min-height:100%;max-height:100%" class="shrink-0" loading="lazy"/></noscript></span></div></a><div class="flex-auto w-[200%] md:w-auto ml-2 flex-1"><p class="font-bold text-[1rem] pl-4 text-undefined" style="font-size:1rem"><a href="/view/rapid-quantitative-analysis-of-ethylene-oxide-and-1-4-dioxane-in-polymeric-excipients-using-sift-mass-spectrometry?utm_source=www.chromatographyonline.com&utm_medium=relatedContent">Rapid Quantitative Analysis of Ethylene Oxide and 1,4-Dioxane in Polymeric Excipients Using SIFT-Mass Spectrometry</a></p><div class=" pl-4"><a class="text-sm text-sky-800" href="/authors/juby-mathew">Juby Mathew</a><span class="mr-1 ml-[1px]">;</span><a class="text-sm text-sky-800" href="/authors/leslie-p-silva">Leslie P. Silva</a><span class="mr-1 ml-[1px]">;</span><a class="text-sm text-sky-800" href="/authors/chad-bastian">Chad Bastian</a><span class="mr-1 ml-[1px]">;</span><a class="text-sm text-sky-800" href="/authors/christopher-williams">Christopher Williams</a><span class="mr-1 ml-[1px]">;</span><a class="text-sm text-sky-800" href="/authors/alyssa-mcburney">Alyssa McBurney</a><span class="mr-1 ml-[1px]">;</span><a class="text-sm text-sky-800" href="/authors/mark-j-perkins">Mark J. Perkins</a><span class="mr-1 ml-[1px]">;</span><a class="text-sm text-sky-800" href="/authors/vaughan-s-langford">Vaughan S. Langford</a></div><a href="/view/rapid-quantitative-analysis-of-ethylene-oxide-and-1-4-dioxane-in-polymeric-excipients-using-sift-mass-spectrometry?utm_source=www.chromatographyonline.com&utm_medium=relatedContent"><span class="text-sm text-gray-500 pl-4">November 11th 2024</span><div><span class="px-2 py-1 ml-4 text-xs text-white border bg-primary italic">Article</span></div><div class="mt-2 ml-4"></div><div class="flex flex-row gap-2"></div><p class=" mt-4 text-gray-800 pl-4">Pharmaceutical excipients, such as polyethylene glycol-based polymers, must be tested for the presence of ethylene oxide (EtO) and 1,4-dioxane as part of a safety assessment, according to USP Chapter <228>.</p><div class="pl-4"></div></a><div class="flex flex-col sm:flex-row pl-2 mt-4"></div></div></div></div></div></div><div class="mb-4 w-full h-full"><hr class="mt-1 w-full " style="border-top-width:1px;border-top-color:#F3F4F6"/><div class="w-full h-full" style="box-shadow:0px 0px 0 0 rgb(194, 194, 194, 1)"><div class="w-full md:w-auto md:flex md:flex-col md:items-center lg:items-start lg:flex-row mb-4 mt-3 p-4"><div class="flex flex-1 md:col-span-2 " style="background-color:transparent;border-color:#F3F4F6;border-width:0;border-top-left-radius:0rem;border-top-right-radius:0rem;border-bottom-left-radius:0rem;border-bottom-right-radius:0rem"><a class=" md:flex-none w-full md:w-48 mt-2" href="/view/lc-ms-ms-for-quantifying-nitrosamines-in-olmesartan-tablets?utm_source=www.chromatographyonline.com&utm_medium=relatedContent"><div class=""><span style="box-sizing:border-box;display:block;overflow:hidden;width:initial;height:initial;background:none;opacity:1;border:0;margin:0;padding:0;position:relative"><span style="box-sizing:border-box;display:block;width:initial;height:initial;background:none;opacity:1;border:0;margin:0;padding:0;padding-top:66.66%"></span><img alt="Digital blood pressure monitor and medical pills on the white table. 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/_next/image?url=https%3A%2F%2Fcdn.sanity.io%2Fimages%2F0vv8moc6%2Fchroma%2F58352ec1f223f0f661d6a54f78b174cb3d0d81a5-5000x3333.jpg%3Ffit%3Dcrop%26auto%3Dformat&w=1920&q=75 1920w, /_next/image?url=https%3A%2F%2Fcdn.sanity.io%2Fimages%2F0vv8moc6%2Fchroma%2F58352ec1f223f0f661d6a54f78b174cb3d0d81a5-5000x3333.jpg%3Ffit%3Dcrop%26auto%3Dformat&w=2048&q=75 2048w, /_next/image?url=https%3A%2F%2Fcdn.sanity.io%2Fimages%2F0vv8moc6%2Fchroma%2F58352ec1f223f0f661d6a54f78b174cb3d0d81a5-5000x3333.jpg%3Ffit%3Dcrop%26auto%3Dformat&w=3840&q=75 3840w" src="/_next/image?url=https%3A%2F%2Fcdn.sanity.io%2Fimages%2F0vv8moc6%2Fchroma%2F58352ec1f223f0f661d6a54f78b174cb3d0d81a5-5000x3333.jpg%3Ffit%3Dcrop%26auto%3Dformat&w=3840&q=75" decoding="async" data-nimg="responsive" style="border-top-left-radius:0rem;border-top-right-radius:0rem;border-bottom-left-radius:0rem;border-bottom-right-radius:0rem;position:absolute;top:0;left:0;bottom:0;right:0;box-sizing:border-box;padding:0;border:none;margin:auto;display:block;width:0;height:0;min-width:100%;max-width:100%;min-height:100%;max-height:100%" class="shrink-0" loading="lazy"/></noscript></span></div></a><div class="flex-auto w-[200%] md:w-auto ml-2 flex-1"><p class="font-bold text-[1rem] pl-4 text-undefined" style="font-size:1rem"><a href="/view/lc-ms-ms-for-quantifying-nitrosamines-in-olmesartan-tablets?utm_source=www.chromatographyonline.com&utm_medium=relatedContent">LC–MS/MS for Quantifying Nitrosamines in Olmesartan Tablets</a></p><div class=" pl-4"><a class="text-sm text-sky-800" href="/authors/aaron-acevedo">Aaron Acevedo</a></div><a href="/view/lc-ms-ms-for-quantifying-nitrosamines-in-olmesartan-tablets?utm_source=www.chromatographyonline.com&utm_medium=relatedContent"><span class="text-sm text-gray-500 pl-4">November 7th 2024</span><div><span class="px-2 py-1 ml-4 text-xs text-white border bg-primary italic">Article</span></div><div class="mt-2 ml-4"></div><div class="flex flex-row gap-2"></div><p class=" mt-4 text-gray-800 pl-4">Mithibai College of Arts scientists recently used liquid chromatography-tandem mass spectrometry (LC–MS/MS) for detecting nitrosamines in blood pressure medication.</p><div class="pl-4"></div></a><div class="flex flex-col sm:flex-row pl-2 mt-4"></div></div></div></div></div></div><div class="mb-4 w-full h-full"><hr class="mt-1 w-full " style="border-top-width:1px;border-top-color:#F3F4F6"/><div class="w-full h-full" style="box-shadow:0px 0px 0 0 rgb(194, 194, 194, 1)"><div class="w-full md:w-auto md:flex md:flex-col md:items-center lg:items-start lg:flex-row mb-4 mt-3 p-4"><div class="flex flex-1 md:col-span-2 " style="background-color:transparent;border-color:#F3F4F6;border-width:0;border-top-left-radius:0rem;border-top-right-radius:0rem;border-bottom-left-radius:0rem;border-bottom-right-radius:0rem"><a class=" md:flex-none w-full md:w-48 mt-2" href="/view/gc-lc-q-tof-ms-method-for-determining-pesticides-in-traditional-chinese-medicine?utm_source=www.chromatographyonline.com&utm_medium=relatedContent"><div class=""><span style="box-sizing:border-box;display:block;overflow:hidden;width:initial;height:initial;background:none;opacity:1;border:0;margin:0;padding:0;position:relative"><span style="box-sizing:border-box;display:block;width:initial;height:initial;background:none;opacity:1;border:0;margin:0;padding:0;padding-top:66.66666666666666%"></span><img alt="Vaporiser des plantes dans un jardin, jardinage entretien et protection contres les pucerons et les maladies | Image Credit: © Delphotostock - stock.adobe.com" title="Vaporiser des plantes dans un jardin, jardinage entretien et protection contres les pucerons et les maladies | Image Credit: © Delphotostock - stock.adobe.com" src="data:image/gif;base64,R0lGODlhAQABAIAAAAAAAP///yH5BAEAAAAALAAAAAABAAEAAAIBRAA7" decoding="async" data-nimg="responsive" class="shrink-0" style="border-top-left-radius:0rem;border-top-right-radius:0rem;border-bottom-left-radius:0rem;border-bottom-right-radius:0rem;position:absolute;top:0;left:0;bottom:0;right:0;box-sizing:border-box;padding:0;border:none;margin:auto;display:block;width:0;height:0;min-width:100%;max-width:100%;min-height:100%;max-height:100%"/><noscript><img alt="Vaporiser des plantes dans un jardin, jardinage entretien et protection contres les pucerons et les maladies | Image Credit: © Delphotostock - stock.adobe.com" title="Vaporiser des plantes dans un jardin, jardinage entretien et protection contres les pucerons et les maladies | Image Credit: © Delphotostock - stock.adobe.com" sizes="100vw" 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style="border-top-left-radius:0rem;border-top-right-radius:0rem;border-bottom-left-radius:0rem;border-bottom-right-radius:0rem;position:absolute;top:0;left:0;bottom:0;right:0;box-sizing:border-box;padding:0;border:none;margin:auto;display:block;width:0;height:0;min-width:100%;max-width:100%;min-height:100%;max-height:100%" class="shrink-0" loading="lazy"/></noscript></span></div></a><div class="flex-auto w-[200%] md:w-auto ml-2 flex-1"><p class="font-bold text-[1rem] pl-4 text-undefined" style="font-size:1rem"><a href="/view/gc-lc-q-tof-ms-method-for-determining-pesticides-in-traditional-chinese-medicine?utm_source=www.chromatographyonline.com&utm_medium=relatedContent">GC/LC-Q-TOF/MS Method for Determining Pesticides in Traditional Chinese Medicine</a></p><div class=" pl-4"><a class="text-sm text-sky-800" href="/authors/aaron-acevedo">Aaron Acevedo</a></div><a href="/view/gc-lc-q-tof-ms-method-for-determining-pesticides-in-traditional-chinese-medicine?utm_source=www.chromatographyonline.com&utm_medium=relatedContent"><span class="text-sm text-gray-500 pl-4">November 4th 2024</span><div><span class="px-2 py-1 ml-4 text-xs text-white border bg-primary italic">Article</span></div><div class="mt-2 ml-4"></div><div class="flex flex-row gap-2"></div><p class=" mt-4 text-gray-800 pl-4">Scientists recently developed new GC/LC-Q-TOF/MS-based method for determining pesticides in Angelica sinensis, a traditional Chinese medicine.</p><div class="pl-4"></div></a><div class="flex flex-col sm:flex-row pl-2 mt-4"></div></div></div></div></div></div><div class="mb-4 w-full h-full"><hr class="mt-1 w-full " style="border-top-width:1px;border-top-color:#F3F4F6"/><div class="w-full h-full" style="box-shadow:0px 0px 0 0 rgb(194, 194, 194, 1)"><div class="w-full md:w-auto md:flex md:flex-col md:items-center lg:items-start lg:flex-row mb-4 mt-3 p-4"><div class="flex flex-1 md:col-span-2 " style="background-color:transparent;border-color:#F3F4F6;border-width:0;border-top-left-radius:0rem;border-top-right-radius:0rem;border-bottom-left-radius:0rem;border-bottom-right-radius:0rem"><a class=" md:flex-none w-full md:w-48 mt-2" href="/view/mentorship-in-science-insights-from-fems-empowerment-award-winner-faith-johnson?utm_source=www.chromatographyonline.com&utm_medium=relatedContent"><div class=""><span style="box-sizing:border-box;display:block;overflow:hidden;width:initial;height:initial;background:none;opacity:1;border:0;margin:0;padding:0;position:relative"><span style="box-sizing:border-box;display:block;width:initial;height:initial;background:none;opacity:1;border:0;margin:0;padding:0;padding-top:177.77777777777777%"></span><img alt="Scientist working with multichannel pipette. Experimental laboratory | Image Credit: © my kids - stock.adobe.com" title="Scientist working with multichannel pipette. Experimental laboratory | Image Credit: © my kids - stock.adobe.com" src="data:image/gif;base64,R0lGODlhAQABAIAAAAAAAP///yH5BAEAAAAALAAAAAABAAEAAAIBRAA7" decoding="async" data-nimg="responsive" class="shrink-0" style="border-top-left-radius:0rem;border-top-right-radius:0rem;border-bottom-left-radius:0rem;border-bottom-right-radius:0rem;position:absolute;top:0;left:0;bottom:0;right:0;box-sizing:border-box;padding:0;border:none;margin:auto;display:block;width:0;height:0;min-width:100%;max-width:100%;min-height:100%;max-height:100%"/><noscript><img alt="Scientist working with multichannel pipette. Experimental laboratory | Image Credit: © my kids - stock.adobe.com" title="Scientist working with multichannel pipette. Experimental laboratory | Image Credit: © my kids - stock.adobe.com" sizes="100vw" srcSet="/_next/image?url=https%3A%2F%2Fcdn.sanity.io%2Fimages%2F0vv8moc6%2Fchroma%2F99c6fbbe2824a68b5900b244dc83d6133af65420-1080x1920.jpg%3Ffit%3Dcrop%26auto%3Dformat&w=640&q=75 640w, /_next/image?url=https%3A%2F%2Fcdn.sanity.io%2Fimages%2F0vv8moc6%2Fchroma%2F99c6fbbe2824a68b5900b244dc83d6133af65420-1080x1920.jpg%3Ffit%3Dcrop%26auto%3Dformat&w=750&q=75 750w, /_next/image?url=https%3A%2F%2Fcdn.sanity.io%2Fimages%2F0vv8moc6%2Fchroma%2F99c6fbbe2824a68b5900b244dc83d6133af65420-1080x1920.jpg%3Ffit%3Dcrop%26auto%3Dformat&w=828&q=75 828w, /_next/image?url=https%3A%2F%2Fcdn.sanity.io%2Fimages%2F0vv8moc6%2Fchroma%2F99c6fbbe2824a68b5900b244dc83d6133af65420-1080x1920.jpg%3Ffit%3Dcrop%26auto%3Dformat&w=1080&q=75 1080w, /_next/image?url=https%3A%2F%2Fcdn.sanity.io%2Fimages%2F0vv8moc6%2Fchroma%2F99c6fbbe2824a68b5900b244dc83d6133af65420-1080x1920.jpg%3Ffit%3Dcrop%26auto%3Dformat&w=1200&q=75 1200w, /_next/image?url=https%3A%2F%2Fcdn.sanity.io%2Fimages%2F0vv8moc6%2Fchroma%2F99c6fbbe2824a68b5900b244dc83d6133af65420-1080x1920.jpg%3Ffit%3Dcrop%26auto%3Dformat&w=1920&q=75 1920w, /_next/image?url=https%3A%2F%2Fcdn.sanity.io%2Fimages%2F0vv8moc6%2Fchroma%2F99c6fbbe2824a68b5900b244dc83d6133af65420-1080x1920.jpg%3Ffit%3Dcrop%26auto%3Dformat&w=2048&q=75 2048w, /_next/image?url=https%3A%2F%2Fcdn.sanity.io%2Fimages%2F0vv8moc6%2Fchroma%2F99c6fbbe2824a68b5900b244dc83d6133af65420-1080x1920.jpg%3Ffit%3Dcrop%26auto%3Dformat&w=3840&q=75 3840w" src="/_next/image?url=https%3A%2F%2Fcdn.sanity.io%2Fimages%2F0vv8moc6%2Fchroma%2F99c6fbbe2824a68b5900b244dc83d6133af65420-1080x1920.jpg%3Ffit%3Dcrop%26auto%3Dformat&w=3840&q=75" decoding="async" data-nimg="responsive" style="border-top-left-radius:0rem;border-top-right-radius:0rem;border-bottom-left-radius:0rem;border-bottom-right-radius:0rem;position:absolute;top:0;left:0;bottom:0;right:0;box-sizing:border-box;padding:0;border:none;margin:auto;display:block;width:0;height:0;min-width:100%;max-width:100%;min-height:100%;max-height:100%" class="shrink-0" loading="lazy"/></noscript></span></div></a><div class="flex-auto w-[200%] md:w-auto ml-2 flex-1"><p class="font-bold text-[1rem] pl-4 text-undefined" style="font-size:1rem"><a href="/view/mentorship-in-science-insights-from-fems-empowerment-award-winner-faith-johnson?utm_source=www.chromatographyonline.com&utm_medium=relatedContent">Mentorship in Science: Insights from FeMS Empowerment Award Winner Faith Johnson</a></p><div class=" pl-4"><a class="text-sm text-sky-800" href="/authors/aaron-acevedo">Aaron Acevedo</a></div><a href="/view/mentorship-in-science-insights-from-fems-empowerment-award-winner-faith-johnson?utm_source=www.chromatographyonline.com&utm_medium=relatedContent"><span class="text-sm text-gray-500 pl-4">November 4th 2024</span><div><span class="px-2 py-1 ml-4 text-xs text-white border bg-primary italic">Article</span></div><div class="mt-2 ml-4"></div><div class="flex flex-row gap-2"></div><p class=" mt-4 text-gray-800 pl-4">LCGC International sat down with Faith Johnson of ECOLAB to discuss her career and work with the Females in Mass Spectrometry (FeMS) group.</p><div class="pl-4"></div></a><div class="flex flex-col sm:flex-row pl-2 mt-4"></div></div></div></div></div></div></div></div></div><div class="pb-24"></div></div><script type="application/ld+json">{"@context":"https://schema.org","@type":"NewsArticle","headline":"Development of Stability-Indicating Analytical Procedures by HPLC: An Overview and Best Practices","datePublished":"2020-08-01T04:00:00.000Z","dateModified":"2021-08-24T17:28:31Z","inLanguage":"en-US","image":"https://cdn.sanity.io/images/0vv8moc6/chroma/78e8a3bd7de9cfb62a1bbc26d7b392653c04a3b2-11367x3736.jpg?fit=crop&auto=format","mainEntityOfPage":{"@type":"WebPage","@id":"https://www.chromatographyonline.com/view/development-of-stability-indicating-analytical-procedures-by-hplc-an-overview-and-best-practices"},"publisher":{"@type":"Organization","name":"Chromatography Online","logo":{"@type":"ImageObject","url":"https://www.chromatographyonline.com/LCGCInternational_Trademark_MainLogo_NoTagline+White.png"}},"keywords":"Perspectives,HPLC,methods","articleBody":"This installment is the second in a series of three white papers on stability studies and testing of pharmaceuticals. It focuses on the development of stability-indicating high performance liquid chromatography (HPLC) methods for drug substances and products. This paper provides an overview of the fundamentals and best practices in method development, including the traditional and other easier approaches, as well as modern trends and software tools for expediting the process. The regulatory guidance on the necessary contents of a well-written method, strategies for efficient method execution, and life cycle management of analytical procedures, are described.\n\nHigh performance liquid chromatography (HPLC) method development can be a time-consuming process, particularly for stability-indicating analytical procedures of new chemical entities (NCEs). Most of the procedures for small-molecule drugs employ gradient reversed-phase liquid chromatography (RPLC) with ultraviolet (UV) detection. These methods are designed to separate and quantitate the active pharmaceutical ingredients (APIs) and all process impurities and degradation products in drug substance (DS) and drug product (DP) samples. This important HPLC method category provides quality assessment data required in product release and stability studies in regulatory filings and procedures (Table I). Information on the HPLC method development process and requirements are available in many textbooks (1–6), journal articles (7–13), regulatory guidance documents (14–16), and other resources (17). In this installment, we strive to provide a concise but comprehensive overview of the essential steps of the method development process, supported with case studies, common practices, regulatory guidance, and citations of critical references.\n\n\n\n\n\nWhy Gradient RPLC with UV Detection for Stability-Indicating Methods?\n\nLet us start with the fundamentals and the rationale for the use of RPLC and UV methods in stability-indicating analytical procedures, which must separate the API from all impurities, and meet stringent regulatory requirements in method performance (6,14–16).\n\nFirst, the primary retention mechanism in RPLC is hydrophobic interaction, particularly useful for compounds with intermediate polarities, and an excellent match of most small-molecule drugs with oral bioavailability (2). The weak dispersive forces in RPLC ensure that all components in the sample can be eluted from the column using strong purging solvents at the end of the gradient, thus yielding 100% recovery of the injected sample.\n\nSecond, the elution order in RPLC is highly predictable. It follows the “Linear Solvent Strength Model (4).” In most cases, the log k (retention factor) of the analyte is inversely proportional to %MPB (mobile phase B or % of the strong organic modifier). In addition, most drugs are basic, but have sufficient hydrophobicity to be retained in RPLC in the ionized forms in acidic mobile phases. The retention of the “solvated” analytes can be manipulated to provide increased resolution by changing the composition of the mobile phase (for example, water, organic solvents, and pH), that interacts with the analytes in the “solvated” state, and moderates their retention on the stationary phase (1,2). Gradient elution is commonly used in stability-indicating assays to yield higher peak capacity and sensitivity for both hydrophilic and hydrophobic components in the sample (2).\n\nThird, most NCEs are chromophoric, having one or more conjugated double bonds or aromatic moieties in their structures, thus providing high detection sensitivity with UV detectors. A peak area precision of 0.1–0.5% relative standard deviation (RSD) is routinely achievable in HPLC-UV assays, because the entire injected sample passes through the UV flow cell. This high precision performance is necessary for quality control applications for DS release testing (with typical specifications of 98.0–102.0%). In contrast, the precision performance of <1% is difficult to achieve with mass spectrometry (MS) detection, because only a small fraction of the nebulized eluent stream is ionized and detected (2). Furthermore, a UV detector offers a wide linear response range exceeding five orders of magnitude (1 x 10-5 to ~2 absorbance units [AU]), allowing the use of a single-point calibration curve for early-phase assays, and normalized area % analysis for the determination of impurities (2).\n\nThere are some notable exceptions to the adoption of RPLC-UV methods. For NCEs with no or low chromophoric properties, a gradient-compatible near-universal detector, such as a charged aerosol detector (CAD) or an evaporative light-scattering detector (ELSD), is typically employed (2). For the determination of enantiomers, a normal-phase separation using chiral LC or supercritical fluid chromatography (SFC) separation, is generally preferred, because the analytes are present in an unassociated and non-ionized state, which often leads to higher selectivity differences between the enantiomers (2).\n\nAnother exception is the determination of potentially genotoxic impurities at parts-per-million levels (not discussed here), which may require a high-sensitivity analytical procedure, such as\nLC with mass spectrometry detection (LC–MS) (2).\n\n\n\nObjectives of This Article\n\nThe objectives of this installment are as follows.\n\nDescribe the traditional five-step strategy in HPLC method development, according to Snyder and associates (1), and illustrate the use of the selectivity-tuning for method optimization with case studies.\n\nDescribe modern HPLC method development trends using ultrahigh-pressure liquid chromatography (UHPLC), MS, automated column or mobile-phase screening systems, and software platform tools.\n\nIntroduce easier or more straight-forward method development approaches, including a three-pronged template for early-phase development and universal generic gradient methods.\n\nDescribe the essential elements of a well-written analytical method, strategies for effective method execution,and the concept of life cycle management of analytical procedures.\n\nThe Traditional Five-Step Method Development Approach\n\nA traditional five-step approach for HPLC method development was proposed by Snyder and associates, based on the concept of selectivity-tuning to increase the resolution of critical pairs (close-eluting peaks) for accurate quantitation (1,2). The five-step approach is outlined here.\n\n\n\nStep 1: Defining Method Types\n\nThe first step is to define the method type. Is it a preparative, qualitative, or quantitative method? The most common method type is a stability-indicating analytical procedure (also known as an assay and impurities determination) for the quantitation of the API and impurities in pharmaceuticals. It is a challenging method development task to develop this type of method, because all key components in the sample must be physically separated in one chromatogram with method performance compliant to ICH guidelines (14). In comparison, other pharmaceutical methods for identification, limit tests, or performance assays, are simpler to develop, validate, and execute. Typically, the DS method is developed first for the NCE, and the DP method is then optimized based on the DS method.\n\n\n\nStep 2: Gathering Sample and Analyte Information\n\nThe next step is to gather information on the sample and analytes. For NCEs, the structures and molecular formulae are well established, allowing the inference or calculation of physicochemical properties, such as pKa, logP, logD, polarity, numbers of acidic, basic, or aromatic functional groups, and chiral centers. These characteristics can be useful in the selection of columns, mobile phases, and sample diluents. The pKa values can be used to select a mobile- phase pH that ensures the compound is in a singly charged state. Knowledge of the acidic, basic, and aromatic functional groups can be helpful in column and mobile-phase selection, and provides forewarnings of potential stability or reactivity issues. Finally, knowing the presence and number of chiral centers is vital for planning an analytical procedure that includes diastereomeric separations. Though not entirely in the scope of this article, possible diastereomeric combinations may be separated with an achiral RPLC column (shown in the case study in Figure 5). Enantiomeric separation offers a different challenge that will require selecting the appropriate chiral-selective column for the determination of enantiomers of the API using a different analytical procedure. To gather analyte information, resources such as Certificate of Analysis (CoA) from suppliers or technical packages from the API manufacturers are invaluable in obtaining initial information regarding sample purity, methodologies, spectral and safety data, and other attributes of the API.\n\n\n\nStep 3: Initial Method Development\n\nThis is the first laboratory-based step in the development process, and it involves performing “scouting” runs to obtain the first chromatograms. Details in column and mobile-phase selection are covered in many books (1–3). To illustrate the initial method development step, we will start here with the most common choice of a C18 column used with an acidified aqueous mobile phase and organic solvent. Step #3, outlined here, is extracted from a case study published in this reference (2).\n\nHere, a sample of the API is dissolved in a default diluent (in this case, 1 mg/mL in 50% acetonitrile in water) and injected into an HPLC-UV system (with a photodiode array (PDA) detector and an MS instrument. A common broad-gradient RPLC method can be used (such as mobile phase A [MPA] = 0.1% formic acid in water; mobile phase B [MPB] = acetonitrile; C18 column: 3-µm, 100 mm x 3.0 mm i.d., 5–100% acetonitrile in 10 min at 1 mL/min and a column temperature at 30 oC). Full spectral data in UV (220–400 nm) and MS (100–1200 amu with positive ionization) are collected to allow reconstruction of chromatograms at any monitoring wavelengths.\n\nIt is important to choose an MS-friendly mobile phase in this step if possible, to reduce the need for any method changes when using MS later. Results from the first scouting run can generate pertinent data, such as a “rough” sample impurity profile, estimation of purity and hydrophobicity of the API, maximum absorbance wavelength (λmax), (M+H)1+ data of the NCE, and any observed impurities. These initial data are used for determining the next logical steps in method fine-tuning.\n\nThe process is often modified for polar or water-soluble NCEs, which may be better retained on an AQ-type-C18 or polar-embedded column (2). For drug candidates with low or no UV chromophoric activities, detectors such as CAD, ELSD, or MS may be employed. One crucial issue in the initial method development of NCEs is the rare availability of an “ideal test mix” sample containing the API and all key impurities or degradation products, deterring a systematic application of automation systems. This dilemma of sample availability will be discussed later.\n\n\n\nStep 4: Method Fine-Tuning and Optimization\n\nThis is the most time-consuming step for the development of stability-indicating procedures. The process is typically reliant on “selectivity tuning” by changing selectivity (α) in a rational fashion by adjusting mobile phases (organic modifier, pH, buffer strength) and operating parameters (flow [F], gradient time [tG], column temperature [T]) (1–3). Often, changing to a column packed with different bonded phases other than C18 may be needed (such as, for example, phenyl, polar-embedded, or cyano) to achieve the separation of a critical pair of coeluting peaks.\n\nThe next step is often to employ a “shallow middle gradient segment” indexed to the hydrophobicity of the API to increase the resolution around the main component (2). This use of a “multi-segment gradient approach” is preferred for complex NCEs and is discussed later.\n\nThe method fine-tuning or optimization process typically takes a few days or 1 to 2 weeks, depending on the complexity of the NCE and the availability of key impurities as reference materials (such as isomers) that are used as retention time markers. This process is often iterative, and is performed before or after the initial forced degradation studies where degradation products are generated to challenge the separation power of the initial method. Peak purity should be evaluated with PDA and MS. Quite often, the initial column used (for example, C18) is found to be inadequate in the separation of a critical pair (for example, API and the immediate synthetic precursor) (2). This would invariably trigger a column screening experiment to find a better column with a different selectivity (for example, phenyl, polar-embedded, or cyano) (2,3). The use of MS can be a valuable tool in column screening, as it can help to track known impurities from column to column as well as degradation products formed during forced degradation studies. Knowledge of the molecular weights helps to determine the molecular structures of the degradation products.\n\nFor laboratories specializing in method development, the use of automated column and mobile-phase screening systems and other software platforms can expedite this time-consuming step. The last steps in the method development phase are the final minor method adjustments needed to improve sensitivity and peak shape (injection volume, sample concentration, diluent, monitoring wavelength), and analysis time.\n\nIt should also be noted that the drug product will also require assays and impurity analysis throughout the life cycle of the NCE. The best and shortest approach to DP method development is to use the chromatographic conditions for the DS with a modified sample preparation procedure.\n\n\n\nStep 5: Method Prequalification\n\nStep 5 for methods used to test regulated products is a method prequalification or prevalidation step. This step will ensure the method can be successfully validated by determining the potential to pass typical method validation criteria (2,16), including specificity, precision, linearity, sensitivity, and often accuracy also. This prequalification step can take from a few hours to 1 or 2 d for most methods.\n\nExamples of the Selectivity Tuning Approach by Changing Mobile Phase, Column, or Both\n\nFigures 1 to 3 show studies of the use of selectivity tuning by changing the mobile phase, column, or both. Figure 1 shows the separation of a 12-component test mixture of basic, acidic, and neutral drugs and the changes in peak spacings with the gradient separation on a C18 column by switching the organic mobile phase (MPB) from methanol to acetonitrile. Note that acetonitrile is a stronger organic modifier in RPLC; thus, the elution time is considerably shorter. The peak shapes are also sharper due to its lower viscosity (1,2). While the elution order remains the same without any peak crossovers, the band spacings are changed due to selectivity differences. Note that acetonitrile is an aprotic solvent, while methanol is capable of hydrogen bonding and polar interaction with the analytes. In cases of analytes that can hydrogen-bond or have polar interaction, the elution order may be different when changing from methanol to acetonitrile.\n\n\n\n\n\nFigure 2 shows eight comparative chromatograms of a 7-component mixture of basic drugs using columns packed with different types of C18, phenyl, cyano, and pentafluorophenyl phases from a single manufacturer. All columns have the same dimension and are packed with similar particle sizes of ~1.7 µm. Chromatograms show similar elution order but with many differences in band spacings for C18 phases, whose predominant retention mechanism is hydrophobic interaction. However, the elution order can be substantially different in columns packed with different bonded phases that have additional retention mechanisms from π-π, polar, and hydrogen bonding interactions. To find the best column for a specific separation, the most efficient approach is to use an automated column and mobile phase screening system (2,3,12).\n\n\n\n\n\nFigure 3 shows two comparative chromatograms in a case study on proactive phase-appropriate method development advocated by Rasmussen and associates (3,17). The top chromatogram shows the separation of a retention marker solution of an API spiked with available impurities that is analyzed by a primary stability-indicating method for a DS method using a C18 column and an MPA at pH 2.5. The bottom chromatogram shows the separation of the same test mix using the secondary orthogonal method on a polar-embedded phase at a neutral MPA pH. More discussion on the development of a secondary orthogonal method is found in a later section.\n\n\n\n\n\nA Summary of Suggested Parameter Selections for Steps 3 and 4\n\nA summary of suggested parameter selections for steps 3 and 4 is listed in Table II as a reference guide for default conditions in HPLC method development for NCEs.\n\n\n\n\n\nDuring the life cycle of any DS or DP, the analytical methods may need to be redeveloped. A new synthetic route or process chemistry changes during scale-up may cause new impurities to be present in the final DS. Also, degradation products found in samples from stability studies may require an improved resolution for quantitation.\n\nMethod Development Approaches and Automation Tools\n\nIn this section, we describe modern approaches in method development and common automated tools for expediting the process. The reader is referred to textbooks, articles, and manufacturers’ websites for updates and more complete descriptions (18–29). Prior to discussing the modern development approaches, let us discuss briefly sample diluent selection for the NCE and sample preparation for DS and DP.\n\nSelection of Sample Diluent and Sample Preparation Procedure\n\nKnowledge about the solubility properties of the API is necessary to choose the most appropriate sample diluent. The most natural choice is to use the initial gradient concentration of the mobile phase. Although this approach may work for hydrophilic or water-soluble compounds, many hydrophobic compounds may not be fully dissolved in these mostly aqueous diluents. Increasing the organic phase concentration may result in full dissolution. However, a higher concentration of organic solvent in the sample diluents may cause chromatographic peak anomaly issues, such as peak splitting upon the injection of large sample volumes (2). Another approach may be the use of a stronger solubilizing agent (such as DMSO), in small concentrations to solubilize the compound and then dilute with the starting concentration of the mobile phase. Often, vigorous shaking manually or with a shaker, or sonication, may be required to expedite the solubilization process. Filtration of a drug substance sample is not recommended since the material must be completely dissolved in a solution for accurate quantitation.\n\nDrug products, such as tablets, also have the added complications of the need to break down the formulation matrix to permit efficient and complete extraction and solubilization of the active ingredients. The separation can be especially problematic upon stability storage due to the aging of the dosage form. Multi-step dilution schemes using shakers or sonication in an appropriate extraction medium followed by filtration (such as 13–25 mm, i.d., 0.2–0.45-µm disposable membrane syringe filters) or centrifugation is generally required to obtain the final sample DP extract for analysis. For sustained-release drug product formulations, a 2-step extraction process is often needed, using an organic solvent to dissolve the polymer-based matrix in the first step. Grinding or rough-crushing the formulation may also be needed to expedite the extraction process. More detailed procedures are available in these references (2,3).\n\nModern Method Development Approaches and Trends\n\nUHPLC\n\nUHPLC is a modern low-dispersion system platform with higher-pressure ratings (15,000–22,500 psi), and is the most significant innovation in HPLC in recent years (18–23). The benefits of UHPLC, when coupled with small-particle columns (sub-2 and sub-3-μm), are faster analysis, enhanced sensitivity, and higher peak capacities for sample analysis (13, 22). The lower system dwell volumes and faster column equilibration times for the smaller UHPLC columns provide another significant benefit for the method development process (12,22). In method optimization, the mobile phase and operating conditions are varied in numerous trial experiments and iterations to optimize the chromatographic behavior of all key analytes to arrive at the optimal separation. The judicious application of UHPLC can reduce method development times by a factor of 3 to 5 in comparison with those obtained with conventional HPLC systems and columns. In addition, UHPLC significantly reduces the amount of solvents used and solvent waste (22).\n\nA potential issue for using UHPLC in method development is the necessity to “back-translate” (also often called “back-transfer” in the literature) or convert the UHPLC methods back to HPLC conditions because many QC laboratories may not be equipped with UHPLC (2,18,23). Today, 16 years after the commercialization of the UHPLC system in 2004 (18), the need for changing the method from UHPLC back to HPLC is lessened by the wider availability of these UHPLC systems (>15,000 psi), and others with intermediary pressures (for example, 9,000–2,000 psi) (19,20).\n\n\n\nMS\n\nWhile most stability-indicating analytical procedures developed for NCEs are HPLC-UV methods, many are also beneficially designed to be MS-compatible using volatile reagents in the mobile phases to allow peak verification, tracking, and identification (2,3). The inclusion of an information-rich MS in the HPLC-UV method development system, in our view, is mandatory for a science-based and efficient method development process, and particularly useful for developing methods of complex NCEs. The MS detector is immensely helpful in the case that the impurities must be identified or qualified.\n\nThe advent of low-cost, easy-to-use single-quadrupole MS (SQMS) makes this adoption much easier for any analytical chemist without specialized MS training (2,19). The only downside is the loss in sensitivity and linear performance for detection wavelength <230 nm due tothe end absorbance of the volatile mobile phase additives (such as formic acid).\n\n\n\nPhase-Appropriate Method Development and Validation\n\nThe concept of “phase-appropriate method development and validation,”’ advocated by H. Rasmussen and associates and others in the early 2000s, recognizes that it is unrealistic to expect the original stability-indicating method for an NCE to remain unchanged during the life cycle of a new drug candidate to commercialization (3,17). It is, therefore, more realistic to have a phase-appropriate or tiered approach, in which the initial method is continuously improved as the formulation is being developed. Complete validation studies are conducted as the project is advancing to late-phase development when the synthetic chemistry process and drug product formulation are finalized.\n\nThe approach recommends the development of a secondary orthogonal method early for several advantages (17). While the word orthogonal separationgenerally means using different retention mechanisms (for example, RPLC based on hydrophobic interaction vs. capillary electrophoresis based on the ionic mobility of the analytes), in reality, most orthogonal methods employ two columns with different selectivity (C18 vs. polar-embedded) or the same column using different organic modifiers (acetonitrile vs. methanol). The secondary orthogonal method ensures that there is no hidden impurities underneath the API peak. It can be used to analyze pivotal clinical lots for supporting data. A minimum method validation can be done to expedite the testing. In addition, the orthogonal method can be used when the primary method is found to be inadequate (such as the inability to resolve a new impurity). This approach can reduce the risk of a potential method deficiency situation, which can have a severe impact on the drug development timeline. Case studies to illustrate this approach are shown in Figures 3 and 5.\n\nApplications of Quality by Design (QbD) and Design of Experiments (DoE) in Method Development\n\nRegulatory authorities have endorsed a science- and risk-based strategy in new drug development, using a systematic Quality by Design (QbD) approach in process development and control of critical raw materials (24). The QbD concept can also be used in method development to establish the capabilities of the method. While a traditional “one-factor-at-a-time”approach is widely practiced in method development, many laboratories have started to use a Design of Experiments (DoE) approach for method robustness validation (3,5). Others have explored the use of automated scouting or screening systems and software platforms for the method development process (2,3,25–27).\n\n\n\nAutomation and Software Platform Systems for Method Development\n\nAlthough most HPLC systems can be post-fitted with selection valves to automate the column/mobile phase screening studies (2,3,12), many manufacturers now offer preconfigured method scouting and screening systems, often with some simple optimization algorithms. They can also work with more elaborate software platforms to facilitate the method development process (2).\n\nTable III lists automated method scouting or screening systems and software platforms for HPLC method development. Many software platforms are available for off-line predictive modeling with inputs from limited experiments (such as DryLab) (2,4,25). Other platforms support direct instrument control and on-line optimization (such as ChromSword Auto and ACD Labs/AutoChrom) and statistical analysis of experimental results (such as Fusion QbD) (2,26–27). The reader is referred to published journal articles and the manufacturers’ websites for further details (25–27).\n\n\n\n\n\nA Dilemma in Early-Phase Method Development\n\nThe use of automated and software systems can expedite the method development process, particularly in laboratories specializing in late-phase product development situations where critical process impurities and degradation products are identified and available as reference materials. This ideal test mix containing all the critical impurities is rarely available during initial method development for an NCE, making it impossible to have a systematic application of automated workflows in early development.\n\nNevertheless, the analytical chemist still needs to have a reasonable first HPLC method to initiate sample evaluation from forced degradation studies. The most realistic scenario is to have proactive communication with the process chemist and to obtain the mother liquors of the final crystallization of the API. As a minimum, a mixture of precursors, starting materials, intermediates from previous synthetic steps, plus any additional reference materials available such as stereoisomers, can be assembled for use as method development samples (3,17).\n\nEasier Approaches to MethodDevelopment for Pharmaceutical Analysis\n\nThe traditional five-step approach with judicious choice of column, detector, and mobile-phase conditions works well for systematic method development for pharmaceutical analysis when implemented by experienced scientists. However, it would be desirable to have easier approaches to develop effective methods by analysts with diverse experience levels. Here we will describe two such approaches.\n\n\n\nA Three-Pronged Template Approach\n\nA three-pronged template approach was proposed in 2013 to facilitate the rapid development of early-phase RPLC methods by recognizing the attributes of the three types of HPLC methods commonly used in the pharmaceutical analysis (10). These method templates, with their unique sets of characteristics and capabilities, allow a quicker method development process for scientists by recognizing the attributes and the expected final method conditions (column, operating conditions). These method templates are described below.\n\nTemplate 1. Fast (sub-2-min) LC isocratic methods for rough assays (potency of DS or strength of DP) used in content uniformity and dissolution (performance) testing of drug products (2). These are non-stability-indicating procedures for the determination of the main component (assay) only. They can be developed and qualified quickly. Note that this method type is not adequate to be used for actual potency assay of a DS or purity factor of a DS on a certificate of analysis (CoA), which must be derived from a validated stability-indicating method or method template #3.\n\n\n\nTemplate 2. Generic broad-gradient RPLC methods can be used for high-throughput screening (1–2 min) (5,28) or in-process control testing (4–10 min) (2,5). Still, the broad gradient RPLC methods can also be re-purposed for purity assays of simpler samples such as raw materials, starting materials, reagents, and cleaning verification (30) samples. The generic methods can be easily modified for stability-indicating assays of simpler drug molecules by extending the gradient times (tG) or using a more complex gradient profile. An organization can adopt a few generic broad-gradient methods for applications across different early development projects to reduce to burden for method development. This practice can save considerable analytical resources, reduce the method development, validation, and transfer time, and the stockpile of different HPLC columns by individual scientists within an organization (29).\n\n\n\nTemplate 3. Multi-segment gradient methods. A brief survey of literature conducted in 2013 indicated a predominance of multi-segment gradient methods for ICH-compliant stability-indicating analytical procedures for complex NCEs (2,10). The rationales for this unique gradient pattern (see Figure 4) are likely to be as follows:\n\n\n\n\n\nIsomers, impurities, and degradants of the API usually have similar structures and hydrophobicity to those of the parent molecule and thus may be eluted close to the API under RPLC.\n\nA shallow gradient with the API eluted toward the end of the gradient segment would maximize the resolution around the API peak. The hydrophobicity of the API defines the final %MPB of this segment.\n\nA steep gradient segment, followed by a purging step, is used to elute highly-retained components (dimers). An initial low-strength gradient segment (starting at 2–5% MPB) may be required to retain polar impurities (such as hydrolytic degradants).\n\n\n\nTraditionally, a single, broad, linear gradient is used during initial method development and column screening. This fast gradient approach is acceptable for initial phase screening but is unlikely to provide sufficient resolution around the API to resolve closely eluted impurities. The understanding of the rationales for the multi-segment gradient program offers helpful insights into the fine-tuning method development steps used in method optimization (step 4). Note that linear gradient segments are invariably used, and isocratic steps should be avoided to reduce method transfer issues between different HPLC or UHPLC systems.\n\nCase Studies to Illustrate the Use of Multi-Segment Gradient Approach for Complex DS and DP Methods\n\nTwo case studies are included here to illustrate the application of this multi-segment gradient approach in the method development of complex pharmaceuticals (13). The third case study is an early UHPLC method development example of an NCE DS method and the “back-transfer” to HPLC conditions (9).\n\n\n\nA Complex NCE with Three Chiral Centers\n\nFigure 5a shows a chromatogram in a method development case study for a complex molecule with three chiral centers. Here, the resolution of the four pairs of diastereomers becomes the crucial criterion for quality assessment (13). The middle gradient segment employed is a shallow gradient (15–40%B in 25 min) used to separate the API (with an absolute configuration of SRR) from its diastereomers (SRS, RRR, and RRS) and other impurities (M416, M456, and M399, designated as their parent (M+H)1+ ions). A low-strength initial gradient allows for the retention of a hydrolytic degradant (M235), while the final segment depicts a steep gradient that elutes any dimers or other late-eluting species. Note that this 42-min HPLC method has been converted into a 17-min UHPLC method using a 100-mm column packed with 2-µm particles with equal resolution performance (13).\n\n\n\n\n\nFigure 5b shows a chromatogram of the secondary orthogonal method developed at the same time, which yields a better resolution of the diastereomers using a phenyl column and methanol. Nevertheless, the HPLC conditions used in Figure 5a with an analysis time of 42 min was employed as the primary regulatory method due to its higher overall resolution and peak capacity. The case study also illustrates the implementation of a proactive method development approach using a secondary orthogonal method to ensure there are no impurities hidden underneath the API peak (2,3).\n\n\n\nA Method for a Complex DP with Multiple APIs\n\nFigure 6 shows a UHPLC-UV chromatogram of a retention marker solution consisting of 60+ components used in a stability-indicating method for a complex DP with four APIs (Strilbild tablet for HIV indication). The method uses a 5-segment linear gradient profile customized to maximize the resolution of the four APIs. The method development process utilized a software-assisted approach using the QbD principle (13,27). This procedure has been successfully validated, and a validation summary data is available from the reference paper (13).\n\n\n\n\n\nAn Early UHPLC Method Development Case Study of an NCE DS Procedure\n\nFigures 7a–d shows a sequence of four chromatograms obtained during an early UHPLC method development case study of an NCE DS method, which has several light degradants published in 2007 (9). Figure 7a shows the original 35-min HPLC chromatogram from a client using a phosphate buffer. This mostly isocratic method was not acceptable because a shoulder “hump” was observed on the downslope of the API peak, indicating the presence of a hidden impurity. Figure 7b shows a 5-min broad-gradient column screening study using a 50-mm C18 column showing an equivalent separation of the original HPLC chromatogram. The entire 4-column screens study took 1 h, indicating a polar-embedded phase (Acquity Shield RP18, 50 x 2.1 mm, 1.7-µm) yielded the best separation around the critical region. MPA was changed to an MS-compatible buffer of 20-mM ammonium format at pH 3.7. Figure 7c shows the final 13-min UHPLC method using an Acquity Shield RP18, 100 x 2.1 mm, 1.7-µm, which yielded an improved resolution of three impurities peaks in the critical region. Figure 7d shows the final 20-min “back-translated” HPLC method using an HPLC column (XBridge Shield RP18, 150 x 3.0 mm, 3.5-µm). This process took 2 d, using principles of “geometric-scaling” (23), assisted by a modeling software (DryLab) to ensure that all three light degradants labeled with an asterisk could be resolved. The entire method development project took about 1 week, including the “back-translation” of the UHPLC method into HPLC conditions.\n\n\n\n\n\nA Modernized Universal Generic Method for Multiple NCEs\n\nWouldn’t it be nice if we could have a single universal generic gradient method that works for multiple NCEs and most pharmaceutical analyses? The concept appeared to work well for cleaning verification when a 10-min HPLC-UV generic method was found suitable for multiple NCEs in a small-molecule portfolio of an organization in 2012 (30). In 2014, the idea was further extended by applying the latest column technologies (short columns packed with sub-3-µm superficially porous particles (SPP) with improved bonded chemistry) to allow the development of a modernized version of a 2-min generic gradient method operating at optimum conditions with simple mobile phases (11).\n\nFigure 8a shows the performance of this modernized generic gradient HPLC-UV–MS method in the separation of a 12-component test mix (11). The method has a peak capacity (Pc) of 100, and resolves ten peaks out a mixture of 12 NCEs with good peak shapes and sensitivity with simple mobile phases on both HPLC and UHPLC systems (3700 psi). Best of all, the “standard” 2-min method can be easily adjusted to resolve all twelve NCEs with a run time of 5 min by simple adjustments of gradient conditions (Figure 8b).\n\n\n\n\n\nThe rationales in the selection of columns, mobile phases, and operating conditions are explained in the 2016 reference (11). This reference also provides several case studies that this generic method can be applied to stability-indicating applications by quick adjustments of gradient conditions (using longer tG and multi-segment gradient) to obtain reasonable initial method conditions. The next steps can be a column or mobile-phase screening and the use of a longer column to arrive at the final regulatory method conditions.\n\nIn summary, a generic gradient method using a short column operating at optimum conditions shown in Figure 8a (for example, C18, 50 mmx 3.0 mm i.d., 2.7-µm SPP, 5 - 60% acetonitrile in 2 min at 1 mL/min) is capable of delivering peak capacities (Pc) of 100-300 in 2 to 10 minutes (2,31–32). The generic method approach works well for cleaning verification of multiple NCEs and provides a useful starting point in the development of stability-indicating analytical procedures.\n\nMethod Content, Execution, and Life Cycle Management\n\nWe devote the final section to discussing the essential elements in a well-written HPLC method (33), guidance in method execution to generate more reliable stability data, and the concept of life cycle management of analytical procedures (34).\n\nMethod Content and Essential Elements in an Analytical Procedure\n\nA well-written analytical procedure with all essential elements is critical for its successful execution of the laboratory. Table IV lists these essential elements for late-stage methods, excerpted from a recent U.S. FDA guidance document (33).\n\n\n\n\n\nIn addition, it is also essential to include as many helpful details in the written method as the analyst will need to successfully execute the method. The method should include example chromatograms (both full- and expanded-scale of a blank, retention marker solution or SSTsolution, standard solution, and a typical sample solution), safety precautions, a table of RRT and RRF if available (2), and method history with reasons for revisions.\n\n\n\nStrategies for Method Execution to Generate Reliable Stability Data\n\nA well-developed and written analytical procedure with full validation and vigorous transfer process is the cornerstone for effective method execution. Understanding the chemistry of the NCE, the physicochemical characteristics of the molecule (such as photosensitivity, hygroscopicity, forms, reactivity, and chirality) and their effects on the stability profile of the DS and DP is crucial. The judicious use of forced degradation and accelerated stability studies, and predictive software models (7) can often reduce the need for conducting more stability studies.\n\nIdeally, the CMC analytical team lead, having intimate knowledge of the drug candidate, should be responsible for the method development and conducting the initial release testing and stability study of the first clinical batches. This work allows a better understanding of the stability profile of the NCE and the nuances in method execution before outsourcing stability studies to external contract organizations. In general, the contract manufacturing organizations (CMOs) selected for the large-scale production of clinical trial materials (CTMs), tend to be preferred partners for conducting stability studies, because they have a higher stake in the success of the development project. It is customary to include shipment of the SST retention marker solutions to the transferred laboratories to lessen the occurrence of peak misidentification caused by retention time peak shifts and potential stability data issues down the line.\n\nLife Cycle Management of Analytical Procedures\n\nThe life cycle management approach can benefit a laboratory and the drug developer by improving the performance of methods, reducing analytical uncertainties such as out-of-specification (OOS) and out-of-trend (OOT) results, and improving the success of the method transfers.\n\nLife cycle management of analytical procedures is an integrated method design, development, and performance characterization strategy based on a structured and systematic approach using concepts of QbD similar to those applied to new drug development (24,34). This approach should be phase appropriate during the early drug substance method development to the final fully validated late-stage drug product methodologies. The strategy starts with the definition of an analytical target profile (ATP)–where the requirements of the analytical procedure (what to measure, method and sample type, separation criteria and performance requirements) for assessing the critical quality attributes (CQAs) of the drug substance and the drug products are described. The three stages of the life cycle are:\n\nStage 1: Method Design and Development\n\nThis stage includes an understanding of the variability of the method, risk assessments, and proposed control strategy for critical method parameters (CMPs) that may pose a risk to consistently achieving method requirements.\n\nStage 2: Method Performance Qualification\n\nThe method, with the proposed control strategy, is qualified to ensure it meets its requirements consistently. This stage includes the method validation process and can be phase appropriate depending on the stage of development.\n\nStage 3: Continued Method Performance Optimization or Verification\n\nThis stage includes monitoring the performance after the method is placed into routine QC use by using control samples and charts as well as evaluation and continuous improvements of the method. The results of method transfer can be part of the performance verification process.\n\nSummary and Conclusions\n\nThis paper provides an overview of the fundamentals and best practices in the development of stability-indicating methods for pharmaceuticals. It describes the traditional five-step method development approach, as well as modern trends, easier approaches, and software tools for expediting the process. The regulatory guidance on a well-written method, strategy for efficient method execution, and life cycle management of analytical procedures are also discussed.\n\nAcknowledgments\n\nThe authors express their gratitude to the following colleagues for their time and efforts to provide timely reviews of the manuscript to improve content accuracy and clarity: Tao Jiang of Mallinckrodt; Anissa Wong and Chris Foti of Gilead Sciences; Mike Shifflet of Johnson and Johnson Consumer Health Care; He Meng of Sanofi; Adrijana Torbovska of Farmahem; Alice Krumenaker of TW Metals, LLC; Mark Shapiro of MCS Pharma Consulting; Szabolcs Fekete of U. Geneva; Deidre Cabooter of KU Leuven; Tamara Andreoli of Medinova AG, Schweiz; Michael DeHart of CMP Pharma; Marc Foster of Mythctest.\n\nReferences\n\nL.R. Snyder, J.J. Kirkland, and J.L. Glajch, Practical HPLC Method Development (John Wiley & Sons, Hoboken, New Jersey, 1997), Chapters 1–2 and 8–9.\n\nM.W. Dong, HPLC and UHPLC for Practicing Scientists, (John Wiley & Sons. Hoboken, New Jersey, 2nd Edition, 2019), Chapters 2–6 and 9–11.\n\nS. Ahuja and M.W. Dong (Eds.), Handbook of Pharmaceutical Analysis by HPLC (Elsevier. Amsterdam, Netherlands, 2005), Chapters 5 and 6.\n\nL.R. Snyder and J.W. Dolan, High-Performance Gradient Elution: The Practical Application of the Linear-Solvent-Strength Model, (Wiley-Interscience, Hoboken, New Jersey, 2007), Chapter 3.\n\nY.V. Kazakevich and R. LoBrutto (Eds.), HPLC for Pharmaceutical Scientists (John Wiley & Sons, Hoboken, New Jersey, 2007), Chapter 8.\n\nK. Huynh-Ba, Ed., Handbook of Stability Testing of Pharmaceutical Products: Regulations, Methodologies, and Best Practices (Springer, New York, New York 2009), Chapter 7.\n\nM.W. Dong, LCGC North Am. 33(11), 764–775 (2015.)\n\nD. Kou, L. Wigman, P. Yehl, and M.W. Dong, LCGC North Am. 33(12), 900–909 (2015).\n\nM.W. Dong, LCGC North Am. 25(7), 656–666 (2007).\n\nM.W. Dong, LCGC North Am. 31(8), 612–622 (2013).\n\nM.W. Dong, LCGC North Am. 34(6), 408–419 (2016)\n\nM.W. Dong and K. Zhang, Trends in Anal. Chem, 63, 21–30 (2014).\n\nM. Dong, D. Guillarme, D. Prudhomme, et al., LCGC North Am. 32(11), 868–876 (2014).\n\nInternational Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use, ICH Q1A (R2), Stability Testing of New Pharmaceutical Products (Geneva, Switzerland, 2003).\n\nInternational Council for Harmonization (ICH) Q14, Analytical Procedure Development, and Revision of Q2(R1) Analytical Validation (Concept Paper), 2018.\n\nInternational Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use, ICH Q2 (R1), Validation of Analytical Procedures: Methodology (Geneva, Switzerland, 1996, updated 2015).\n\nM.W. Dong and H.T. Rasmussen, HPLC Method Development Short Course, Eastern Analytical Symposium, Somerset, New Jersey, 2004.\n\nD. Guillarme and M.W . Dong (Eds.), Trends in Anal. Chem. 63, 1–188 (2014).\n\nV. D’Atri, S. Fekete, A. Clarke, J-L. Veuthey, and Davy Guillarme, Anal. Chem. 91(1), 210–239 (2019).\n\nJ. De Vos, K. Broeckhoven, and S. Eeltink, Anal. Chem. (1), 262–278 (2016).\n\nM.W. Dong, LCGC North Am. 35(6), 374, (2017).\n\nM.W. Dong and D. Guillarme, LCGC North Am. 35(8), 486 (2017).\n\nM.W. Dong, LCGC North Am. 35(11), 818–823 (2017).\n\nInternational Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use, ICH Q8(R2), Pharmaceutical Development (Geneva, Switzerland, 2009).\n\nS. Fekete, J. Fekete, I. Molnár, and K. Ganzier, J. Chromatogr. A 1216(45), 7816–23 (2009).\n\nE.F. Hewitt, P. Lukulay, and S. Galushko, J. Chromatogr. A 1107(1–2), 79–87 (2006).\n\nR.P. Verseput and J. A. Turpin, Chromatography Today, Aug 26, 2015.\n\nM. Wong, B. Murphy, J. H. Pease, and M. W. Dong, LCGC North Am. 33(6), 402 (2015).\n\nM.W. Dong, LCGC North Am. 34(8), 540–545 (2016).\n\nM.W. Dong, E.X. Zhao, D.T. Yazzie, C. C. Gu, and J.D. Pellett, Amer. Pharm. Rev. 15(6), 10–17 (2012).\n\nS. Fekete, D. Guillarme, and M.W. Dong, LCGC North Am. 32(6), 420–433 (2014).\n\nM.W. Dong and B.E. Boyes, LCGC North Am. 36(10), 752–767 (2018).\n\nAnalytical Procedure and Method Validation for Drugs and Biologics: Guidance for Industry (US FDA, CDER and CBER, Pharma Quality/CMC, Silver Spring, Maryland, (2015).\n\nM.K. Parr and A.H. Schmidt, J. Pharm. Biomed. Anal. 147, 506–518 (2018).\n\n\n\n\n\n\n\nMichael W. Dong is a principal of MWD Consulting, which provides training and consulting services in HPLC and UHPLC, method improvements, pharmaceutical analysis, and drug quality. He was formerly a Senior Scientist at Genentech, Research Fellow at Purdue Pharma, and Senior Staff Scientist at Applied Biosystems/PerkinElmer. He holds a PhD in Analytical Chemistry from City University of New York. He has more than 100 publications and a best-selling book in chromatography. He is an editorial advisory board member of LCGC North America and the Chinese American Chromatography Association. Direct correspondence to: LCGCedit@ubm.com \n\n\n\n\n\n\n\nKim Huynh-Ba is the managing director of Pharmalytik LLC. (www.pharmalytik.com), which provides consulting services in stability sciences, quality management systems, and analytical development. She is an Adjunct Professor at Temple University-School of Pharmacy and Illinois Institute of Technology (IIT). Kim is a member of the US Pharmacopeia’s Council of Expert, chairing the Chemical Medicines Monograph IV Expert Committee, USP Good Documentation Practices Expert Panel, USP Organic Impurities of Drug Substance, and Drug Products Expert Panel. She is on the editorial board of the AAPS Open, the Journal of GXP Compliance, and the Journal of Validation Technology. Kim authored ~30 publications and edited two books on stability testing.\n\n\n\n\n\n\n\nJoshua T. Ayers is the Principal Consultant at ASQ Solutions, LLC, which provides analytical, stability, and quality consulting services to the pharmaceutical industry. He has worked on several early and late-stage development projects and marketed products. He has managed analytical laboratories and stability programs for large pharmaceutical companies. Joshua holds a Ph.D. in Medicinal Chemistry from the College of Pharmacy, University of Kentucky. He has authored more than 20 publications and currently sits on the AAPS Stability Community.\n\n","description":"Here we provide an overview of the fundamentals and best practices on the development of stability-indicating HPLC methods for drug substances and products. We explain both traditional and easier modern approaches to developing stability-indicating HPLC methods—including using a universal generic method for new chemical entities—and address regulatory considerations and life cycle management strategies.","author":[{"@type":"Person","name":"Michael W. Dong"},{"@type":"Person","name":"Kim Huynh-Ba"},{"@type":"Person","name":"Joshua T. Ayers"}]}</script></div></div><div class="flex-none w-[300px] z-[9999] relative hidden md:block"><div class="h-full"><div class="sticky top-20"></div></div></div></div><div id="div-gpt-ad-pixel" style="width:1px;height:1px" class=""></div><noscript><iframe src="https://www.googletagmanager.com/ns.html?id=GTM-WL5B9TRW" height="0" width="0" style="display:none;visibility:hidden"></iframe></noscript><div id="footerOuterWrap" class="w-full bg-primary flex flex-col items-center justify-center"><div class="container w-[1340px]"><div id="footerInnerWrap" class="bg-primary w-full py-12"><div class="py-4 pl-4 flex flex-row items-center"><div class="flex flex-row flex-wrap w-[55%] h-full"><div class="w-[33%] p-1 my-0 cursor-pointer text-footer-text-color hover:text-footer-text-color/80 hover:underline"><a class="text-md" target="_self" href="/view/about-lcgc">About</a></div><div class="w-[33%] p-1 my-0 cursor-pointer text-footer-text-color hover:text-footer-text-color/80 hover:underline"><a 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Columnist Michael W. Dong is a principal at MWD Consulting, where he provides training and consulting services in HPLC, UHPLC, pharmaceutical analysis, and drug quality. He was formerly a senior scientist at Genentech, a research fellow at Purdue Pharma, and senior staff scientist at Applied Biosystems/PerkinElmer.","_key":"a80c2af33e74"},{"_type":"span","marks":["12052a20162c","7a850ccc8794"],"text":"","_key":"4585bcd5966b"}]},{"markDefs":[{"_key":"69dc8ed89eef","_type":"link","href":"https://www.chromatographyonline.com/columns/column-perspectives-modern-hplc"}],"children":[{"text":"","_key":"c45ffee56ceb","_type":"span","marks":["12052a20162c","7a850ccc8794"]},{"_type":"span","marks":[],"text":"","_key":"1c223d8da3c1"},{"_type":"span","marks":["077be5f4d92c","69dc8ed89eef"],"text":"View Articles","_key":"dc30b2316e8c0"},{"_type":"span","marks":[],"text":"","_key":"07bd074fc320"}],"_type":"block","style":"normal","_key":"049e045dd0d1"}],"_updatedAt":"2023-02-02T16:57:58Z","sortOrder":7,"pixelTrackingCode":null,"name":"Column: Perspectives in Modern HPLC","thumbnail":{"asset":{"_ref":"image-81cf69ed6f838d47000f016797c0ed0620f71503-250x262-png","_type":"reference"},"_type":"mainImage"}},"_updatedAt":"2021-08-24T17:28:31Z","summary":"Here we provide an overview of the fundamentals and best practices on the development of stability-indicating HPLC methods for drug substances and products. We explain both traditional and easier modern approaches to developing stability-indicating HPLC methods—including using a universal generic method for new chemical entities—and address regulatory considerations and life cycle management strategies.","contentCategory":{"_id":"8bdaa7fc-960a-4b57-b076-75fdce3741bb","name":"Articles"},"contentGroup":null,"factCheckAuthorMapping":null,"issueGroup":{"thumbnail":{"asset":{"_ref":"image-8ba74e81991d36658703c5f0ab76d9ac6b24cdc4-2324x3147-jpg","_type":"reference"},"_type":"mainImage"},"source":"LCGC North America","parent":{"_rev":"BF7atoIeGqveHbKHSXGS2J","is_visible":true,"_createdAt":"2020-06-26T08:32:37Z","parent":null,"_type":"publication","name":"LCGC North 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Direct correspondence to: "},{"_key":"0072589670d2","_type":"span","marks":["a886a0a36382"],"text":"LCGCedit@mmhgroup.com"},{"text":".","_key":"6963d48e9164","_type":"span","marks":[]}],"_type":"block"}]},{"firstName":"Kim","lastName":"Huynh-Ba","displayName":"Kim Huynh-Ba","_id":"5398bf74-57a2-4cb7-9a49-f451fe91a08f","url":{"current":"kim-huynh-ba","_type":"slug"},"_createdAt":"2020-09-08T18:58:24Z","_rev":"kHSAga6vQdrwoTeQT6kl6K","_type":"author","_updatedAt":"2020-09-08T18:58:24Z"},{"_rev":"4ZuyxDEmzwMm18OIMMl2MI","_id":"6aea26b9-f6c6-4afc-98a2-8c4955b5a7d7","_updatedAt":"2020-09-08T18:59:04Z","url":{"current":"joshua-t.-ayers","_type":"slug"},"firstName":"Joshua","_createdAt":"2020-09-08T18:59:04Z","_type":"author","middleName":"T.","lastName":"Ayers","displayName":"Joshua T. Ayers"}],"taxonomyMapping":[{"parent":{"_createdAt":"2020-07-15T15:48:03Z","_id":"chroma_taxonomy_38471_topic","_updatedAt":"2023-09-20T16:52:32Z","identifier":"topic","name":"Topic","parent":null,"isMainTopic":true,"_rev":"J34BMvlUIWrjsIqgLxmpXQ","_type":"taxonomy"},"_createdAt":"2020-07-15T15:48:03Z","_type":"taxonomy","name":"HPLC","_updatedAt":"2020-08-01T11:11:48Z","pixelTrackingCode":null,"identifier":"topic/hplc","_rev":"4Q6wgk7hVHKTxcqSyD1Qm2","_id":"chroma_taxonomy_2800_hplc"},{"identifier":"topic/pharmaceutical-analysis-2","_type":"taxonomy","_id":"chroma_taxonomy_38290_pharmaceuticalanalysis","_updatedAt":"2020-08-01T11:11:48Z","pixelTrackingCode":null,"parent":{"parent":null,"_createdAt":"2020-07-15T15:48:03Z","_rev":"J34BMvlUIWrjsIqgLxmpXQ","_type":"taxonomy","_id":"chroma_taxonomy_38471_topic","_updatedAt":"2023-09-20T16:52:32Z","identifier":"topic","name":"Topic","isMainTopic":true},"_createdAt":"2020-07-15T15:48:03Z","_rev":"4Q6wgk7hVHKTxcqSyD1Qoj","name":"Pharmaceutical Analysis"}],"seo":{"_type":"seo-tools","focus_keyword":"stability","seo_title":"Development Stability-Indicating Analytical Procedures HPLC"},"_type":"article","seoTag":["Perspectives","HPLC","methods"],"showSocialShare":true,"published":"2020-08-01T04:00:00.000Z","thumbnail":{"hotspot":{"height":1,"_type":"sanity.imageHotspot","width":0.9980769230769231,"x":0.5009615384615385,"y":0.5},"_type":"mainImage","asset":{"_type":"reference","_ref":"image-78e8a3bd7de9cfb62a1bbc26d7b392653c04a3b2-11367x3736-jpg"},"crop":{"top":0,"left":0.0019230769230769232,"bottom":0,"_type":"sanity.imageCrop","right":0}},"body":[{"_key":"44b2572e5015","markDefs":[],"children":[{"_type":"span","marks":["strong"],"text":"This installment is the second in a series of three white papers on stability studies and testing of pharmaceuticals. It focuses on the development of stability-indicating high performance liquid chromatography (HPLC) methods for drug substances and products. This paper provides an overview of the fundamentals and best practices in method development, including the traditional and other easier approaches, as well as modern trends and software tools for expediting the process. The regulatory guidance on the necessary contents of a well-written method, strategies for efficient method execution, and life cycle management of analytical procedures, are described.","_key":"17da8b64a89c"}],"_type":"block","upload_doc":null,"uploadAudio":null,"medias":null,"style":"normal"},{"markDefs":[],"children":[{"_type":"span","marks":[],"text":"High performance liquid chromatography (HPLC) method development can be a time-consuming process, particularly for stability-indicating analytical procedures of new chemical entities (NCEs). Most of the procedures for small-molecule drugs employ gradient reversed-phase liquid chromatography (RPLC) with ultraviolet (UV) detection. These methods are designed to separate and quantitate the active pharmaceutical ingredients (APIs) and all process impurities and degradation products in drug substance (DS) and drug product (DP) samples. This important HPLC method category provides quality assessment data required in product release and stability studies in regulatory filings and procedures (Table I). Information on the HPLC method development process and requirements are available in many textbooks (1–6), journal articles (7–13), regulatory guidance documents (14–16), and other resources (17). In this installment, we strive to provide a concise but comprehensive overview of the essential steps of the method development process, supported with case studies, common practices, regulatory guidance, and citations of critical references.","_key":"e113439236760"}],"_type":"block","style":"normal","upload_doc":null,"uploadAudio":null,"medias":null,"_key":"36f03f8ecc0e"},{"_key":"f4bd507d5733","markDefs":[],"children":[{"_type":"span","marks":[],"text":"","_key":"f9a357602947"}],"upload_doc":null,"uploadAudio":null,"medias":null,"_type":"block","style":"normal"},{"uploadAudio":null,"medias":null,"blank":true,"_type":"figure","_key":"b21c4e1438c1","asset":{"_ref":"image-631870c2ecf2aef2c70a58d47b5309b9c1905e66-630x737-jpg","_type":"reference"},"upload_doc":null},{"children":[{"_type":"span","marks":["strong"],"text":"Why Gradient RPLC with UV Detection for Stability-Indicating Methods?","_key":"35999dd8af440"}],"upload_doc":null,"uploadAudio":null,"medias":null,"_type":"block","style":"normal","_key":"1b0dd087aa81","markDefs":[]},{"_key":"f05af6859be1","markDefs":[],"children":[{"_key":"224deb88dbb60","_type":"span","marks":[],"text":"Let us start with the fundamentals and the rationale for the use of RPLC and UV methods in stability-indicating analytical procedures, which must separate the API from all impurities, and meet stringent regulatory requirements in method performance (6,14–16)."}],"_type":"block","upload_doc":null,"uploadAudio":null,"medias":null,"style":"normal"},{"_key":"d2be3a402711","markDefs":[],"children":[{"marks":[],"text":"First, the primary retention mechanism in RPLC is hydrophobic interaction, particularly useful for compounds with intermediate polarities, and an excellent match of most small-molecule drugs with oral bioavailability (2). The weak dispersive forces in RPLC ensure that all components in the sample can be eluted from the column using strong purging solvents at the end of the gradient, thus yielding 100% recovery of the injected sample.","_key":"4c38069884bc0","_type":"span"}],"_type":"block","style":"normal","upload_doc":null,"uploadAudio":null,"medias":null},{"uploadAudio":null,"medias":null,"markDefs":[],"children":[{"_type":"span","marks":[],"text":"Second, the elution order in RPLC is highly predictable. It follows the “Linear Solvent Strength Model (4).” In most cases, the log ","_key":"ee8749089a0b0"},{"_type":"span","marks":["em"],"text":"k","_key":"ee8749089a0b1"},{"marks":[],"text":" (retention factor) of the analyte is inversely proportional to %MPB (mobile phase B or % of the strong organic modifier). In addition, most drugs are basic, but have sufficient hydrophobicity to be retained in RPLC in the ionized forms in acidic mobile phases. The retention of the “solvated” analytes can be manipulated to provide increased resolution by changing the composition of the mobile phase (for example, water, organic solvents, and pH), that interacts with the analytes in the “solvated” state, and moderates their retention on the stationary phase (1,2). Gradient elution is commonly used in stability-indicating assays to yield higher peak capacity and sensitivity for both hydrophilic and hydrophobic components in the sample (2).","_key":"ee8749089a0b2","_type":"span"}],"_type":"block","style":"normal","_key":"5bdc20f6335c","upload_doc":null},{"_type":"block","style":"normal","_key":"bfcc6ae46e5f","markDefs":[],"upload_doc":null,"uploadAudio":null,"medias":null,"children":[{"_type":"span","marks":[],"text":"Third, most NCEs are chromophoric, having one or more conjugated double bonds or aromatic moieties in their structures, thus providing high detection sensitivity with UV detectors. A peak area precision of 0.1–0.5% relative standard deviation (RSD) is routinely achievable in HPLC-UV assays, because the entire injected sample passes through the UV flow cell. This high precision performance is necessary for quality control applications for DS release testing (with typical specifications of 98.0–102.0%). In contrast, the precision performance of \u003c1% is difficult to achieve with mass spectrometry (MS) detection, because only a small fraction of the nebulized eluent stream is ionized and detected (2). Furthermore, a UV detector offers a wide linear response range exceeding five orders of magnitude (1 x 10-5 to ~2 absorbance units [AU]), allowing the use of a single-point calibration curve for early-phase assays, and normalized area % analysis for the determination of impurities (2).","_key":"b6b7eb45af880"}]},{"style":"normal","_key":"3a0ab917a626","markDefs":[],"children":[{"_type":"span","marks":[],"text":"There are some notable exceptions to the adoption of RPLC-UV methods. For NCEs with no or low chromophoric properties, a gradient-compatible near-universal detector, such as a charged aerosol detector (CAD) or an evaporative light-scattering detector (ELSD), is typically employed (2). For the determination of enantiomers, a normal-phase separation using chiral LC or supercritical fluid chromatography (SFC) separation, is generally preferred, because the analytes are present in an unassociated and non-ionized state, which often leads to higher selectivity differences between the enantiomers (2).","_key":"48ce3f95c0250"}],"_type":"block","upload_doc":null,"uploadAudio":null,"medias":null},{"children":[{"_type":"span","marks":[],"text":"Another exception is the determination of potentially genotoxic impurities at parts-per-million levels (not discussed here), which may require a high-sensitivity analytical procedure, such as\nLC with mass spectrometry detection (LC–MS) (2).","_key":"6cf1fe2611ce0"}],"_type":"block","style":"normal","_key":"8c828db25dbf","upload_doc":null,"uploadAudio":null,"medias":null,"markDefs":[]},{"_type":"block","style":"normal","upload_doc":null,"uploadAudio":null,"medias":null,"_key":"ab0988efb7b2","markDefs":[],"children":[{"_type":"span","marks":[],"text":"","_key":"27d7ac768fec0"}]},{"upload_doc":null,"uploadAudio":null,"medias":null,"style":"normal","_key":"0fe5f6440d2f","markDefs":[],"children":[{"_type":"span","marks":["strong"],"text":"Objectives of This Article","_key":"0d3dbe6f84fe0"}],"_type":"block"},{"uploadAudio":null,"medias":null,"markDefs":[],"children":[{"_key":"fe68a0c3bc9b0","_type":"span","marks":[],"text":"The objectives of this installment are as follows."}],"_type":"block","style":"normal","_key":"2014f77cffb3","upload_doc":null},{"_type":"block","style":"normal","_key":"3f309341f539","markDefs":[],"children":[{"_type":"span","marks":[],"text":"Describe the traditional five-step strategy in HPLC method development, according to Snyder and associates (1), and illustrate the use of the selectivity-tuning for method optimization with case studies.","_key":"9de1ad7325ca0"}],"upload_doc":null,"uploadAudio":null,"medias":null},{"_type":"block","style":"normal","_key":"059d91e74d41","markDefs":[],"children":[{"_type":"span","marks":[],"text":"Describe modern HPLC method development trends using ultrahigh-pressure liquid chromatography (UHPLC), MS, automated column or mobile-phase screening systems, and software platform tools.","_key":"13e77c4e8dce0"}],"upload_doc":null,"uploadAudio":null,"medias":null},{"upload_doc":null,"uploadAudio":null,"medias":null,"_key":"dc2756e887c2","markDefs":[],"children":[{"_type":"span","marks":[],"text":"Introduce easier or more straight-forward method development approaches, including a three-pronged template for early-phase development and universal generic gradient methods.","_key":"da6ad54910c30"}],"_type":"block","style":"normal"},{"uploadAudio":null,"medias":null,"markDefs":[],"children":[{"marks":[],"text":"Describe the essential elements of a well-written analytical method, strategies for effective method execution,and the concept of life cycle management of analytical procedures.","_key":"fcf87ef289440","_type":"span"}],"_type":"block","style":"normal","_key":"9681d08b2926","upload_doc":null},{"upload_doc":null,"uploadAudio":null,"medias":null,"children":[{"_type":"span","marks":["strong"],"text":"The Traditional Five-Step Method Development Approach","_key":"8070d8aaeb430"}],"_type":"block","style":"normal","_key":"0fb11b733a30","markDefs":[]},{"uploadAudio":null,"medias":null,"_key":"ede61832d43a","markDefs":[],"children":[{"_type":"span","marks":[],"text":"A traditional five-step approach for HPLC method development was proposed by Snyder and associates, based on the concept of selectivity-tuning to increase the resolution of critical pairs (close-eluting peaks) for accurate quantitation (1,2). The five-step approach is outlined here.","_key":"6076365d95450"}],"_type":"block","style":"normal","upload_doc":null},{"_type":"block","style":"normal","_key":"54bc5e5db165","markDefs":[],"children":[{"_type":"span","marks":[],"text":"","_key":"95123668da0f0"}],"upload_doc":null,"uploadAudio":null,"medias":null},{"uploadAudio":null,"medias":null,"children":[{"text":"Step 1: Defining Method Types","_key":"41579ad9c5000","_type":"span","marks":["strong"]}],"_type":"block","style":"normal","_key":"e9be46e5ed60","markDefs":[],"upload_doc":null},{"uploadAudio":null,"medias":null,"children":[{"marks":[],"text":"The first step is to define the method type. Is it a preparative, qualitative, or quantitative method? The most common method type is a stability-indicating analytical procedure (also known as an ","_key":"2063c08d94db0","_type":"span"},{"_type":"span","marks":["em"],"text":"assay and impurities determination","_key":"2063c08d94db1"},{"_type":"span","marks":[],"text":") for the quantitation of the API and impurities in pharmaceuticals. It is a challenging method development task to develop this type of method, because all key components in the sample must be physically separated in one chromatogram with method performance compliant to ICH guidelines (14). In comparison, other pharmaceutical methods for identification, limit tests, or performance assays, are simpler to develop, validate, and execute. Typically, the DS method is developed first for the NCE, and the DP method is then optimized based on the DS method.","_key":"2063c08d94db2"}],"_type":"block","style":"normal","_key":"fcc5ad7bb327","markDefs":[],"upload_doc":null},{"uploadAudio":null,"medias":null,"_key":"6d7ab8bc8c49","markDefs":[],"children":[{"text":"","_key":"ddedb67721810","_type":"span","marks":[]}],"_type":"block","style":"normal","upload_doc":null},{"markDefs":[],"children":[{"text":"Step 2: Gathering Sample and Analyte Information","_key":"b90b121bd88a0","_type":"span","marks":["strong"]}],"_type":"block","upload_doc":null,"uploadAudio":null,"medias":null,"style":"normal","_key":"b67ffc2ca173"},{"medias":null,"_key":"ea2122c9a21a","markDefs":[],"children":[{"marks":[],"text":"The next step is to gather information on the sample and analytes. For NCEs, the structures and molecular formulae are well established, allowing the inference or calculation of physicochemical properties, such as ","_key":"749fdff056060","_type":"span"},{"_type":"span","marks":["em"],"text":"pK","_key":"749fdff056061"},{"_type":"span","marks":[],"text":"a, log","_key":"749fdff056062"},{"_type":"span","marks":["em"],"text":"P","_key":"749fdff056063"},{"_type":"span","marks":[],"text":", log","_key":"749fdff056064"},{"_key":"749fdff056065","_type":"span","marks":["em"],"text":"D"},{"marks":[],"text":", polarity, numbers of acidic, basic, or aromatic functional groups, and chiral centers. These characteristics can be useful in the selection of columns, mobile phases, and sample diluents. The ","_key":"749fdff056066","_type":"span"},{"marks":["em"],"text":"pK","_key":"749fdff056067","_type":"span"},{"_type":"span","marks":[],"text":"a values can be used to select a mobile- phase pH that ensures the compound is in a singly charged state. Knowledge of the acidic, basic, and aromatic functional groups can be helpful in column and mobile-phase selection, and provides forewarnings of potential stability or reactivity issues. Finally, knowing the presence and number of chiral centers is vital for planning an analytical procedure that includes diastereomeric separations. Though not entirely in the scope of this article, possible diastereomeric combinations may be separated with an achiral RPLC column (shown in the case study in Figure 5). Enantiomeric separation offers a different challenge that will require selecting the appropriate chiral-selective column for the determination of enantiomers of the API using a different analytical procedure. To gather analyte information, resources such as Certificate of Analysis (CoA) from suppliers or technical packages from the API manufacturers are invaluable in obtaining initial information regarding sample purity, methodologies, spectral and safety data, and other attributes of the API.","_key":"749fdff056068"}],"_type":"block","style":"normal","upload_doc":null,"uploadAudio":null},{"uploadAudio":null,"medias":null,"markDefs":[],"children":[{"_type":"span","marks":[],"text":"","_key":"71784a91fb2a0"}],"_type":"block","style":"normal","_key":"46d6ed4a2369","upload_doc":null},{"children":[{"_type":"span","marks":["strong"],"text":"Step 3: Initial Method Development","_key":"6d89211def630"}],"_type":"block","style":"normal","upload_doc":null,"uploadAudio":null,"medias":null,"_key":"174c71c8a8d8","markDefs":[]},{"style":"normal","_key":"234574b0ca00","markDefs":[],"children":[{"marks":[],"text":"This is the first laboratory-based step in the development process, and it involves performing “scouting” runs to obtain the first chromatograms. Details in column and mobile-phase selection are covered in many books (1–3). To illustrate the initial method development step, we will start here with the most common choice of a C18 column used with an acidified aqueous mobile phase and organic solvent. Step #3, outlined here, is extracted from a case study published in this reference (2).","_key":"d36915d0d3200","_type":"span"}],"_type":"block","upload_doc":null,"uploadAudio":null,"medias":null},{"style":"normal","_key":"e7d0d630be14","markDefs":[],"children":[{"_type":"span","marks":[],"text":"Here, a sample of the API is dissolved in a default diluent (in this case, 1 mg/mL in 50% acetonitrile in water) and injected into an HPLC-UV system (with a photodiode array (PDA) detector and an MS instrument. A common broad-gradient RPLC method can be used (such as mobile phase A [MPA] = 0.1% formic acid in water; mobile phase B [MPB] = acetonitrile; C18 column: 3-µm, 100 mm x 3.0 mm i.d., 5–100% acetonitrile in 10 min at 1 mL/min and a column temperature at 30 oC). Full spectral data in UV (220–400 nm) and MS (100–1200 amu with positive ionization) are collected to allow reconstruction of chromatograms at any monitoring wavelengths.","_key":"439ac07032240"}],"_type":"block","upload_doc":null,"uploadAudio":null,"medias":null},{"children":[{"_type":"span","marks":[],"text":"It is important to choose an MS-friendly mobile phase in this step if possible, to reduce the need for any method changes when using MS later. Results from the first scouting run can generate pertinent data, such as a “rough” sample impurity profile, estimation of purity and hydrophobicity of the API, maximum absorbance wavelength (","_key":"154955983e650"},{"_type":"span","marks":["em"],"text":"λ","_key":"154955983e651"},{"_type":"span","marks":[],"text":"max), (M+H)1+ data of the NCE, and any observed impurities. These initial data are used for determining the next logical steps in method fine-tuning.","_key":"154955983e652"}],"_type":"block","style":"normal","_key":"a3ca4f63842d","upload_doc":null,"uploadAudio":null,"medias":null,"markDefs":[]},{"medias":null,"children":[{"marks":[],"text":"The process is often modified for polar or water-soluble NCEs, which may be better retained on an AQ-type-C18 or polar-embedded column (2). For drug candidates with low or no UV chromophoric activities, detectors such as CAD, ELSD, or MS may be employed. One crucial issue in the initial method development of NCEs is the rare availability of an “ideal test mix” sample containing the API and all key impurities or degradation products, deterring a systematic application of automation systems. This dilemma of sample availability will be discussed later.","_key":"ab9cf1264fee0","_type":"span"}],"_type":"block","style":"normal","_key":"bb582d8071e7","markDefs":[],"upload_doc":null,"uploadAudio":null},{"children":[{"_type":"span","marks":[],"text":"","_key":"f587161322dc0"}],"_type":"block","upload_doc":null,"uploadAudio":null,"medias":null,"style":"normal","_key":"8031752700bc","markDefs":[]},{"medias":null,"children":[{"_type":"span","marks":["strong"],"text":"Step 4: Method Fine-Tuning and Optimization","_key":"1cbd813b0a960"}],"_type":"block","style":"normal","_key":"3678c0babb52","markDefs":[],"upload_doc":null,"uploadAudio":null},{"medias":null,"_key":"95b424dad988","markDefs":[],"children":[{"_key":"221783a5e4450","_type":"span","marks":[],"text":"This is the most time-consuming step for the development of stability-indicating procedures. The process is typically reliant on “selectivity tuning” by changing selectivity ("},{"_type":"span","marks":["em"],"text":"α","_key":"221783a5e4451"},{"_type":"span","marks":[],"text":") in a rational fashion by adjusting mobile phases (organic modifier, pH, buffer strength) and operating parameters (flow [","_key":"221783a5e4452"},{"text":"F","_key":"221783a5e4453","_type":"span","marks":["em"]},{"_key":"221783a5e4454","_type":"span","marks":[],"text":"], gradient time ["},{"_type":"span","marks":["em"],"text":"t","_key":"221783a5e4455"},{"marks":[],"text":"G], column temperature [","_key":"221783a5e4456","_type":"span"},{"_type":"span","marks":["em"],"text":"T","_key":"221783a5e4457"},{"_type":"span","marks":[],"text":"]) (1–3). Often, changing to a column packed with different bonded phases other than C18 may be needed (such as, for example, phenyl, polar-embedded, or cyano) to achieve the separation of a critical pair of coeluting peaks.","_key":"221783a5e4458"}],"_type":"block","style":"normal","upload_doc":null,"uploadAudio":null},{"upload_doc":null,"uploadAudio":null,"medias":null,"markDefs":[],"children":[{"_type":"span","marks":[],"text":"The next step is often to employ a “shallow middle gradient segment” indexed to the hydrophobicity of the API to increase the resolution around the main component (2). This use of a “multi-segment gradient approach” is preferred for complex NCEs and is discussed later.","_key":"df89a1a160480"}],"_type":"block","style":"normal","_key":"31321c18eda8"},{"children":[{"marks":[],"text":"The method fine-tuning or optimization process typically takes a few days or 1 to 2 weeks, depending on the complexity of the NCE and the availability of key impurities as reference materials (such as isomers) that are used as retention time markers. This process is often iterative, and is performed before or after the initial forced degradation studies where degradation products are generated to challenge the separation power of the initial method. Peak purity should be evaluated with PDA and MS. Quite often, the initial column used (for example, C18) is found to be inadequate in the separation of a critical pair (for example, API and the immediate synthetic precursor) (2). This would invariably trigger a column screening experiment to find a better column with a different selectivity (for example, phenyl, polar-embedded, or cyano) (2,3). The use of MS can be a valuable tool in column screening, as it can help to track known impurities from column to column as well as degradation products formed during forced degradation studies. Knowledge of the molecular weights helps to determine the molecular structures of the degradation products.","_key":"a49b1fc0d18b0","_type":"span"}],"_type":"block","style":"normal","_key":"be83003751da","markDefs":[],"upload_doc":null,"uploadAudio":null,"medias":null},{"_type":"block","upload_doc":null,"uploadAudio":null,"medias":null,"style":"normal","_key":"495201a53b8f","markDefs":[],"children":[{"text":"For laboratories specializing in method development, the use of automated column and mobile-phase screening systems and other software platforms can expedite this time-consuming step. The last steps in the method development phase are the final minor method adjustments needed to improve sensitivity and peak shape (injection volume, sample concentration, diluent, monitoring wavelength), and analysis time.","_key":"616c63e66cba0","_type":"span","marks":[]}]},{"medias":null,"style":"normal","_key":"117694f7bebd","markDefs":[],"children":[{"_key":"0c9c23e03ac30","_type":"span","marks":[],"text":"It should also be noted that the drug product will also require assays and impurity analysis throughout the life cycle of the NCE. The best and shortest approach to DP method development is to use the chromatographic conditions for the DS with a modified sample preparation procedure."}],"_type":"block","upload_doc":null,"uploadAudio":null},{"upload_doc":null,"uploadAudio":null,"medias":null,"children":[{"_type":"span","marks":[],"text":"","_key":"a7059b60359f0"}],"_type":"block","style":"normal","_key":"8cf2bfbb9b11","markDefs":[]},{"_type":"block","style":"normal","_key":"6b09ac5359ad","markDefs":[],"children":[{"_key":"b059751729440","_type":"span","marks":["strong"],"text":"Step 5: Method Prequalification"}],"upload_doc":null,"uploadAudio":null,"medias":null},{"medias":null,"markDefs":[],"children":[{"_type":"span","marks":[],"text":"Step 5 for methods used to test regulated products is a method prequalification or prevalidation step. This step will ensure the method can be successfully validated by determining the potential to pass typical method validation criteria (2,16), including specificity, precision, linearity, sensitivity, and often accuracy also. This prequalification step can take from a few hours to 1 or 2 d for most methods.","_key":"57ff0d197c2c0"}],"_type":"block","style":"normal","_key":"ad4cdde1c11a","upload_doc":null,"uploadAudio":null},{"uploadAudio":null,"medias":null,"style":"normal","_key":"7e75ae909f3c","markDefs":[],"children":[{"text":"Examples of the Selectivity Tuning Approach by Changing Mobile Phase, Column, or Both","_key":"813e894ef7eb0","_type":"span","marks":["strong"]}],"_type":"block","upload_doc":null},{"style":"normal","upload_doc":null,"uploadAudio":null,"medias":null,"_key":"8a3d8dfbdbfb","markDefs":[],"children":[{"_type":"span","marks":[],"text":"Figures 1 to 3 show studies of the use of selectivity tuning by changing the mobile phase, column, or both. Figure 1 shows the separation of a 12-component test mixture of basic, acidic, and neutral drugs and the changes in peak spacings with the gradient separation on a C18 column by switching the organic mobile phase (MPB) from methanol to acetonitrile. Note that acetonitrile is a stronger organic modifier in RPLC; thus, the elution time is considerably shorter. The peak shapes are also sharper due to its lower viscosity (1,2). While the elution order remains the same without any peak crossovers, the band spacings are changed due to selectivity differences. Note that acetonitrile is an aprotic solvent, while methanol is capable of hydrogen bonding and polar interaction with the analytes. In cases of analytes that can hydrogen-bond or have polar interaction, the elution order may be different when changing from methanol to acetonitrile.","_key":"336cbf6b21bb0"}],"_type":"block"},{"upload_doc":null,"uploadAudio":null,"medias":null,"_key":"ae15e853db35","markDefs":[],"children":[{"_type":"span","marks":[],"text":"","_key":"601ada52160b"}],"_type":"block","style":"normal"},{"_key":"8ad7f4f001b1","asset":{"_ref":"image-9f9a18dee59169b7e0c20e1bd32d036e32258f4e-3215x1850-jpg","_type":"reference"},"upload_doc":null,"uploadAudio":null,"medias":null,"blank":true,"_type":"figure","caption":"Figure 1: The comparative chromatograms illustrate the use of selectivity tuning by different organic solvents. Chromatograms courtesy of Waters Corporation."},{"_key":"d5eff84a17e2","markDefs":[],"children":[{"_type":"span","marks":[],"text":"Figure 2 shows eight comparative chromatograms of a 7-component mixture of basic drugs using columns packed with different types of C18, phenyl, cyano, and pentafluorophenyl phases from a single manufacturer. All columns have the same dimension and are packed with similar particle sizes of ~1.7 µm. Chromatograms show similar elution order but with many differences in band spacings for C18 phases, whose predominant retention mechanism is hydrophobic interaction. However, the elution order can be substantially different in columns packed with different bonded phases that have additional retention mechanisms from π-π, polar, and hydrogen bonding interactions. To find the best column for a specific separation, the most efficient approach is to use an automated column and mobile phase screening system (2,3,12).","_key":"deb33b50d8d20"}],"_type":"block","upload_doc":null,"uploadAudio":null,"medias":null,"style":"normal"},{"upload_doc":null,"uploadAudio":null,"medias":null,"children":[{"text":"","_key":"6d658d8a5853","_type":"span","marks":[]}],"_type":"block","style":"normal","_key":"e6d48babd844","markDefs":[]},{"upload_doc":null,"uploadAudio":null,"medias":null,"caption":"Figure 2: Comparative chromatograms of the gradient separations of a test mix containing seven basic drugs, illustrating the effect of selectivity of bonded phases (C18, phenyl, cyano, pentafluorophenyl [PFP]). All columns are 50 x 2.1 mm, 1.7-µm, with 10-mM ammonium formate at pH 3, and the same linear gradient with methanol. Diagram courtesy of Waters Corporation.","_key":"e31a5f5c8cc5","asset":{"_ref":"image-99f4daf89c7300a79a894aa2f0513b90f4fc6b04-3128x1851-jpg","_type":"reference"},"blank":true,"_type":"figure"},{"upload_doc":null,"uploadAudio":null,"medias":null,"markDefs":[],"children":[{"_type":"span","marks":[],"text":"Figure 3 shows two comparative chromatograms in a case study on proactive phase-appropriate method development advocated by Rasmussen and associates (3,17). The top chromatogram shows the separation of a retention marker solution of an API spiked with available impurities that is analyzed by a primary stability-indicating method for a DS method using a C18 column and an MPA at pH 2.5. The bottom chromatogram shows the separation of the same test mix using the secondary orthogonal method on a polar-embedded phase at a neutral MPA pH. More discussion on the development of a secondary orthogonal method is found in a later section.","_key":"1e8e6ed990e10"}],"_type":"block","style":"normal","_key":"988275d4f54e"},{"upload_doc":null,"uploadAudio":null,"medias":null,"markDefs":[],"children":[{"text":"","_key":"78eb9c0e7d38","_type":"span","marks":[]}],"_type":"block","style":"normal","_key":"64adbbd17ef3"},{"blank":true,"_type":"figure","caption":"Figure 3: Two comparative HPLC chromatograms of a primary regulatory method (top) and a secondary orthogonal method (bottom) used in the phase-appropriate method development approach advocated by H. Rasmussen and associates (3). Reprint from reference (3).","upload_doc":null,"uploadAudio":null,"medias":null,"_key":"b18fe6799158","asset":{"_ref":"image-48dd66261710c1c5b74ad58d4c0af1e1393547ae-3279x2025-jpg","_type":"reference"}},{"medias":null,"markDefs":[],"children":[{"_type":"span","marks":["strong"],"text":"A Summary of Suggested Parameter Selections for Steps 3 and 4","_key":"d3b781c623ba0"}],"_type":"block","style":"normal","_key":"fdf28509cb98","upload_doc":null,"uploadAudio":null},{"uploadAudio":null,"medias":null,"markDefs":[],"children":[{"_key":"3074f26481b70","_type":"span","marks":[],"text":"A summary of suggested parameter selections for steps 3 and 4 is listed in Table II as a reference guide for default conditions in HPLC method development for NCEs."}],"_type":"block","style":"normal","_key":"a339b73af625","upload_doc":null},{"_type":"block","style":"normal","_key":"59a42a4497f4","upload_doc":null,"uploadAudio":null,"medias":null,"markDefs":[],"children":[{"_type":"span","marks":[],"text":"","_key":"6db0608913cb"}]},{"medias":null,"blank":true,"_type":"figure","_key":"a2cdd07a1d03","asset":{"_ref":"image-67cd8dfc92c0ddd02e1ab1f569d3ee326c0daf55-642x647-jpg","_type":"reference"},"upload_doc":null,"uploadAudio":null},{"upload_doc":null,"uploadAudio":null,"medias":null,"_key":"7a806a44f00b","markDefs":[],"children":[{"_key":"7dddd5cd199f0","_type":"span","marks":[],"text":"During the life cycle of any DS or DP, the analytical methods may need to be redeveloped. A new synthetic route or process chemistry changes during scale-up may cause new impurities to be present in the final DS. Also, degradation products found in samples from stability studies may require an improved resolution for quantitation."}],"_type":"block","style":"normal"},{"medias":null,"children":[{"_key":"4959c5bde5480","_type":"span","marks":["strong"],"text":"Method Development Approaches and Automation Tools"}],"_type":"block","style":"normal","_key":"cb6c501691ff","markDefs":[],"upload_doc":null,"uploadAudio":null},{"markDefs":[],"children":[{"_key":"9b96b5f1af7d0","_type":"span","marks":[],"text":"In this section, we describe modern approaches in method development and common automated tools for expediting the process. The reader is referred to textbooks, articles, and manufacturers’ websites for updates and more complete descriptions (18–29). Prior to discussing the modern development approaches, let us discuss briefly sample diluent selection for the NCE and sample preparation for DS and DP."}],"_type":"block","style":"normal","_key":"47347df4c917","upload_doc":null,"uploadAudio":null,"medias":null},{"style":"normal","_key":"3806d74bf117","markDefs":[],"children":[{"_type":"span","marks":["strong"],"text":"Selection of Sample Diluent and Sample Preparation Procedure","_key":"bfec7fa759b30"}],"_type":"block","upload_doc":null,"uploadAudio":null,"medias":null},{"uploadAudio":null,"medias":null,"children":[{"marks":[],"text":"Knowledge about the solubility properties of the API is necessary to choose the most appropriate sample diluent. The most natural choice is to use the initial gradient concentration of the mobile phase. Although this approach may work for hydrophilic or water-soluble compounds, many hydrophobic compounds may not be fully dissolved in these mostly aqueous diluents. Increasing the organic phase concentration may result in full dissolution. However, a higher concentration of organic solvent in the sample diluents may cause chromatographic peak anomaly issues, such as peak splitting upon the injection of large sample volumes (2). Another approach may be the use of a stronger solubilizing agent (such as DMSO), in small concentrations to solubilize the compound and then dilute with the starting concentration of the mobile phase. Often, vigorous shaking manually or with a shaker, or sonication, may be required to expedite the solubilization process. Filtration of a drug substance sample is not recommended since the material must be completely dissolved in a solution for accurate quantitation.","_key":"a6cc69bc05d30","_type":"span"}],"_type":"block","style":"normal","_key":"2c395deee7da","markDefs":[],"upload_doc":null},{"uploadAudio":null,"medias":null,"children":[{"_type":"span","marks":[],"text":"Drug products, such as tablets, also have the added complications of the need to break down the formulation matrix to permit efficient and complete extraction and solubilization of the active ingredients. The separation can be especially problematic upon stability storage due to the aging of the dosage form. Multi-step dilution schemes using shakers or sonication in an appropriate extraction medium followed by filtration (such as 13–25 mm, i.d., 0.2–0.45-µm disposable membrane syringe filters) or centrifugation is generally required to obtain the final sample DP extract for analysis. For sustained-release drug product formulations, a 2-step extraction process is often needed, using an organic solvent to dissolve the polymer-based matrix in the first step. Grinding or rough-crushing the formulation may also be needed to expedite the extraction process. More detailed procedures are available in these references (2,3).","_key":"a765e30cfccf0"}],"_type":"block","style":"normal","_key":"a07024b3b99b","markDefs":[],"upload_doc":null},{"_type":"block","style":"normal","upload_doc":null,"uploadAudio":null,"medias":null,"_key":"93a761ba1a79","markDefs":[],"children":[{"_type":"span","marks":["strong"],"text":"Modern Method Development Approaches and Trends","_key":"aa1f171baf580"}]},{"_key":"5a03af0cb6cc","markDefs":[],"upload_doc":null,"uploadAudio":null,"medias":null,"children":[{"_type":"span","marks":["strong"],"text":"UHPLC","_key":"e40a50e7fbb70"}],"_type":"block","style":"normal"},{"markDefs":[],"children":[{"_type":"span","marks":[],"text":"UHPLC is a modern low-dispersion system platform with higher-pressure ratings (15,000–22,500 psi), and is the most significant innovation in HPLC in recent years (18–23). The benefits of UHPLC, when coupled with small-particle columns (sub-2 and sub-3-μm), are faster analysis, enhanced sensitivity, and higher peak capacities for sample analysis (13, 22). The lower system dwell volumes and faster column equilibration times for the smaller UHPLC columns provide another significant benefit for the method development process (12,22). In method optimization, the mobile phase and operating conditions are varied in numerous trial experiments and iterations to optimize the chromatographic behavior of all key analytes to arrive at the optimal separation. The judicious application of UHPLC can reduce method development times by a factor of 3 to 5 in comparison with those obtained with conventional HPLC systems and columns. In addition, UHPLC significantly reduces the amount of solvents used and solvent waste (22).","_key":"45056975d2a60"}],"_type":"block","style":"normal","_key":"b73aad6cb48d","upload_doc":null,"uploadAudio":null,"medias":null},{"upload_doc":null,"uploadAudio":null,"medias":null,"_key":"d1a2e3d5eb4b","markDefs":[],"children":[{"_type":"span","marks":[],"text":"A potential issue for using UHPLC in method development is the necessity to “back-translate” (also often called “back-transfer” in the literature) or convert the UHPLC methods back to HPLC conditions because many QC laboratories may not be equipped with UHPLC (2,18,23). Today, 16 years after the commercialization of the UHPLC system in 2004 (18), the need for changing the method from UHPLC back to HPLC is lessened by the wider availability of these UHPLC systems (\u003e15,000 psi), and others with intermediary pressures (for example, 9,000–2,000 psi) (19,20).","_key":"2cea1b8189f10"}],"_type":"block","style":"normal"},{"_type":"block","style":"normal","_key":"c0de4f24cc4f","markDefs":[],"children":[{"_type":"span","marks":[],"text":"","_key":"15fb8f29e3d40"}],"upload_doc":null,"uploadAudio":null,"medias":null},{"style":"normal","_key":"5b25c87bb9ce","markDefs":[],"children":[{"_type":"span","marks":["strong"],"text":"MS","_key":"a7f7fee85bf00"}],"upload_doc":null,"uploadAudio":null,"medias":null,"_type":"block"},{"markDefs":[],"upload_doc":null,"uploadAudio":null,"medias":null,"children":[{"_type":"span","marks":[],"text":"While most stability-indicating analytical procedures developed for NCEs are HPLC-UV methods, many are also beneficially designed to be MS-compatible using volatile reagents in the mobile phases to allow peak verification, tracking, and identification (2,3). The inclusion of an information-rich MS in the HPLC-UV method development system, in our view, is mandatory for a science-based and efficient method development process, and particularly useful for developing methods of complex NCEs. The MS detector is immensely helpful in the case that the impurities must be identified or qualified.","_key":"35772ccc43e50"}],"_type":"block","style":"normal","_key":"54a36b02abcd"},{"_type":"block","style":"normal","_key":"47b6447d1c91","markDefs":[],"upload_doc":null,"uploadAudio":null,"medias":null,"children":[{"_key":"651bf146de920","_type":"span","marks":[],"text":"The advent of low-cost, easy-to-use single-quadrupole MS (SQMS) makes this adoption much easier for any analytical chemist without specialized MS training (2,19). The only downside is the loss in sensitivity and linear performance for detection wavelength \u003c230 nm due tothe end absorbance of the volatile mobile phase additives (such as formic acid)."}]},{"markDefs":[],"children":[{"_type":"span","marks":[],"text":"","_key":"b6daccb2afaa0"}],"_type":"block","style":"normal","_key":"341d43006527","upload_doc":null,"uploadAudio":null,"medias":null},{"uploadAudio":null,"medias":null,"markDefs":[],"children":[{"marks":["strong"],"text":"Phase-Appropriate Method Development and Validation","_key":"dd7b11f219510","_type":"span"}],"_type":"block","style":"normal","_key":"575d0227dfb0","upload_doc":null},{"medias":null,"style":"normal","_key":"fed8dd47838e","markDefs":[],"children":[{"_type":"span","marks":[],"text":"The concept of “phase-appropriate method development and validation,”’ advocated by H. Rasmussen and associates and others in the early 2000s, recognizes that it is unrealistic to expect the original stability-indicating method for an NCE to remain unchanged during the life cycle of a new drug candidate to commercialization (3,17). It is, therefore, more realistic to have a phase-appropriate or tiered approach, in which the initial method is continuously improved as the formulation is being developed. Complete validation studies are conducted as the project is advancing to late-phase development when the synthetic chemistry process and drug product formulation are finalized.","_key":"49f8e0b2a3720"}],"_type":"block","upload_doc":null,"uploadAudio":null},{"medias":null,"markDefs":[],"children":[{"_type":"span","marks":[],"text":"The approach recommends the development of a secondary orthogonal method early for several advantages (17). While the word ","_key":"bc9991e8eb540"},{"_type":"span","marks":["em"],"text":"orthogonal separation","_key":"bc9991e8eb541"},{"_type":"span","marks":[],"text":"generally means using different retention mechanisms (for example, RPLC based on hydrophobic interaction vs. capillary electrophoresis based on the ionic mobility of the analytes), in reality, most orthogonal methods employ two columns with different selectivity (C18 vs. polar-embedded) or the same column using different organic modifiers (acetonitrile vs. methanol). The secondary orthogonal method ensures that there is no hidden impurities underneath the API peak. It can be used to analyze pivotal clinical lots for supporting data. A minimum method validation can be done to expedite the testing. In addition, the orthogonal method can be used when the primary method is found to be inadequate (such as the inability to resolve a new impurity). This approach can reduce the risk of a potential method deficiency situation, which can have a severe impact on the drug development timeline. Case studies to illustrate this approach are shown in Figures 3 and 5.","_key":"bc9991e8eb542"}],"_type":"block","style":"normal","_key":"1e56756638b5","upload_doc":null,"uploadAudio":null},{"_type":"block","upload_doc":null,"uploadAudio":null,"medias":null,"style":"normal","_key":"c2683ea8a769","markDefs":[],"children":[{"marks":["strong"],"text":"Applications of Quality by Design (QbD) and Design of Experiments (DoE) in Method Development","_key":"7d013a1369650","_type":"span"}]},{"uploadAudio":null,"medias":null,"children":[{"_type":"span","marks":[],"text":"Regulatory authorities have endorsed a science- and risk-based strategy in new drug development, using a systematic Quality by Design (QbD) approach in process development and control of critical raw materials (24). The QbD concept can also be used in method development to establish the capabilities of the method. While a traditional “one-factor-at-a-time”approach is widely practiced in method development, many laboratories have started to use a Design of Experiments (DoE) approach for method robustness validation (3,5). Others have explored the use of automated scouting or screening systems and software platforms for the method development process (2,3,25–27).","_key":"8e047522c58c0"}],"_type":"block","style":"normal","_key":"cbf69b3fa6c8","markDefs":[],"upload_doc":null},{"markDefs":[],"upload_doc":null,"uploadAudio":null,"medias":null,"children":[{"marks":[],"text":"","_key":"d7c690597f740","_type":"span"}],"_type":"block","style":"normal","_key":"113c683dd985"},{"_key":"b3a729871430","markDefs":[],"children":[{"_type":"span","marks":["strong"],"text":"Automation and Software Platform Systems for Method Development","_key":"e246d275998b0"}],"_type":"block","upload_doc":null,"uploadAudio":null,"medias":null,"style":"normal"},{"markDefs":[],"children":[{"_type":"span","marks":[],"text":"Although most HPLC systems can be post-fitted with selection valves to automate the column/mobile phase screening studies (2,3,12), many manufacturers now offer preconfigured method scouting and screening systems, often with some simple optimization algorithms. They can also work with more elaborate software platforms to facilitate the method development process (2).","_key":"433ab6ea3b6e0"}],"_type":"block","upload_doc":null,"uploadAudio":null,"medias":null,"style":"normal","_key":"2eb3c1058e3a"},{"medias":null,"markDefs":[],"children":[{"_type":"span","marks":[],"text":"Table III lists automated method scouting or screening systems and software platforms for HPLC method development. Many software platforms are available for off-line predictive modeling with inputs from limited experiments (such as DryLab) (2,4,25). Other platforms support direct instrument control and on-line optimization (such as ChromSword Auto and ACD Labs/AutoChrom) and statistical analysis of experimental results (such as Fusion QbD) (2,26–27). The reader is referred to published journal articles and the manufacturers’ websites for further details (25–27).","_key":"2b47da05ad900"}],"_type":"block","style":"normal","_key":"16e0029f93c9","upload_doc":null,"uploadAudio":null},{"_key":"5aaaefc58a77","upload_doc":null,"uploadAudio":null,"medias":null,"markDefs":[],"children":[{"_type":"span","marks":[],"text":"","_key":"d23b8aa8a946"}],"_type":"block","style":"normal"},{"blank":true,"_type":"figure","upload_doc":null,"uploadAudio":null,"medias":null,"_key":"de508fccae0c","asset":{"_ref":"image-4da001b347a31704924056e8c4298b16c1a3babf-578x733-jpg","_type":"reference"}},{"children":[{"_type":"span","marks":["strong"],"text":"A Dilemma in Early-Phase Method Development","_key":"3041a71536090"}],"_type":"block","upload_doc":null,"uploadAudio":null,"medias":null,"style":"normal","_key":"63a3c0461133","markDefs":[]},{"children":[{"_type":"span","marks":[],"text":"The use of automated and software systems can expedite the method development process, particularly in laboratories specializing in late-phase product development situations where critical process impurities and degradation products are identified and available as reference materials. This ideal test mix containing all the critical impurities is rarely available during initial method development for an NCE, making it impossible to have a systematic application of automated workflows in early development.","_key":"84721ecc69c20"}],"_type":"block","style":"normal","_key":"12ada022e14a","upload_doc":null,"uploadAudio":null,"medias":null,"markDefs":[]},{"_key":"3b505645b0e1","upload_doc":null,"uploadAudio":null,"medias":null,"markDefs":[],"children":[{"marks":[],"text":"Nevertheless, the analytical chemist still needs to have a reasonable first HPLC method to initiate sample evaluation from forced degradation studies. The most realistic scenario is to have proactive communication with the process chemist and to obtain the mother liquors of the final crystallization of the API. As a minimum, a mixture of precursors, starting materials, intermediates from previous synthetic steps, plus any additional reference materials available such as stereoisomers, can be assembled for use as method development samples (3,17).","_key":"f8e1765c4f2d0","_type":"span"}],"_type":"block","style":"normal"},{"upload_doc":null,"uploadAudio":null,"medias":null,"_key":"a1bf43f34bd7","markDefs":[],"children":[{"_type":"span","marks":["strong"],"text":"Easier Approaches to MethodDevelopment for Pharmaceutical Analysis","_key":"79ba3a7bb0200"}],"_type":"block","style":"normal"},{"markDefs":[],"upload_doc":null,"uploadAudio":null,"medias":null,"children":[{"_type":"span","marks":[],"text":"The traditional five-step approach with judicious choice of column, detector, and mobile-phase conditions works well for systematic method development for pharmaceutical analysis when implemented by experienced scientists. However, it would be desirable to have easier approaches to develop effective methods by analysts with diverse experience levels. Here we will describe two such approaches.","_key":"0050b8fb18380"}],"_type":"block","style":"normal","_key":"34dd3dcf6596"},{"style":"normal","_key":"d703a93cc491","markDefs":[],"children":[{"_type":"span","marks":[],"text":"","_key":"b2489810c5cf0"}],"upload_doc":null,"uploadAudio":null,"medias":null,"_type":"block"},{"medias":null,"_type":"block","style":"normal","_key":"a12f1e967b13","markDefs":[],"children":[{"text":"A Three-Pronged Template Approach","_key":"abdf983740f80","_type":"span","marks":["strong"]}],"upload_doc":null,"uploadAudio":null},{"medias":null,"children":[{"_type":"span","marks":[],"text":"A three-pronged template approach was proposed in 2013 to facilitate the rapid development of early-phase RPLC methods by recognizing the attributes of the three types of HPLC methods commonly used in the pharmaceutical analysis (10). These method templates, with their unique sets of characteristics and capabilities, allow a quicker method development process for scientists by recognizing the attributes and the expected final method conditions (column, operating conditions). These method templates are described below.","_key":"4abbd66594170"}],"_type":"block","style":"normal","_key":"beaa47ab3eb1","markDefs":[],"upload_doc":null,"uploadAudio":null},{"_type":"block","style":"normal","_key":"21be85ca1090","upload_doc":null,"uploadAudio":null,"medias":null,"markDefs":[],"children":[{"_type":"span","marks":["em"],"text":"Template 1. Fast (sub-2-min) LC isocratic methods","_key":"0bd4efdbc2000"},{"_type":"span","marks":[],"text":" for rough assays (potency of DS or strength of DP) used in content uniformity and dissolution (performance) testing of drug products (2). These are non-stability-indicating procedures for the determination of the main component (assay) only. They can be developed and qualified quickly. Note that this method type is not adequate to be used for actual potency assay of a DS or purity factor of a DS on a certificate of analysis (CoA), which must be derived from a validated stability-indicating method or method template #3.","_key":"0bd4efdbc2001"}]},{"children":[{"_type":"span","marks":[],"text":"","_key":"c04c8575b68f0"}],"_type":"block","style":"normal","_key":"55c566fccfc0","upload_doc":null,"uploadAudio":null,"medias":null,"markDefs":[]},{"_type":"block","style":"normal","_key":"92d9c0ff255d","markDefs":[],"upload_doc":null,"uploadAudio":null,"medias":null,"children":[{"_type":"span","marks":["em"],"text":"Template 2. Generic broad-gradient RPLC methods","_key":"df99d04c01d60"},{"marks":[],"text":" can be used for high-throughput screening (1–2 min) (5,28) or in-process control testing (4–10 min) (2,5). Still, the broad gradient RPLC methods can also be re-purposed for purity assays of simpler samples such as raw materials, starting materials, reagents, and cleaning verification (30) samples. The generic methods can be easily modified for stability-indicating assays of simpler drug molecules by extending the gradient times (","_key":"df99d04c01d61","_type":"span"},{"_type":"span","marks":["em"],"text":"t","_key":"df99d04c01d62"},{"_type":"span","marks":[],"text":"G) or using a more complex gradient profile. An organization can adopt a few generic broad-gradient methods for applications across different early development projects to reduce to burden for method development. This practice can save considerable analytical resources, reduce the method development, validation, and transfer time, and the stockpile of different HPLC columns by individual scientists within an organization (29).","_key":"df99d04c01d63"}]},{"uploadAudio":null,"medias":null,"style":"normal","_key":"e4d695caa4c8","markDefs":[],"children":[{"marks":[],"text":"","_key":"2a1a0d3d5b130","_type":"span"}],"_type":"block","upload_doc":null},{"medias":null,"markDefs":[],"children":[{"text":"Template 3. Multi-segment gradient methods. ","_key":"5aa037cd3d8d0","_type":"span","marks":["em"]},{"_type":"span","marks":[],"text":"A brief survey of literature conducted in 2013 indicated a predominance of multi-segment gradient methods for ICH-compliant stability-indicating analytical procedures for complex NCEs (2,10). The rationales for this unique gradient pattern (see Figure 4) are likely to be as follows:","_key":"5aa037cd3d8d1"}],"_type":"block","style":"normal","_key":"244895305a56","upload_doc":null,"uploadAudio":null},{"_type":"block","style":"normal","_key":"c0c2920bd2c2","markDefs":[],"upload_doc":null,"uploadAudio":null,"medias":null,"children":[{"marks":[],"text":"","_key":"eacd259b763d0","_type":"span"}]},{"upload_doc":null,"uploadAudio":null,"medias":null,"blank":true,"_type":"figure","caption":"Figure 4: An example of a gradient profile of the “multi-segment gradient method template #3” using a shallow middle segment (15–40% B in 25 min) with the main component eluted toward the end of the gradient segment. This segment is preceded by an early segment (5–15% B in 5 min) and followed by a steep segment (40–90% B in 3 min) with a 2-min purging step at 90% B. Reprinted from reference (10).","_key":"95846eda3b00","asset":{"_ref":"image-d54f052ffc4258219574260f8f9b32fc38cb0b6d-3157x2143-jpg","_type":"reference"}},{"markDefs":[],"children":[{"text":"Isomers, impurities, and degradants of the API usually have similar structures and hydrophobicity to those of the parent molecule and thus may be eluted close to the API under RPLC.","_key":"5c08a41292ff0","_type":"span","marks":[]}],"_type":"block","style":"normal","_key":"0636f6217231","upload_doc":null,"uploadAudio":null,"medias":null},{"style":"normal","_key":"e7e474e64a71","upload_doc":null,"uploadAudio":null,"medias":null,"markDefs":[],"children":[{"_key":"51f57b06e1010","_type":"span","marks":[],"text":"A shallow gradient with the API eluted toward the end of the gradient segment would maximize the resolution around the API peak. The hydrophobicity of the API defines the final %MPB of this segment."}],"_type":"block"},{"children":[{"_key":"748324844d940","_type":"span","marks":[],"text":"A steep gradient segment, followed by a purging step, is used to elute highly-retained components (dimers). An initial low-strength gradient segment (starting at 2–5% MPB) may be required to retain polar impurities (such as hydrolytic degradants)."}],"_type":"block","style":"normal","_key":"515aadd7d1e9","upload_doc":null,"uploadAudio":null,"medias":null,"markDefs":[]},{"medias":null,"_key":"20fa56f44da2","markDefs":[],"children":[{"marks":[],"text":"","_key":"3285e6c632cc0","_type":"span"}],"_type":"block","style":"normal","upload_doc":null,"uploadAudio":null},{"_type":"block","style":"normal","_key":"786ef9f7ed97","upload_doc":null,"uploadAudio":null,"medias":null,"markDefs":[],"children":[{"_type":"span","marks":[],"text":"Traditionally, a single, broad, linear gradient is used during initial method development and column screening. This fast gradient approach is acceptable for initial phase screening but is unlikely to provide sufficient resolution around the API to resolve closely eluted impurities. The understanding of the rationales for the multi-segment gradient program offers helpful insights into the fine-tuning method development steps used in method optimization (step 4). Note that linear gradient segments are invariably used, and isocratic steps should be avoided to reduce method transfer issues between different HPLC or UHPLC systems.","_key":"53fde6d6fa850"}]},{"uploadAudio":null,"medias":null,"style":"normal","_key":"e1bc5947ff1a","markDefs":[],"children":[{"marks":["strong"],"text":"Case Studies to Illustrate the Use of Multi-Segment Gradient Approach for Complex DS and DP Methods","_key":"ef358c2477600","_type":"span"}],"_type":"block","upload_doc":null},{"upload_doc":null,"uploadAudio":null,"medias":null,"_type":"block","style":"normal","_key":"287338973991","markDefs":[],"children":[{"_type":"span","marks":[],"text":"Two case studies are included here to illustrate the application of this multi-segment gradient approach in the method development of complex pharmaceuticals (13). The third case study is an early UHPLC method development example of an NCE DS method and the “back-transfer” to HPLC conditions (9).","_key":"70d0ef74cdea0"}]},{"medias":null,"style":"normal","_key":"1808f64f78d1","markDefs":[],"children":[{"_type":"span","marks":[],"text":"","_key":"6e2dfac725bd0"}],"_type":"block","upload_doc":null,"uploadAudio":null},{"uploadAudio":null,"medias":null,"_type":"block","style":"normal","_key":"388ea4010d7b","markDefs":[],"children":[{"_type":"span","marks":["strong"],"text":"A Complex NCE with Three Chiral Centers","_key":"eebef3791eb90"}],"upload_doc":null},{"_key":"61aaa4a8ebed","markDefs":[],"children":[{"_type":"span","marks":[],"text":"Figure 5a shows a chromatogram in a method development case study for a complex molecule with three chiral centers. Here, the resolution of the four pairs of diastereomers becomes the crucial criterion for quality assessment (13). The middle gradient segment employed is a shallow gradient (15–40%B in 25 min) used to separate the API (with an absolute configuration of SRR) from its diastereomers (SRS, RRR, and RRS) and other impurities (M416, M456, and M399, designated as their parent (M+H)1+ ions). A low-strength initial gradient allows for the retention of a hydrolytic degradant (M235), while the final segment depicts a steep gradient that elutes any dimers or other late-eluting species. Note that this 42-min HPLC method has been converted into a 17-min UHPLC method using a 100-mm column packed with 2-µm particles with equal resolution performance (13).","_key":"70874e24d7680"}],"upload_doc":null,"uploadAudio":null,"medias":null,"_type":"block","style":"normal"},{"medias":null,"markDefs":[],"children":[{"text":"","_key":"be77551be28d","_type":"span","marks":[]}],"_type":"block","style":"normal","_key":"a32e24c7a072","upload_doc":null,"uploadAudio":null},{"_key":"bad0029a9e77","upload_doc":null,"uploadAudio":null,"medias":null,"asset":{"_type":"reference","_ref":"image-43c79f7358c7fa14971db2af655ae2b8c6622ad1-3138x2355-jpg"},"blank":true,"_type":"figure","caption":"Figure 5: Chromatograms illustrating the applications of template #3 in the separation of the four diastereomers in a multi-chiral NCEs with three chiral centers described in reference 13. Column and full operating conditions are shown in the inset. (a) the 42-min primary regulatory HPLC method using a C18 column with acetonitrile; (b) a secondary orthogonal method using a phenyl column and methanol."},{"_key":"6291b19f21b4","upload_doc":null,"uploadAudio":null,"medias":null,"markDefs":[],"children":[{"text":"Figure 5b shows a chromatogram of the secondary orthogonal method developed at the same time, which yields a better resolution of the diastereomers using a phenyl column and methanol. Nevertheless, the HPLC conditions used in Figure 5a with an analysis time of 42 min was employed as the primary regulatory method due to its higher overall resolution and peak capacity. The case study also illustrates the implementation of a proactive method development approach using a secondary orthogonal method to ensure there are no impurities hidden underneath the API peak (2,3).","_key":"2ce0e24fae9b0","_type":"span","marks":[]}],"_type":"block","style":"normal"},{"medias":null,"markDefs":[],"children":[{"_type":"span","marks":[],"text":"","_key":"abefe84b7ec20"}],"_type":"block","style":"normal","_key":"5f62ee700df8","upload_doc":null,"uploadAudio":null},{"markDefs":[],"children":[{"text":"A Method for a Complex DP with Multiple APIs","_key":"9972fedff89f0","_type":"span","marks":["strong"]}],"_type":"block","style":"normal","_key":"c96975d45a83","upload_doc":null,"uploadAudio":null,"medias":null},{"_type":"block","style":"normal","_key":"cb80b26eb141","markDefs":[],"children":[{"_type":"span","marks":[],"text":"Figure 6 shows a UHPLC-UV chromatogram of a retention marker solution consisting of 60+ components used in a stability-indicating method for a complex DP with four APIs (Strilbild tablet for HIV indication). The method uses a 5-segment linear gradient profile customized to maximize the resolution of the four APIs. The method development process utilized a software-assisted approach using the QbD principle (13,27). This procedure has been successfully validated, and a validation summary data is available from the reference paper (13).","_key":"ac7eaaefd3d70"}],"upload_doc":null,"uploadAudio":null,"medias":null},{"uploadAudio":null,"medias":null,"_key":"bf885fb9c9ab","markDefs":[],"children":[{"_key":"dc8f3fd7f37e0","_type":"span","marks":[],"text":""}],"_type":"block","style":"normal","upload_doc":null},{"asset":{"_ref":"image-d0d0b6bed0948d5667bb7434cdbac9d25cea1f42-2912x1422-jpg","_type":"reference"},"blank":true,"_type":"figure","caption":"Figure 6: Chromatogram showing a stability-indicating UHPLC method for a drug product Stribild oral tablet with four APIs (elvitegravir, cobicistat, emtricitabine, and tenofovir disoproxil fumarate). UHPLC method conditions are shown in the inset. Chromatogram reprinted from reference (13).","_key":"d117ac2984b4","upload_doc":null,"uploadAudio":null,"medias":null},{"style":"normal","_key":"18e506b75686","markDefs":[],"children":[{"_key":"c58ab0276ee50","_type":"span","marks":["strong"],"text":"An Early UHPLC Method Development Case Study of an NCE DS Procedure"}],"_type":"block","upload_doc":null,"uploadAudio":null,"medias":null},{"style":"normal","_key":"09a4f2be2468","upload_doc":null,"uploadAudio":null,"medias":null,"markDefs":[],"children":[{"_type":"span","marks":[],"text":"Figures 7a–d shows a sequence of four chromatograms obtained during an early UHPLC method development case study of an NCE DS method, which has several light degradants published in 2007 (9). Figure 7a shows the original 35-min HPLC chromatogram from a client using a phosphate buffer. This mostly isocratic method was not acceptable because a shoulder “hump” was observed on the downslope of the API peak, indicating the presence of a hidden impurity. Figure 7b shows a 5-min broad-gradient column screening study using a 50-mm C18 column showing an equivalent separation of the original HPLC chromatogram. The entire 4-column screens study took 1 h, indicating a polar-embedded phase (Acquity Shield RP18, 50 x 2.1 mm, 1.7-µm) yielded the best separation around the critical region. MPA was changed to an MS-compatible buffer of 20-mM ammonium format at pH 3.7. Figure 7c shows the final 13-min UHPLC method using an Acquity Shield RP18, 100 x 2.1 mm, 1.7-µm, which yielded an improved resolution of three impurities peaks in the critical region. Figure 7d shows the final 20-min “back-translated” HPLC method using an HPLC column (XBridge Shield RP18, 150 x 3.0 mm, 3.5-µm). This process took 2 d, using principles of “geometric-scaling” (23), assisted by a modeling software (DryLab) to ensure that all three light degradants labeled with an asterisk could be resolved. The entire method development project took about 1 week, including the “back-translation” of the UHPLC method into HPLC conditions.","_key":"776dba28d6240"}],"_type":"block"},{"upload_doc":null,"uploadAudio":null,"medias":null,"markDefs":[],"children":[{"marks":[],"text":"","_key":"71a5188f38b3","_type":"span"}],"_type":"block","style":"normal","_key":"548996810171"},{"caption":"Figure 7: A case study of the UHPLC method development of a DS method of an NCE with several light degradants. (a) The original 35-min HPLC method using a phosphate buffer at pH 3.1; (b) A 5-min broad-gradient column screening study using a short C18 column; (c) The final 13-min UHPLC method (Acquity Shield RP18, 100 x 2.1 mm, 1.7-μm) yields three impurities peaks in the critical region; (d) The final 20-min “back-translated” HPLC method using an HPLC column (XBridge Shield RP18, 150 x 3.0 mm, 3.5-μm) showing the resolution of three light degradants. ","_key":"56fa21720d89","asset":{"_ref":"image-b42b9e0bf3df68b8160a2c428f5e0cd21c8de343-3270x2186-jpg","_type":"reference"},"upload_doc":null,"uploadAudio":null,"medias":null,"blank":true,"_type":"figure"},{"medias":null,"markDefs":[],"children":[{"_key":"ce402e47dcf10","_type":"span","marks":["strong"],"text":"A Modernized Universal Generic Method for Multiple NCEs"}],"_type":"block","style":"normal","_key":"5b1fc775d638","upload_doc":null,"uploadAudio":null},{"children":[{"_type":"span","marks":[],"text":"Wouldn’t it be nice if we could have a single universal generic gradient method that works for multiple NCEs and most pharmaceutical analyses? The concept appeared to work well for cleaning verification when a 10-min HPLC-UV generic method was found suitable for multiple NCEs in a small-molecule portfolio of an organization in 2012 (30). In 2014, the idea was further extended by applying the latest column technologies (short columns packed with sub-3-µm superficially porous particles (SPP) with improved bonded chemistry) to allow the development of a modernized version of a 2-min generic gradient method operating at optimum conditions with simple mobile phases (11).","_key":"a2d5e1a165b00"}],"_type":"block","upload_doc":null,"uploadAudio":null,"medias":null,"style":"normal","_key":"a7281d8a8f93","markDefs":[]},{"_key":"da3b000f9b2a","markDefs":[],"children":[{"_type":"span","marks":[],"text":"Figure 8a shows the performance of this modernized generic gradient HPLC-UV–MS method in the separation of a 12-component test mix (11). The method has a peak capacity (Pc) of 100, and resolves ten peaks out a mixture of 12 NCEs with good peak shapes and sensitivity with simple mobile phases on both HPLC and UHPLC systems (3700 psi). Best of all, the “standard” 2-min method can be easily adjusted to resolve all twelve NCEs with a run time of 5 min by simple adjustments of gradient conditions (Figure 8b).","_key":"72c3555642be0"}],"upload_doc":null,"uploadAudio":null,"medias":null,"_type":"block","style":"normal"},{"medias":null,"_type":"block","style":"normal","_key":"4425a2c6b529","markDefs":[],"children":[{"_key":"03bfb7e402b4","_type":"span","marks":[],"text":""}],"upload_doc":null,"uploadAudio":null},{"uploadAudio":null,"medias":null,"caption":"Figure 8: (a) The separation of a 12-NCE mixture using the proposed 2-min universal gradient reversed-phase chromatography method using a sub-3-μm superficially pourous particle column. (b) A chromatogram depicting the achievement of near-baseline resolution of all 12 NCEs in the test mixture by adjustments of gradient conditions using the same bonded phase in a 2.1 mm column format. Each peak is designated by its code name, retention time in minutes, and (M+H) +1 parent ion. Reprinted from reference 11.","_key":"e8e2cb6e6760","asset":{"_ref":"image-661ed82f6531610d6f4e745ae7746f9d7a2f711b-3119x2250-jpg","_type":"reference"},"blank":true,"_type":"figure","upload_doc":null},{"_type":"block","style":"normal","upload_doc":null,"uploadAudio":null,"medias":null,"_key":"963b098695b5","markDefs":[],"children":[{"_type":"span","marks":[],"text":"The rationales in the selection of columns, mobile phases, and operating conditions are explained in the 2016 reference (11). This reference also provides several case studies that this generic method can be applied to stability-indicating applications by quick adjustments of gradient conditions (using longer ","_key":"8c5d52dd1c080"},{"_type":"span","marks":["em"],"text":"t","_key":"8c5d52dd1c081"},{"_type":"span","marks":[],"text":"G and multi-segment gradient) to obtain reasonable initial method conditions. The next steps can be a column or mobile-phase screening and the use of a longer column to arrive at the final regulatory method conditions.","_key":"8c5d52dd1c082"}]},{"markDefs":[],"children":[{"_type":"span","marks":[],"text":"In summary, a generic gradient method using a short column operating at optimum conditions shown in Figure 8a (for example, C18, 50 mmx 3.0 mm i.d., 2.7-µm SPP, 5 - 60% acetonitrile in 2 min at 1 mL/min) is capable of delivering peak capacities (Pc) of 100-300 in 2 to 10 minutes (2,31–32). The generic method approach works well for cleaning verification of multiple NCEs and provides a useful starting point in the development of stability-indicating analytical procedures.","_key":"46c3788bad3c0"}],"_type":"block","upload_doc":null,"uploadAudio":null,"medias":null,"style":"normal","_key":"f1c91760ac6f"},{"style":"normal","_key":"9020ddda096b","markDefs":[],"children":[{"_type":"span","marks":["strong"],"text":"Method Content, Execution, and Life Cycle Management","_key":"95482ff091080"}],"upload_doc":null,"uploadAudio":null,"medias":null,"_type":"block"},{"children":[{"_type":"span","marks":[],"text":"We devote the final section to discussing the essential elements in a well-written HPLC method (33), guidance in method execution to generate more reliable stability data, and the concept of life cycle management of analytical procedures (34).","_key":"6f98b1e562e50"}],"_type":"block","style":"normal","_key":"eeec73b462ed","upload_doc":null,"uploadAudio":null,"medias":null,"markDefs":[]},{"children":[{"_type":"span","marks":["strong"],"text":"Method Content and Essential Elements in an Analytical Procedure","_key":"e9fed7129be10"}],"upload_doc":null,"uploadAudio":null,"medias":null,"_type":"block","style":"normal","_key":"05185e48d519","markDefs":[]},{"_key":"9ea7c7533776","markDefs":[],"upload_doc":null,"uploadAudio":null,"medias":null,"children":[{"_key":"80446a7bd6080","_type":"span","marks":[],"text":"A well-written analytical procedure with all essential elements is critical for its successful execution of the laboratory. Table IV lists these essential elements for late-stage methods, excerpted from a recent U.S. FDA guidance document (33)."}],"_type":"block","style":"normal"},{"children":[{"marks":[],"text":"","_key":"e81209a61855","_type":"span"}],"_type":"block","upload_doc":null,"uploadAudio":null,"medias":null,"style":"normal","_key":"7045c0651017","markDefs":[]},{"_type":"figure","upload_doc":null,"uploadAudio":null,"medias":null,"_key":"a47aecc7b196","asset":{"_ref":"image-8f3b4e814c5fd646ada6cdcc5ced46d1372cf755-647x702-jpg","_type":"reference"},"blank":true},{"uploadAudio":null,"medias":null,"children":[{"_type":"span","marks":[],"text":"In addition, it is also essential to include as many helpful details in the written method as the analyst will need to successfully execute the method. The method should include example chromatograms (both full- and expanded-scale of a blank, retention marker solution or SSTsolution, standard solution, and a typical sample solution), safety precautions, a table of RRT and RRF if available (2), and method history with reasons for revisions.","_key":"cd6677b4267f0"}],"_type":"block","style":"normal","_key":"39d7dc6c8d6f","markDefs":[],"upload_doc":null},{"_type":"block","upload_doc":null,"uploadAudio":null,"medias":null,"style":"normal","_key":"10ac0a081f9e","markDefs":[],"children":[{"_type":"span","marks":[],"text":"","_key":"20f2d41ba0740"}]},{"uploadAudio":null,"medias":null,"markDefs":[],"children":[{"_key":"91f74d4aa2f20","_type":"span","marks":["strong"],"text":"Strategies for Method Execution to Generate Reliable Stability Data"}],"_type":"block","style":"normal","_key":"57a8d9cf919b","upload_doc":null},{"upload_doc":null,"uploadAudio":null,"medias":null,"markDefs":[],"children":[{"text":"A well-developed and written analytical procedure with full validation and vigorous transfer process is the cornerstone for effective method execution. Understanding the chemistry of the NCE, the physicochemical characteristics of the molecule (such as photosensitivity, hygroscopicity, forms, reactivity, and chirality) and their effects on the stability profile of the DS and DP is crucial. The judicious use of forced degradation and accelerated stability studies, and predictive software models (7) can often reduce the need for conducting more stability studies.","_key":"72e2a1381b230","_type":"span","marks":[]}],"_type":"block","style":"normal","_key":"96943d94b84b"},{"uploadAudio":null,"medias":null,"_key":"0d8e8299b4a1","markDefs":[],"children":[{"_key":"945039fb0fd90","_type":"span","marks":[],"text":"Ideally, the CMC analytical team lead, having intimate knowledge of the drug candidate, should be responsible for the method development and conducting the initial release testing and stability study of the first clinical batches. This work allows a better understanding of the stability profile of the NCE and the nuances in method execution before outsourcing stability studies to external contract organizations. In general, the contract manufacturing organizations (CMOs) selected for the large-scale production of clinical trial materials (CTMs), tend to be preferred partners for conducting stability studies, because they have a higher stake in the success of the development project. It is customary to include shipment of the SST retention marker solutions to the transferred laboratories to lessen the occurrence of peak misidentification caused by retention time peak shifts and potential stability data issues down the line."}],"_type":"block","style":"normal","upload_doc":null},{"style":"normal","upload_doc":null,"uploadAudio":null,"medias":null,"_key":"635319f4b6e3","markDefs":[],"children":[{"_type":"span","marks":["strong"],"text":"Life Cycle Management of Analytical Procedures","_key":"b8435b263cf50"}],"_type":"block"},{"upload_doc":null,"uploadAudio":null,"medias":null,"style":"normal","_key":"93d576006075","markDefs":[],"children":[{"_type":"span","marks":[],"text":"The life cycle management approach can benefit a laboratory and the drug developer by improving the performance of methods, reducing analytical uncertainties such as out-of-specification (OOS) and out-of-trend (OOT) results, and improving the success of the method transfers.","_key":"7e6b8afc294b0"}],"_type":"block"},{"_key":"a97d0d79d1ab","markDefs":[],"children":[{"_type":"span","marks":[],"text":"Life cycle management of analytical procedures is an integrated method design, development, and performance characterization strategy based on a structured and systematic approach using concepts of QbD similar to those applied to new drug development (24,34). This approach should be phase appropriate during the early drug substance method development to the final fully validated late-stage drug product methodologies. The strategy starts with the definition of an analytical target profile (ATP)–where the requirements of the analytical procedure (what to measure, method and sample type, separation criteria and performance requirements) for assessing the critical quality attributes (CQAs) of the drug substance and the drug products are described. The three stages of the life cycle are:","_key":"3c3a64d095110"}],"_type":"block","upload_doc":null,"uploadAudio":null,"medias":null,"style":"normal"},{"_key":"f74731422ccd","upload_doc":null,"uploadAudio":null,"medias":null,"markDefs":[],"children":[{"_type":"span","marks":["strong"],"text":"Stage 1: Method Design and Development","_key":"386161e64e440"}],"_type":"block","style":"normal"},{"uploadAudio":null,"medias":null,"children":[{"_type":"span","marks":[],"text":"This stage includes an understanding of the variability of the method, risk assessments, and proposed control strategy for critical method parameters (CMPs) that may pose a risk to consistently achieving method requirements.","_key":"d87b77f0141f0"}],"_type":"block","style":"normal","_key":"065469159b2c","markDefs":[],"upload_doc":null},{"medias":null,"markDefs":[],"children":[{"_type":"span","marks":["strong"],"text":"Stage 2: Method Performance Qualification","_key":"e9bcc2a9eb990"}],"_type":"block","style":"normal","_key":"edcb88c0995e","upload_doc":null,"uploadAudio":null},{"uploadAudio":null,"medias":null,"_key":"0363fe511b65","markDefs":[],"children":[{"_type":"span","marks":[],"text":"The method, with the proposed control strategy, is qualified to ensure it meets its requirements consistently. This stage includes the method validation process and can be phase appropriate depending on the stage of development.","_key":"c20ad13048660"}],"_type":"block","style":"normal","upload_doc":null},{"children":[{"_type":"span","marks":["strong"],"text":"Stage 3: Continued Method Performance Optimization or Verification","_key":"55a5999e8d6d"}],"_type":"block","upload_doc":null,"uploadAudio":null,"medias":null,"style":"normal","_key":"74133dd4c58d","markDefs":[]},{"uploadAudio":null,"medias":null,"markDefs":[],"children":[{"marks":[],"text":"This stage includes monitoring the performance after the method is placed into routine QC use by using control samples and charts as well as evaluation and continuous improvements of the method. The results of method transfer can be part of the performance verification process.","_key":"f410a1096dc50","_type":"span"}],"_type":"block","style":"normal","_key":"cdf8aae51d86","upload_doc":null},{"style":"normal","_key":"fef967e18eaa","markDefs":[],"children":[{"_type":"span","marks":["strong"],"text":"Summary and Conclusions","_key":"b0dc40ec04da0"}],"_type":"block","upload_doc":null,"uploadAudio":null,"medias":null},{"_type":"block","style":"normal","_key":"07ab8a0a5137","markDefs":[],"upload_doc":null,"uploadAudio":null,"medias":null,"children":[{"text":"This paper provides an overview of the fundamentals and best practices in the development of stability-indicating methods for pharmaceuticals. It describes the traditional five-step method development approach, as well as modern trends, easier approaches, and software tools for expediting the process. The regulatory guidance on a well-written method, strategy for efficient method execution, and life cycle management of analytical procedures are also discussed.","_key":"39373b44aa3b0","_type":"span","marks":[]}]},{"medias":null,"_key":"e6341d3e1f15","markDefs":[],"children":[{"text":"Acknowledgments","_key":"9cfcc3134f460","_type":"span","marks":["strong"]}],"_type":"block","style":"normal","upload_doc":null,"uploadAudio":null},{"medias":null,"_type":"block","style":"normal","_key":"84339a41f268","markDefs":[],"children":[{"text":"The authors express their gratitude to the following colleagues for their time and efforts to provide timely reviews of the manuscript to improve content accuracy and clarity: Tao Jiang of Mallinckrodt; Anissa Wong and Chris Foti of Gilead Sciences; Mike Shifflet of Johnson and Johnson Consumer Health Care; He Meng of Sanofi; Adrijana Torbovska of Farmahem; Alice Krumenaker of TW Metals, LLC; Mark Shapiro of MCS Pharma Consulting; Szabolcs Fekete of U. Geneva; Deidre Cabooter of KU Leuven; Tamara Andreoli of Medinova AG, Schweiz; Michael DeHart of CMP Pharma; Marc Foster of Mythctest.","_key":"fc08ff06d4a20","_type":"span","marks":[]}],"upload_doc":null,"uploadAudio":null},{"upload_doc":null,"uploadAudio":null,"medias":null,"markDefs":[],"children":[{"_type":"span","marks":["strong"],"text":"References","_key":"3439929080110"}],"_type":"block","style":"normal","_key":"6e3143ea6ff8"},{"markDefs":[],"children":[{"text":"L.R. Snyder, J.J. Kirkland, and J.L. 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European editions typically draw a crowd of more than 1200 (peaking to close to 1500 for some editions).","_key":"96184612ddf80"}],"_type":"block"},{"_type":"block","style":"normal","_key":"24d10186b8ff","markDefs":[],"children":[{"_type":"span","marks":[],"text":"In Bruges, the programme will kick-off in the splendid Concert Hall on Sunday with a plenary presentation by Koen Sandra (RIC Group, Belgium) on the recent advancements in mRNA structural characterization and by Kerstin Thurow (CELISCA – Center for Life Science Automation, Germany) on the automation of the analytical life science laboratory.","_key":"95dfd45f86ac0"}]},{"markDefs":[],"children":[{"_type":"span","marks":[],"text":"From Monday, the conference will be continued in the adjacent, brand-new BMCC conference centre, where a timely and forward-looking scientific programme will be offered. Traditionally, the HPLC showcases the broadest possible selection of chromatography-related topics, including sample preparation, detection and data analysis, presented by the best scientists active in the field. In Bruges, considerable attention will also be paid to the related separation sciences, including preparative chromatography, supercritical fluid chromatography (SFC), gas chromatography (GC), field flow factionation, and associated particle separation techniques. A strong focus will also be put on machine learning (ML) and sustainability, with dedicated sessions and tutorials on the topic. Furthermore, the conference will have a strong focus on today’s and tomorrow’s practice in high-performance liquid chromatography (HPLC) laboratories, including all aspects of laboratory automation and data processing.","_key":"e92b5f7454fd0"}],"_type":"block","style":"normal","_key":"1b075c9f2ec3"},{"markDefs":[],"children":[{"_type":"span","marks":[],"text":"Next to the Csaba Horvath Award competition for the best early career oral presentation, early-career participants will be able to engage in dedicated poster and flash presentation competitions (with two separate awards). They will be offered a maximum number of oral presentation slots and will enjoy a broad selection of educational workshops and tutorials. Researchers nearing the end of their Ph.D. or postdoc will find the job speed date and career workshop to their liking.","_key":"881edc854d240"}],"_type":"block","style":"normal","_key":"e692288c3601"},{"_type":"block","style":"normal","_key":"093f960a0e9e","markDefs":[],"children":[{"_type":"span","marks":[],"text":"The combined exhibition, poster sessions, and catering hall will serve as the central hub of the conference, ensuring a lively and engaging atmosphere. This will undoubtedly peak during the poster and exhibitor fest we plan to organize on Monday and Tuesday afternoon. To encourage scientific discussions between delegates and vendors during these three-hour sessions, poster abstracts topics will be linked to the vendors’ offerings and an app will be used to select (and reward) the delegate having the most vendor-interactions. Under the name “Bring Your Boss To The HPLC,” a separate networking track will be offered to participating laboratory managers and decision-makers where they can share experiences and contemplate on the future of their laboratories.","_key":"7d84308bd6a10"}]},{"markDefs":[],"children":[{"_type":"span","marks":[],"text":"To encourage scientific exchange and friendship building, the scientific programme will be topped with a rich social programme, reflecting the well-known Belgian hospitality, and its abundant food and drink culture.","_key":"e7c99257fffb0"}],"_type":"block","style":"normal","_key":"41638fa75638"},{"children":[{"marks":[],"text":"Bruges is a city renowned for its well-preserved medieval architecture and many historic attractions such as the bustling Market Square, the serene Begijnhof, and picturesque canals, all within a 10 min to 15 min walk from the conference centre. The entire city is a UNESCO World Heritage site and is often referred to as the “Venice of the North.” Bruges is also famous for its broad choice of culinary delights, including exquisite Belgian chocolates, waffles, and world-renowned beers. Located in the Flanders region, Bruges is easily accessible through the well-connected international airport in Brussels (one direct train per hour). Major European cities such as Amsterdam, London, and Paris are within a range of maximally 300 km, and all easily connected by high-speed train.","_key":"4d225637dfc30","_type":"span"}],"_type":"block","style":"normal","_key":"deecb75a96e4","markDefs":[]},{"children":[{"_type":"span","marks":[],"text":"The chair team, consisting of Gert Desmet, Frederic Lynen, Sebastiaan Eeltink, Deirdre Cabooter, Ken Broeckhoven and honorary chair, Pat Sandra, look forward to welcoming you with open arms in Bruges for a memorable conference. Important deadlines to consider are ","_key":"b1d3b5db04560"},{"_type":"span","marks":["strong"],"text":"January 15 2024","_key":"1ff625984a4e"},{"_key":"939bf8a096ab","_type":"span","marks":[],"text":" for oral abstract submissions and "},{"_type":"span","marks":["strong"],"text":"April 24 2024","_key":"b608474352a8"},{"_type":"span","marks":[],"text":" for early-bird registration fees.","_key":"52e8ce6e95c1"}],"_type":"block","style":"normal","_key":"eb7a88e9b8dc","markDefs":[]},{"children":[{"_type":"span","marks":[],"text":"Learn more at ","_key":"2ddde310fb75"},{"_type":"span","marks":["ca284085fbb3"],"text":"hplc2025-briges.org","_key":"58332f6e4f7b"},{"_type":"span","marks":[],"text":". Direct correspondence to: ","_key":"5c1c2230fc70"},{"_type":"span","marks":["59c319fbf18c"],"text":"contact@hplc2025-bruges.org","_key":"fa4c8b9b34e6"}],"_type":"block","style":"normal","_key":"7d13645e30da","markDefs":[{"_type":"emailAddress","href":"contact@hplc2025-bruges.org","_key":"59c319fbf18c"},{"href":"https://hplc2025-briges.org","_key":"ca284085fbb3","nofollow":true,"blank":true,"_type":"link"}]}],"targeting":{"content_placement":["latest-conference","topic/mass-spectrometry","topic/liquid-chromatography-lchplc","topic/hplc"],"document_url":["in-bruges-hplc-2025"],"document_group":{"_type":"documentGroup","_updatedAt":"2023-01-10T14:53:35Z","pixelTrackingCode":null,"identifier":{"current":"conferences/hplc","_type":"slug"},"parent":{"identifier":{"current":"conferences","_type":"slug"},"_createdAt":"2022-12-14T16:13:41Z","_rev":"5JXChRWe9ltMSvmeBmvM3H","_type":"documentGroup","name":"Conferences","parent":null,"_id":"a994e365-e0ae-4bad-9f4c-8c3785307200","_updatedAt":"2022-12-14T16:31:58Z"},"name":"HPLC","_id":"e9ab0984-bee2-422d-b186-1246131567cc","_createdAt":"2023-01-10T14:53:23Z","_rev":"ruT5KGVoJGybWtnNFDyep0"},"rootDocumentGroup":["conferences"],"issue_url":"","publication_url":""},"relatedArticles":[{"title":"Best of the Week: EAS 2024 Awardees, Oligonucleotides in Drug Development, and More","url":{"current":"best-of-the-week-eas-2024-awardees-oligonucleotides-in-drug-development-and-more","_type":"slug"},"thumbnail":{"_type":"mainImage","asset":{"_ref":"image-188f060f8e226e80446f85f1fdd3c3b187d38833-845x266-jpg","_type":"reference"}},"published":"2024-11-22T14:52:33.534Z"},{"title":"2024 EAS Awardees Showcase Innovative Research in Analytical Science","url":{"current":"2024-eas-awardees-showcase-innovative-research-in-analytical-science","_type":"slug"},"thumbnail":{"_type":"mainImage","asset":{"_ref":"image-c8147ea69c3ab92f46645b82af811e4e20e171f8-4032x3024-jpg","_type":"reference"}},"published":"2024-11-20T19:42:54.542Z"},{"title":"Rising Stars of Separation Science 2024","url":{"current":"rising-stars-of-separation-science-2024","_type":"slug"},"thumbnail":{"_type":"mainImage","alt":"Rising Stars of Separation Science 2024 ","asset":{"_ref":"image-8d44c273c472b751c853ea437f1263ad2280aadf-552x368-jpg","_type":"reference"}},"published":"2024-11-20T05:06:00.000Z"},{"title":"Critical Role of Oligonucleotides in Drug Development Highlighted at EAS Session","url":{"current":"critical-role-of-oligonucleotides-in-drug-development-highlighted-at-eas-session","_type":"slug"},"thumbnail":{"_type":"mainImage","asset":{"_ref":"image-e7f5964eded73ee8ef4f46f3a6a19ef5a7218e41-4032x3024-jpg","_type":"reference"}},"published":"2024-11-19T13:22:37.741Z"},{"title":"RAFA 2024 Highlights: Contemporary Food Contamination Analysis Using Chromatography","url":{"current":"rafa-2024-highlights-contemporary-food-contamination-analysis-using-chromatography","_type":"slug"},"thumbnail":{"_type":"mainImage","asset":{"_ref":"image-6443e6d1598a61e2a595434c48ba745084203f00-1248x1540-png","_type":"reference"}},"published":"2024-11-18T13:00:00.000Z"},{"title":"Best of the Week: Emerging Chromatography Leader, Bladder Cancer Research, and HPLC 2025","url":{"current":"best-of-the-week-emerging-chromatography-leader-bladder-cancer-research-and-hplc-2025","_type":"slug"},"thumbnail":{"_type":"mainImage","asset":{"_ref":"image-188f060f8e226e80446f85f1fdd3c3b187d38833-845x266-jpg","_type":"reference"}},"published":"2024-11-15T16:25:25.054Z"}]},{"ExcludeFromHomePage":false,"_type":"article","issueGroup":{"_ref":"315e4e0f-39b3-4f9c-b4f2-49422d9170a4","_type":"reference"},"_id":"a1f58846-799d-460a-83a9-d374a707ef64","_updatedAt":"2024-11-11T13:11:52Z","authors":[{"displayName":"Juby Mathew","url":"juby-mathew"},{"displayName":"Leslie P. Silva","url":"leslie-p-silva"},{"displayName":"Chad Bastian","url":"chad-bastian"},{"displayName":"Christopher Williams","url":"christopher-williams"},{"displayName":"Alyssa McBurney","url":"alyssa-mcburney"},{"displayName":"Mark J. Perkins","url":"mark-j-perkins"},{"displayName":"Vaughan S. Langford","url":"vaughan-s-langford"}],"factCheckAuthorMapping":null,"body":[{"style":"normal","_key":"6085e5482cef","markDefs":[],"children":[{"marks":["strong"],"text":"Pharmaceutical excipients, such as polyethylene glycol-based polymers, must be tested for the presence of ethylene oxide (EtO) and 1,4-dioxane as part of a safety assessment, according to USP Chapter \u003c228\u003e. Selected ion flow tube mass spectrometry (SIFT-MS) offers advantages over conventional GC methods and accelerates quantitative and selective analysis of EtO and 1,4-dioxane through elimination of a lengthy matrix-match preparation and shorter run times providing 9- to 14-fold higher daily throughput than gas chromatography (GC). These efficiencies are gained while maintaining high analytical sensitivity, using 10-fold less sample per analysis.","_key":"79477a0671c2","_type":"span"}],"_type":"block"},{"_type":"block","style":"normal","_key":"6ade6ae562cb","markDefs":[],"children":[{"_type":"span","marks":[],"text":"Ethylene oxide is used as a raw material in the chemical industry for the manufacture of polyethylene glycols (PEGs) and polysorbate (trade name Tween), compounds used as solubilizers or stabilizers in pharmaceutical formulations. Ethylene oxide is an environmental pollutant (1) and mutagenic to humans (2). The ethylene oxide ring can be hydrolyzed to form diethylene glycol, which is then dehydrated to generate 1,4-dioxane, a carcinogen linked to organ toxicity. As a result of the myriad of problems attributed to ethylene oxide and 1,4-dioxane, pharmaceutical quality requirements include limits on residual ethylene oxide and dioxane.","_key":"3205749672f30"}]},{"_type":"block","style":"normal","_key":"1267d89df93d","markDefs":[],"children":[{"_type":"span","marks":[],"text":"Conventional ethylene oxide and 1,4-dioxane analysis in polyethylene oxide products use gas chromatography (GC) with flame ionization detection (GC–FID) (3). This approach is slow from the perspective of sample preparation (4) and throughput. For testing where standards are prepared in PEG, for example, residual volatiles must be removed by placing the PEG under vacuum at 60 °C for 6 h. Furthermore, the GC–FID run time is 38 min for each sample.","_key":"63eb2fd04b640"}]},{"children":[{"_type":"span","marks":[],"text":"In the current study, a simplified alternative analytical approach is postulated. By leveraging the greater sensitivity of selected ion flow tube mass spectrometry (SIFT-MS) with headspace analysis, a much smaller quantity of PEG sample is used compared to headspace GC–FID. Sample preparation time is significantly reduced because this approach eliminates the need for matrix matching and therefore excludes the need for the 6-h PEG purification step (Figure 1). Additionally, direct sample analysis using headspace-SIFT-MS provides a nine-fold higher sample throughput than GC–FID and therefore a much faster time to first test result when calibrations, blanks, and a system suitability tests (SSTs) are considered (85 min. compared to 6–12 h) (5). The results obtained confirm the ability of headspace-SIFT-MS to rapidly quantify ethylene oxide in commercial samples of polymeric excipients, including in the presence of acetaldehyde.","_key":"f176458510c10"}],"_type":"block","style":"normal","_key":"ee798f427d56","markDefs":[]},{"imgcaption":[{"_key":"aaa77466c240","markDefs":[],"children":[{"_type":"span","marks":[],"text":"FIGURE 1: Schematic summary of the different sample preparation approaches of the monograph following United States Pharmacopeia (USP) procedures and the postulated headspace-SIFT-MS alternative.","_key":"8ffe5f2d33120"}],"_type":"block","style":"normal"}],"_key":"60fa4ef09344","asset":{"_ref":"image-4e710fc42a5310da95d6d387530b4626b209e433-1152x612-png","_type":"reference"},"widthP":100,"blank":true,"disableTextWrap":false,"disableLightBox":false,"_type":"figure"},{"_key":"72eaca9bb8af","markDefs":[],"children":[{"marks":[],"text":"The SIFT-MS Technique","_key":"4157aa328ae4","_type":"span"}],"_type":"block","style":"h2"},{"markDefs":[],"children":[{"_type":"span","marks":[],"text":"Compared to conventional chromatographic techniques, SIFT-MS is a direct-injection MS technique (6). Briefly, rapidly switchable reagent ions (H","_key":"7117a0dbb4480"},{"_key":"731e75e10f6c","_type":"span","marks":["subscript"],"text":"3"},{"marks":[],"text":"O","_key":"b45ae1e66696","_type":"span"},{"_type":"span","marks":["superscript"],"text":"+","_key":"67a251f5b928"},{"text":", NO","_key":"c01e9d13b24e","_type":"span","marks":[]},{"_key":"98a10bebb65f","_type":"span","marks":["superscript"],"text":"+"},{"_type":"span","marks":[],"text":" and O","_key":"99a4fcf0d3e1"},{"_key":"13248a98b981","_type":"span","marks":["subscript"],"text":"2"},{"marks":["superscript"],"text":"+","_key":"473f53e2dc64","_type":"span"},{"_type":"span","marks":[],"text":") obtained from a microwave discharge in the air are used for gas-phase soft chemical ionization of volatile organic compounds (VOCs) in the headspace. Real-time, high-throughput analysis of chemically diverse volatile compounds is achieved because SIFT-MS is chromatography-free. Selectivity is achieved through the combination of multiple ionization mechanisms, courtesy of rapid switching between reagent ions providing independent measurements of each analyte, and mass spectrometric detection. The current work used a SIFT-MS instrument operating on helium carrier gas.","_key":"01de35b2b5a0"}],"_type":"block","style":"normal","_key":"9c8aee2ec6da"},{"children":[{"_type":"span","marks":[],"text":"Experimental","_key":"ba9c70c33c97"}],"_type":"block","style":"h2","_key":"deb5ef20b3c1","markDefs":[]},{"style":"normal","_key":"26fb0b8ed401","markDefs":[],"children":[{"_type":"span","marks":[],"text":"Automated headspace-SIFT-MS analysis was achieved using an instrument comprising a Syft Tracer i3 (Syft Technologies, New Zealand), a multipurpose autosampler (PAL RSI, CTC Analytics AG, Switzerland), and SyftAuditTracer software (Syft Technologies, New Zealand). Samples were incubated at 70 °C for 30 min in an agitator. Headspace was sampled using a 2.5-mL headspace syringe (heated to 120 °C) and subsequently injected at a flow rate of 25 μL/ s into the SIFT-MS instrument’s high-throughput (HTP) inlet (heated to 120 °C). Since the nominal sample flow into the SIFT-MS instrument is 420 μL/s, a make-up gas (ultra-high purity nitrogen) is introduced into the inlet. The 10-fold dilution is accounted for in the calibration procedure below. The analysis time for each sample was 120 s and the reported concentrations are the mean of the values obtained during injection. Note that no internal standard was used (7).","_key":"6c8df22712e00"}],"_type":"block"},{"style":"normal","_key":"3f51d1e941b7","markDefs":[],"children":[{"_type":"span","marks":["em"],"text":"Sample Preparation: ","_key":"40ac4f732c3c"},{"_type":"span","marks":[],"text":"PEG samples were prepared by weighing 100 mg of each PEG (PEG 400, PEG 8000 (Spectrum) and PEG 200, Sigma-Aldrich) and PS (Tween 20 and 80, Sigma-Aldrich) into a 20-mL headspace vial. Solutions were brought up to 2.2 mL with water. Samples were incubated at 70 °C for 30 min, and then 2.5 mL of headspace was injected into the Syft Tracer i3 at an injection rate of 25 μL s 1, using a syringe temperature of 120°C. The high-throughput inlet on the SIFT-MS was also maintained at 120 °C.","_key":"2997b3b2c6d8"}],"_type":"block"},{"markDefs":[],"children":[{"_type":"span","marks":[],"text":"Standards for ethylene oxide and 1,4-dioxane were prepared in 20 mL headspace vials at a final concentration of 500 ng/mL in water. This is equivalent to 10 ppm, which is the acceptable limit for both volatiles in pharmaceutical excipients according to ","_key":"e62d1ccb2a410"},{"_type":"span","marks":["em"],"text":"USP","_key":"b5c19f64d65c"},{"text":" \u003c228\u003e.","_key":"38e224b2e413","_type":"span","marks":[]}],"_type":"block","style":"normal","_key":"df17071b888d"},{"_type":"block","style":"h2","_key":"01a416665c9d","markDefs":[],"children":[{"_key":"9aaa365d45ab","_type":"span","marks":[],"text":"SIFT-MS Detection of Ethylene\nOxide and 1,4-Dioxane"}]},{"_key":"8501ab01e7af","markDefs":[],"children":[{"_type":"span","marks":[],"text":"Table I summarizes the reagent ion–product ion pairs used to quantify ethylene oxide and 1,4-dioxane in this study.","_key":"a2e7c2b8f1560"}],"_type":"block","style":"normal"},{"disableLightBox":false,"_type":"figure","_key":"6eb138386c37","asset":{"_ref":"image-bf331fca0595c8ae14132dd395bd0faf0560b83f-862x1020-png","_type":"reference"},"widthP":100,"blank":true,"disableTextWrap":false},{"style":"normal","_key":"d595ab9fe990","markDefs":[],"children":[{"_type":"span","marks":[],"text":"Ethylene oxide is readily detected using SIFT-MS (Table I). While the NO","_key":"dec35493c9c80"},{"_type":"span","marks":["superscript"],"text":"+","_key":"2c135f7a1dad"},{"_key":"087e30a7db0d","_type":"span","marks":[],"text":" reagent ion is significantly less reactive with ethylene oxide than the O"},{"marks":["subscript"],"text":"2","_key":"ee6cbebd4608","_type":"span"},{"marks":["superscript"],"text":"+","_key":"7380f8df221d","_type":"span"},{"_type":"span","marks":[],"text":" reagent ions, the product ions of the O","_key":"8f1e188d4699"},{"_type":"span","marks":["subscript"],"text":"2","_key":"34883eab6bf5"},{"_type":"span","marks":["superscript"],"text":"+","_key":"45f71cfd77c4"},{"_type":"span","marks":[],"text":" reagent ions have mass-to-charge ratios that are frequently observed product ions for other VOCs and are unhelpful in practice. The most sensitive product ion (the ","_key":"9a289aeb3bcb"},{"_type":"span","marks":["em"],"text":"m/z ","_key":"5b95edcfba51"},{"_type":"span","marks":[],"text":"45 ion resulting from reaction with H","_key":"81262ed75857"},{"_type":"span","marks":["subscript"],"text":"3","_key":"44079e6dd912"},{"_key":"49739076de97","_type":"span","marks":[],"text":"O"},{"_type":"span","marks":["superscript"],"text":"+","_key":"801d5a0f59e0"},{"_type":"span","marks":[],"text":") is subject to regular interference by acetaldehyde. Because PEG samples will typically have low levels of ethylene oxide—and especially because this work aims to leverage maximum sensitivity to reduce sample size and mitigate matrix effects—a subtraction approach is utilized. The H","_key":"f1f875679e15"},{"_type":"span","marks":["subscript"],"text":"3","_key":"e89ee39d87cb"},{"_type":"span","marks":[],"text":"O","_key":"f66127ee1f8a"},{"_type":"span","marks":["superscript"],"text":"+","_key":"5808f2861d44"},{"_type":"span","marks":[],"text":" reagent ion is used to measure the combined ethylene oxide and acetaldehyde concentration and NO","_key":"a03c577bd8bd"},{"marks":["superscript"],"text":"+","_key":"b788946f9c5c","_type":"span"},{"_type":"span","marks":[],"text":" is used to measure the acetaldehyde concentration, enabling ethylene oxide to be determined by subtraction of the latter value from the former.","_key":"e1402d51cdee"}],"_type":"block"},{"_type":"block","style":"h2","_key":"c29d07380f14","markDefs":[],"children":[{"_key":"8761449e5bb7","_type":"span","marks":[],"text":"Results and Discussion"}]},{"markDefs":[],"children":[{"marks":[],"text":"To evaluate linearity of ethylene oxide, a standard curve was run from 50–200 ng/mL of ethylene oxide in water (Figure 2a). Acetaldehyde concentrations are also reported simply to show that no acetaldehyde is detected using the NO","_key":"bc4b658256010","_type":"span"},{"_type":"span","marks":["superscript"],"text":"+","_key":"6e2c9756255c"},{"_key":"8f7c489c3089","_type":"span","marks":[],"text":" 43 ion for quantification because this ion is unique to acetaldehyde only. To evaluate detectability, 100 mg of PEG was spiked with ethylene oxide at 80%, 100% and 120% of the accepted limit (8 ppm, 10 ppm, and 12 ppm, respectively). Figure 2b shows the increase in measured ethylene oxide with rising concentration, demonstrating detectability as required for validation of limits tests per USP. The limit of quantitation (LOQ) for ethylene oxide was calculated as 28 ng/mL (equivalent to approximately 0.5 ppm), which is approximately 20 times lower than the limits outlined in USP \u003c228\u003e, using 1/10 of the sample typically required with the GC–FID method."}],"_type":"block","style":"normal","_key":"32bc96d59013"},{"asset":{"_ref":"image-b055be265a1d481ae514e8ddc52f76b52e2fd764-1308x494-png","_type":"reference"},"widthP":100,"blank":true,"disableTextWrap":false,"disableLightBox":false,"_type":"figure","imgcaption":[{"children":[{"_type":"span","marks":[],"text":"FIGURE 2: Linear detection and effective discrimination of ethylene oxide from acetaldehyde in PEG samples using headspace-SIFT-MS.","_key":"5487e34c979f0"}],"_type":"block","style":"normal","_key":"53db62a2f5a8","markDefs":[]}],"_key":"bce279a29653"},{"children":[{"marks":[],"text":"Both ethylene oxide and 1,4-dioxane were quantified in three different PEG samples: PEG 400, PEG 8000 and PEG 200. Two polysorbate (PS) samples were also prepared in the same way, as previous data has shown the ability quantify ethylene oxide and 1,4-dioxane in PS prepared in water, using SIFT-MS. Figure 3 shows ethylene oxide levels plotted as a percentage of the limit (10 ppm) in the three PEG samples and two polysorbate samples. For comparison, several of the PEG samples were prepared using the standard GC–FID preparation, where the PEG was “stripped” (i.e., rotovapped for 6 h to remove VOCs from the matrix). The data show some remaining ethylene oxide present in the stripped PEG 400 sample. The spiked PEG 400 sample, which was prepared by stripping the PEG and adding ethylene oxide at its limit, measured very closely with the standard prepared in water. Ethylene oxide was not detected in the PEG 200 or either of the PS samples.","_key":"0b61005129910","_type":"span"}],"_type":"block","style":"normal","_key":"7356b091c96b","markDefs":[]},{"_key":"af79f9e0e7b8","asset":{"_ref":"image-7e262e67a7ad281a5a089bc5526e22f5e58513b7-872x584-png","_type":"reference"},"widthP":100,"blank":true,"disableTextWrap":false,"disableLightBox":false,"_type":"figure","imgcaption":[{"children":[{"_type":"span","marks":[],"text":"FIGURE 3: Amount of ethylene oxide in PEG 400, PEG 8000, PEG 200, PS 20, and PS 80 plotted as a percentage of the limit allowed in USP \u003c228\u003e.","_key":"7b86dc7cf8650"}],"_type":"block","style":"normal","_key":"6bcb720bd7c7","markDefs":[]}]},{"style":"normal","_key":"7cea39c87435","markDefs":[],"children":[{"_key":"56476631229d0","_type":"span","marks":[],"text":"As was seen with ethylene oxide, the 1,4-dioxane data in Figure 4 shows both the dioxane standard in water, and prepared in the spiked PEG 400 sample, near the limit of 10 ppm. Some remaining 1,4-dioxane was detected in PEG 200, albeit at a significantly lower level than was present in the unstripped sample. A substantially higher level of 1,4-dioxane was measured in the PS 80 sample: almost four times the allowable limit. This sample is research-grade PS 80, and not of the purity that is used as a pharmaceutical excipient."}],"_type":"block"},{"_type":"figure","imgcaption":[{"style":"normal","_key":"274beb560461","markDefs":[],"children":[{"_type":"span","marks":[],"text":"FIGURE 4: Amount of ethylene oxide in PEG 400, PEG 8000, PEG 200, PS 20, and PS 80 plotted as a percentage of the limit allowed in USP \u003c228\u003e.","_key":"89741667d06e0"}],"_type":"block"}],"_key":"c0f861ed22de","asset":{"_ref":"image-fc9dd5c6afdad574d785fb571c1c6d2a84d683a3-868x488-png","_type":"reference"},"widthP":100,"blank":true,"disableTextWrap":false,"disableLightBox":false},{"children":[{"_type":"span","marks":[],"text":"Conclusions","_key":"b5c84f0db297"}],"_type":"block","style":"h2","_key":"490071bae406","markDefs":[]},{"markDefs":[],"children":[{"text":"The findings from the current study show that high-sensitivity headspace-SIFT-MS analysis allows linear detection of ethylene oxide and effectively discriminates against its major interferent: acetaldehyde. The LOQ for ethylene oxide was calculated to be 0.5 ppm, which is well below the acceptance criteria outlined in USP \u003c228\u003e. The higher sensitivity of SIFT-MS enables use of 10-fold lower mass of sample compared to GC–FID, enabling 6-h prep of matrix-matched standards to be eliminated, as the effect from matrix becomes negligible. A single-point calibration using an external standard prepared in water can be used. SIFT-MS successfully measured both ethylene oxide and 1,4-dioxane in several PEG samples, and revealed that “stripped” PEG, which has undergone a rotovap step to remove volatiles, is not volatile-free, as ethylene oxide and 1,4-dioxane were detected in some of the “stripped” PEG samples due to the increased sensitivity provided by SIFT-MS.","_key":"b324c5f4d5890","_type":"span","marks":[]}],"_type":"block","style":"normal","_key":"b88c619f10cd"},{"_key":"34570591709a","markDefs":[],"children":[{"_key":"3b939f9cb97c0","_type":"span","marks":[],"text":"Headspace-SIFT-MS analysis of ethylene oxide is 9- to 14-fold faster than the compendial GC–FID method, yielding sample throughputs of up to 224 samples/day. Shorter and simpler sample preparation when combined with faster analysis of SIFT-MS enables delivery of the first test result eight-fold faster than GC–FID. Headspace-SIFT-MS is an industry-proven technology ready for the QA/QC laboratory and process line."}],"_type":"block","style":"normal"},{"_type":"block","style":"h2","_key":"5b2ed6d71ece","markDefs":[],"children":[{"_type":"span","marks":[],"text":"References","_key":"034a3ddc51a3"}]},{"_type":"block","style":"normal","_key":"b6ed54d747b1","markDefs":[],"children":[{"text":"(1) United States Environmental Protection Agency (US EPA). Available online: Ethylene Oxide Emissions: Frequent Questions | US EPA.","_key":"9e4ee35a4e17","_type":"span","marks":[]}]},{"children":[{"text":"(2) Aronson, J.K., Ethylene oxide. In Meyler’s Side Effects of Drugs, 16th ed., Elsevier, pp 198-202 (2016). ","_key":"6b715ae7bfc8","_type":"span","marks":[]},{"_type":"span","marks":["beca0c6d9a57"],"text":"https://www.clinicalkey.com/#!/content/book/3-s2.0-B9780444537171007137","_key":"095fcd0bdff2"}],"_type":"block","style":"normal","_key":"b149597ffcdf","markDefs":[{"nofollow":true,"blank":true,"_type":"link","href":"https://www.clinicalkey.com/#!/content/book/3-s2.0-B9780444537171007137","_key":"beca0c6d9a57"}]},{"children":[{"marks":[],"text":"(3) United States Pharmacopeia. Polysorbate 80. 2015. ","_key":"674bb55a55aa","_type":"span"},{"_key":"0ed8f562141b","_type":"span","marks":["09a514d0f796"],"text":"https://www.usp.org/sites/default/files/usp/document/harmonization/excipients/polysorbate_80.pdf"},{"_type":"span","marks":[],"text":" (Accessed June 26, 2024)","_key":"279896ba4ac0"}],"_type":"block","style":"normal","_key":"bdcfefe16230","markDefs":[{"nofollow":true,"blank":true,"_type":"link","href":"https://www.usp.org/sites/default/files/usp/document/harmonization/excipients/polysorbate_80.pdf","_key":"09a514d0f796"}]},{"children":[{"_type":"span","marks":[],"text":"(4) United States Pharmacopeia. \u003c228\u003e Ethylene Oxide and Dioxane. 2013.","_key":"95c1fe9cb1ff"}],"_type":"block","style":"normal","_key":"553355fd9f36","markDefs":[]},{"markDefs":[{"blank":true,"_type":"link","href":"https://bit.ly/3QLWRmC","_key":"70ed42f60a6d","nofollow":true}],"children":[{"text":"(5) Silva, L.; Connor, A.; Bastian, C.; Williams, C.; Morseth, Z.; Franco, E. 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","_key":"c29514e3c5b6"},{"_type":"span","marks":["strong"],"text":"Leslie Silva","_key":"33dd1b91c127"},{"_type":"span","marks":[],"text":" is Applications Team Lead at Syft Technologies Inc in Anaheim, CA, USA. ","_key":"5958c3cb885d"},{"marks":["strong"],"text":"Chad Bastian","_key":"84055d9dfbe70","_type":"span"},{"text":" is Principal Scientist, ","_key":"bb4123150502","_type":"span","marks":[]},{"text":"Christopher Williams","_key":"a6116b442cc6","_type":"span","marks":["strong"]},{"text":" is Senior Director of Laboratory Services, and ","_key":"dd41e70efcff","_type":"span","marks":[]},{"_type":"span","marks":["strong"],"text":"Alyssa McBurney","_key":"04bedcb9deb1"},{"_type":"span","marks":[],"text":" is Senior Scientist at Alcami Corporation in Wilmington, NC, USA. ","_key":"24c53ee58601"},{"marks":["strong"],"text":"Mark Perkins","_key":"7fc9bfa6ea830","_type":"span"},{"_type":"span","marks":[],"text":" is Senior Applications Chemist at Element Lab Solutions in Cambridge, UK.","_key":"b9cea3388e2a"}],"_type":"block","style":"normal","_key":"5b27c22a754b"}],"articleType":"News","ExcludeFromPubMedXML":false,"title":"Rapid Quantitative Analysis of Ethylene Oxide and 1,4-Dioxane in Polymeric Excipients Using SIFT-Mass Spectrometry","thumbnail":{"_type":"mainImage","alt":"Molecule of ethylene oxide, ball-and-stick molecular model. Scientific 3d rendering | Image Credit: © Alexey Novikov - stock.adobe.com","caption":"Molecule of ethylene oxide, ball-and-stick molecular model. Scientific 3d rendering | Image Credit: © Alexey Novikov - stock.adobe.com","asset":{"_ref":"image-3145743408cce26e88e6381a7320ac324bff3abb-6000x4000-jpg","_type":"reference"}},"summary":"Pharmaceutical excipients, such as polyethylene glycol-based polymers, must be tested for the presence of ethylene oxide (EtO) and 1,4-dioxane as part of a safety assessment, according to USP Chapter \u003c228\u003e.","taxonomyMapping":[{"name":"Mass Spectrometry","_updatedAt":"2020-08-01T11:11:48Z","pixelTrackingCode":null,"_createdAt":"2020-07-15T15:48:03Z","_rev":"4Q6wgk7hVHKTxcqSyD1Qm2","_type":"taxonomy","_id":"chroma_taxonomy_2584_massspectrometry","identifier":"topic/mass-spectrometry","parent":{"name":"Topic","_createdAt":"2020-07-15T15:48:03Z","_rev":"J34BMvlUIWrjsIqgLxmpXQ","parent":null,"_type":"taxonomy","_id":"chroma_taxonomy_38471_topic","_updatedAt":"2023-09-20T16:52:32Z","identifier":"topic","isMainTopic":true}},{"_updatedAt":"2020-08-01T11:11:48Z","parent":{"_id":"chroma_taxonomy_38471_topic","identifier":"topic","isMainTopic":true,"_type":"taxonomy","parent":null,"name":"Topic","_updatedAt":"2023-09-20T16:52:32Z","_createdAt":"2020-07-15T15:48:03Z","_rev":"J34BMvlUIWrjsIqgLxmpXQ"},"_createdAt":"2020-07-15T15:48:03Z","_rev":"4Q6wgk7hVHKTxcqSyD1Qoj","_type":"taxonomy","name":"Pharmaceutical Analysis","_id":"chroma_taxonomy_38290_pharmaceuticalanalysis","identifier":"topic/pharmaceutical-analysis-2","pixelTrackingCode":null},{"_type":"taxonomy","name":"Gas Chromatography (GC)","_id":"chroma_taxonomy_2642_gaschromatographygc","parent":{"_type":"taxonomy","_id":"chroma_taxonomy_38471_topic","_updatedAt":"2023-09-20T16:52:32Z","identifier":"topic","isMainTopic":true,"_rev":"J34BMvlUIWrjsIqgLxmpXQ","_createdAt":"2020-07-15T15:48:03Z","name":"Topic","parent":null},"pixelTrackingCode":null,"_createdAt":"2020-07-15T15:48:03Z","_rev":"4Q6wgk7hVHKTxcqSyD1Qm2","_updatedAt":"2020-08-01T11:11:48Z","identifier":"topic/gas-chromatography-gc"}],"factCheckAuthors":null,"display_summary":false,"url":"rapid-quantitative-analysis-of-ethylene-oxide-and-1-4-dioxane-in-polymeric-excipients-using-sift-mass-spectrometry","published":"2024-11-11T13:03:00.000Z","is_visible":true,"documentGroupMapping":null,"authorMapping":[{"lastName":"Mathew","displayName":"Juby Mathew","_createdAt":"2024-08-08T13:11:44Z","_rev":"eDTVperG1nxWB45NbheSlm","_type":"author","_id":"901ed58e-b562-45cb-a476-09cd6563aab7","biography":[{"style":"normal","_key":"6bacef821ec1","markDefs":[],"children":[{"_key":"db7129bfd0750","_type":"span","marks":["strong"],"text":"Juby Mathew"},{"text":" is Life Sciences Market Specialist at Syft Technologies in Christchurch, New Zealand.","_key":"68af48ff99cf","_type":"span","marks":[]}],"_type":"block"}],"url":{"current":"juby-mathew","_type":"slug"},"firstName":"Juby","_updatedAt":"2024-08-08T13:11:44Z"},{"_createdAt":"2024-05-07T14:40:51Z","_type":"author","_id":"94607c6c-0884-47a3-8ce5-250f5c6a1437","biography":[{"markDefs":[{"_type":"emailAddress","href":"leslie.silva@syft.com","_key":"84638632e1e8"}],"children":[{"_type":"span","marks":["strong"],"text":"Leslie Silva","_key":"490e76986ade0"},{"marks":[],"text":" is an applications scientist at Syft Technologies in the United States. She joined Syft in 2020 after completing her PhD in biochemistry and molecular biology at the University of Calgary, a postdoctoral fellowship at MD Anderson Cancer Center, and research positions at Lawrence Berkeley National Laboratory and a food \u0026 beverage start-up, Endless West. She has 23 peer-reviewed publications and numerous patents, application notes, and conference papers. Direct correspondence to: ","_key":"c3092e87d4fe","_type":"span"},{"_type":"span","marks":["84638632e1e8"],"text":"leslie.silva@syft.com","_key":"9d8cbc89a45e"}],"_type":"block","style":"normal","_key":"97dd7118c94e"}],"_updatedAt":"2024-05-07T14:44:44Z","url":{"current":"leslie-p-silva","_type":"slug"},"firstName":"Leslie","lastName":"Silva","displayName":"Leslie P. 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Mark graduated from the University of Southampton, UK, with a Ph.D. in electrochemistry. He was with the Malaysian Rubber Board’s UK research centre for 12 years, first as a senior analyst, then as head of the analytical section. He joined Element in early 2015 in a role that supports and expands the analytical capability of SIFT-MS—with a particular focus on autosampler integration and the development of automated test methods. Direct correspondence: ","_key":"038467affebc","_type":"span","marks":[]},{"text":"mark.perkins@element.com","_key":"91d5600ab8bc","_type":"span","marks":["e47bf14db7c5"]}],"_type":"block","style":"normal","_key":"5019fff8915b","markDefs":[{"_type":"emailAddress","href":"mark.perkins@element.com","_key":"e47bf14db7c5"}]}],"extraURL2":"","lastName":"Perkins","_createdAt":"2020-04-21T13:14:05Z","state":"","email":"","address1":"","facebook":"","linkedIn":"","url":{"_type":"slug","current":"mark-j-perkins"},"_rev":"JQyFWN0OP2CS2wVWcxslQb","_id":"chroma_author_360315","extraURL3":"","displayName":"Mark J. Perkins","website":"","firstName":"Mark","country":"","_updatedAt":"2023-06-08T18:19:36Z","_type":"author","extraURL1":"","middleName":"J.","twitter":""},{"zip":"","firstName":"Vaughan","extraURL1":"","email":"","website":"","address2":"","facebook":"","_type":"author","country":"","displayName":"Vaughan S. Langford","_updatedAt":"2023-06-08T18:19:14Z","extraURL2":"","_id":"chroma_author_360313","biography":[{"children":[{"_key":"dbb0a7ad30b9","_type":"span","marks":["strong"],"text":"Vaughan Langford"},{"marks":[],"text":" is a principal scientist at Syft Technologies in New Zealand. He joined Syft in late 2002 after completing his Ph.D. in physical chemistry at the University of Canterbury, and postdoctoral fellowships at the Universities of Geneva, Western Australia, and Canterbury. He has over 30 peer-reviewed publications on a wide range of SIFT-MS applications, and has contributed numerous conference papers. Direct correspondence: ","_key":"a909ef341045","_type":"span"},{"_type":"span","marks":["63ee39609183"],"text":"vaughan.langford@syft.com","_key":"90e337cfec0c"}],"_type":"block","style":"normal","_key":"a763325880ba","markDefs":[{"href":"vaughan.langford@syft.com","_key":"63ee39609183","_type":"emailAddress"}]}],"url":{"current":"vaughan-s-langford","_type":"slug"},"extraURL3":"","linkedIn":"","middleName":"S.","city":"","_createdAt":"2020-04-21T13:14:05Z","company":"","state":"","address1":"","lastName":"Langford","_rev":"xIRGrKPm5iTJNmzQW5cVYq","twitter":""}],"abstract":[{"_key":"45ab9f608eba","markDefs":[],"children":[{"text":"Pharmaceutical excipients, such as polyethylene glycol-based polymers, must be tested for the presence of ethylene oxide (EtO) and 1,4-dioxane as part of a safety assessment, according to USP Chapter \u003c228\u003e. Selected ion flow tube mass spectrometry (SIFT-MS) offers advantages over conventional GC methods and accelerates quantitative and selective analysis of EtO and 1,4-dioxane through elimination of a lengthy matrix-match preparation and shorter run times providing 9- to 14-fold higher daily throughput than gas chromatography (GC). These efficiencies are gained while maintaining high analytical sensitivity, using 10-fold less sample per analysis.","_key":"057b896beb230","_type":"span","marks":["strong"]}],"_type":"block","style":"normal"}],"contentCategory":{"name":"Articles","_id":"8bdaa7fc-960a-4b57-b076-75fdce3741bb","_updatedAt":"2020-08-01T07:40:33Z","_createdAt":"2020-04-09T07:45:20Z","_rev":"4Q6wgk7hVHKTxcqSyCnygb","_type":"contentCategory"},"pageNumber":"14–19","seoTag":["Gas Chromatography (GC)","Mass Spectrometry","Pharmaceutical Analysis"],"showSocialShare":true,"_rev":"t9EQ0nkXnwA0WYtTuXgOaa","_createdAt":"2024-11-11T12:58:32Z","documentGroup":null,"targeting":{"content_placement":["topic/mass-spectrometry","topic/pharmaceutical-analysis-2","topic/gas-chromatography-gc"],"document_url":["rapid-quantitative-analysis-of-ethylene-oxide-and-1-4-dioxane-in-polymeric-excipients-using-sift-mass-spectrometry"],"document_group":null,"rootDocumentGroup":[],"issue_url":"","publication_url":""},"relatedArticles":[{"title":"Best of the Week: EAS 2024 Awardees, Oligonucleotides in Drug Development, and More","url":{"current":"best-of-the-week-eas-2024-awardees-oligonucleotides-in-drug-development-and-more","_type":"slug"},"thumbnail":{"_type":"mainImage","asset":{"_ref":"image-188f060f8e226e80446f85f1fdd3c3b187d38833-845x266-jpg","_type":"reference"}},"published":"2024-11-22T14:52:33.534Z"},{"title":"Rising Stars of Separation Science 2024","url":{"_type":"slug","current":"rising-stars-of-separation-science-2024"},"thumbnail":{"_type":"mainImage","alt":"Rising Stars of Separation Science 2024 ","asset":{"_ref":"image-8d44c273c472b751c853ea437f1263ad2280aadf-552x368-jpg","_type":"reference"}},"published":"2024-11-20T05:06:00.000Z"},{"title":"GC Troubleshooting in 20 Pictures – Part 2","url":{"current":"gc-troubleshooting-in-20-pictures-part-2","_type":"slug"},"thumbnail":{"_type":"mainImage","alt":"GC Troubleshooting in 20 Pictures – Part 2","asset":{"_ref":"image-b76601e451657f5c4c1aaa33ed296cd1ea8cf4d2-552x368-jpg","_type":"reference"}},"published":"2024-11-19T05:00:00.000Z"},{"title":"RAFA 2024 Highlights: Contemporary Food Contamination Analysis Using Chromatography","url":{"current":"rafa-2024-highlights-contemporary-food-contamination-analysis-using-chromatography","_type":"slug"},"thumbnail":{"_type":"mainImage","asset":{"_ref":"image-6443e6d1598a61e2a595434c48ba745084203f00-1248x1540-png","_type":"reference"}},"published":"2024-11-18T13:00:00.000Z"},{"title":"Best of the Week: Emerging Chromatography Leader, Bladder Cancer Research, and HPLC 2025","url":{"current":"best-of-the-week-emerging-chromatography-leader-bladder-cancer-research-and-hplc-2025","_type":"slug"},"thumbnail":{"_type":"mainImage","asset":{"_type":"reference","_ref":"image-188f060f8e226e80446f85f1fdd3c3b187d38833-845x266-jpg"}},"published":"2024-11-15T16:25:25.054Z"},{"title":"In Bruges: HPLC 2025","url":{"current":"in-bruges-hplc-2025","_type":"slug"},"thumbnail":{"_type":"mainImage","alt":"Canals of Bruges, Belgium | Image Credit: © gqxue - stock.adobe.com","caption":"Canals of Bruges, Belgium | Image Credit: © gqxue - stock.adobe.com","asset":{"_ref":"image-0aa31539c817c805fe12018157a1e8171b6150fa-3600x2400-jpg","_type":"reference"}},"published":"2024-11-13T14:47:02.302Z"}]},{"issueGroup":{"_ref":"315e4e0f-39b3-4f9c-b4f2-49422d9170a4","_type":"reference"},"body":[{"children":[{"_type":"span","marks":[],"text":"A recent study led by scientists from the Mithibai College of Arts in Mumbai, India shows the effects of using a modified version of liquid chromatography-tandem mass spectrometry (LC–MS/MS) for detecting nitrosamines in Olmesartan tablets. Their findings were published in the ","_key":"f10dfeea19ef0"},{"_type":"span","marks":["em"],"text":"Journal of Chromatography A ","_key":"f10dfeea19ef1"},{"_type":"span","marks":[],"text":"(1).","_key":"f10dfeea19ef2"}],"_type":"block","style":"normal","_key":"0588830c8d18","markDefs":[]},{"alt":"Digital blood pressure monitor and medical pills on the white table. Healthcare and medicine concept | Image Credit: ©Lazy_Bear - stock.adobe.com","imgcaption":[{"_key":"f6815bef290d","markDefs":[],"children":[{"marks":[],"text":"Digital blood pressure monitor and medical pills on the white table. Healthcare and medicine concept | Image Credit: ©Lazy_Bear - stock.adobe.com","_key":"26fe5296a5100","_type":"span"}],"_type":"block","style":"normal"}],"_key":"9b77665c4e71","asset":{"_ref":"image-58352ec1f223f0f661d6a54f78b174cb3d0d81a5-5000x3333-jpg","_type":"reference"},"disableTextWrap":false,"disableLightBox":false,"_type":"figure"},{"children":[{"_type":"span","marks":[],"text":"Mutagenic and carcinogenic substances, which can cause health risks to humans, including increasing cancer risks, typically stem from the manufacturing processes of drugs, food processing, and water treatment. N–Nitroso compounds, which are known for mutagenic and carcinogenic properties, have been found in various products, including dairy, vegetables, alcoholic beverages, and meats. These compounds can also appear in pharmaceutical products. N–nitrosamines are viewed as genotoxic impurities that can directly or indirectly damage cellular DNA. In particular, the U.S. Food and Drug Administration (FDA) highlighted N–Nitrosodimethylamine (NDMA), N–Nitrosodiethylamine (NDEA), N–Nitroso-N-methyl-4-aminobutyric acid (NMBA), N–Nitrosoisopropylethylamine (NEIPA), N–Nitrosodiisopropylamine (NDIPA), and N–Nitrosomethylphenylamine (NMPA). NDMA, NDEA, NMBA, NEIPA, and NMPA have been detected in drug substances or products, with NDMA and NDEA specifically being primary nitrosamine contaminants whose presences have led to immediate recalls of pharmaceutical products from the market.","_key":"47db5d8e76480"}],"_type":"block","style":"normal","_key":"e73a0c168129","markDefs":[]},{"style":"normal","_key":"c97a8dd8bd20","markDefs":[],"children":[{"_key":"53d6b394c9030","_type":"span","marks":[],"text":"In this study, liquid chromatography-tandem mass spectrometry (LC–MS/MS) was tested for concurrently measuring nitrosamines in Olmesartan tablets, which are used to treat high blood pressure. Olmesartan works by blocking substances in the body that cause blood vessels to tighten (2). As such, Olmesartan relaxes the blood vessels, lowering blood pressure and increasing the supply of blood and oxygen to the heart."}],"_type":"block"},{"markDefs":[],"children":[{"_type":"span","marks":[],"text":"LC–MS/MS offers minimal sample consumption, suitability for thermally labile analytes, and heightened sensitivity for detecting nitrosamines in pharmaceutical matrices. Conventional LC–MS/MS often needs extensive and time-consuming sample preparation, though this was addressed in this study by developing more efficient and streamlined sample preparation that reduced variability and improved recovery rates, the scientists wrote. With this method, internal standards were not needed to overcome problems while analyzing nitrosamines.","_key":"70eb1277715f0"}],"_type":"block","style":"normal","_key":"4bc304344b9a"},{"markDefs":[],"children":[{"_type":"span","marks":[],"text":"The method applied effective chromatographic separation and optimized parameters for mass spectrometric detection. Detection was carried out using APCI positive ion mode. Chromatographic separation was achieved using a Thermo Accucore PFP column (150 mm x 4.6 mm, 2.6 µ), with a simple gradient elution of mobile phase consisting of 0.1% formic acid in water (mobile phase A) and methanol (mobile phase B). The total run time was 20 min, with a flow rate of 0.800 mL/min.","_key":"9044b99aa4a70"}],"_type":"block","style":"normal","_key":"af2e55b5158d"},{"_key":"cccb7b14598a","markDefs":[],"children":[{"_type":"span","marks":[],"text":"Overall, the established method showed excellent linearity (R","_key":"13ddd52815e50"},{"_key":"0ab53892f267","_type":"span","marks":["superscript"],"text":"2"},{"_type":"span","marks":[],"text":" \u003e 0.99) and sensitivity for all the nitrosamines. The detection and quantification limits were sufficiently low for trace nitrosamine levels, hold good signal-to-noise (S/N) ratios. When tested on Olmesartan tablet samples, the method showed good accuracy, with recovery ranges between 80–120%. This new analytical approach showed notable repeatability and reliability, making it possible to precisely quantify nitrosamine levels in Olmesartan tablets in a single analytical run. This work can help pave the way for more significant advancements, allowing for the facilitation of more precise and accurate analysis in routine quality control analysis.","_key":"505b99e0503b"}],"_type":"block","style":"normal"},{"_key":"370d39f6da2b","markDefs":[],"children":[{"_type":"span","marks":[],"text":"References","_key":"f39dd0609b340"}],"_type":"block","style":"h2"},{"style":"normal","_key":"8b81a238f86e","markDefs":[{"_type":"link","href":"https://doi.org/10.1016/j.chroma.2024.465176","_key":"a021f050aa1e"}],"children":[{"_type":"span","marks":[],"text":"(1) Pawar, N.; Bhardwaj, A.; Vora, A.; Sharma, S. A Multianalyte LC-MS/MS Method for accurate Quantification of Nitrosamines in Olmesartan Tablets. ","_key":"fb64c2bae9e1"},{"marks":["em"],"text":"J. Chromatogr. A ","_key":"f39dd0609b341","_type":"span"},{"_type":"span","marks":["strong"],"text":"2024, ","_key":"f39dd0609b342"},{"_key":"f39dd0609b343","_type":"span","marks":["em"],"text":"1732, "},{"_type":"span","marks":[],"text":"465176. DOI: ","_key":"f39dd0609b344"},{"_type":"span","marks":["a021f050aa1e"],"text":"10.1016/j.chroma.2024.465176","_key":"f39dd0609b345"}],"_type":"block"},{"_type":"block","style":"normal","_key":"4e34cdc4851d","markDefs":[{"_key":"472aded56502","_type":"link","href":"https://www.mayoclinic.org/drugs-supplements/olmesartan-oral-route/side-effects/drg-20065169?p=1"}],"children":[{"marks":[],"text":"(2) Olmesartan (Oral Route). May Foundation for Medical Education and Research (MFMER) 2024. ","_key":"33e10d343d9d0","_type":"span"},{"_type":"span","marks":["472aded56502"],"text":"https://www.mayoclinic.org/drugs-supplements/olmesartan-oral-route/side-effects/drg-20065169?p=1","_key":"33e10d343d9d1"},{"_type":"span","marks":[],"text":" (accessed 2024-8-15)","_key":"33e10d343d9d2"}]}],"is_visible":true,"authorMapping":[{"lastName":"Acevedo","_type":"author","_id":"ce622919-d02c-4efe-8b39-cebf525eeb45","biography":[{"_type":"block","style":"normal","_key":"3c9e248b4d2d","markDefs":[{"_type":"emailAddress","href":"aacevedo@mjhlifesciences.com","_key":"bf8a4034f6fb"}],"children":[{"text":"Aaron Acevedo","_key":"cc33296cdb1f","_type":"span","marks":["strong"]},{"_type":"span","marks":[],"text":" is the Assistant Editor for ","_key":"82faa471c1c5"},{"_type":"span","marks":["em"],"text":"LCGC","_key":"3bf43517a910"},{"_type":"span","marks":[],"text":" and ","_key":"8a27e057b7d8"},{"marks":["em"],"text":"Spectroscopy.","_key":"5cc63048dd74","_type":"span"},{"text":" Direct correspondence to: ","_key":"5b1f6c399d48","_type":"span","marks":[]},{"_type":"span","marks":["bf8a4034f6fb"],"text":"aacevedo@mjhlifesciences.com","_key":"7880a6065027"}]}],"_updatedAt":"2023-07-05T18:14:42Z","url":{"current":"aaron-acevedo","_type":"slug"},"firstName":"Aaron","displayName":"Aaron Acevedo","_createdAt":"2023-02-22T20:12:44Z","_rev":"uQERtADC3rE6YG7nfvXXT7","middleName":"Rey"}],"summary":"Mithibai College of Arts scientists recently used liquid chromatography-tandem mass spectrometry (LC–MS/MS) for detecting nitrosamines in blood pressure medication.","showSocialShare":true,"_rev":"nPzAxY6bjYDfdrdPKlR86o","documentGroupMapping":null,"factCheckAuthors":null,"contentCategory":{"_id":"8bdaa7fc-960a-4b57-b076-75fdce3741bb","_updatedAt":"2020-08-01T07:40:33Z","_createdAt":"2020-04-09T07:45:20Z","_rev":"4Q6wgk7hVHKTxcqSyCnygb","_type":"contentCategory","name":"Articles"},"_updatedAt":"2024-11-07T18:10:00Z","_id":"260ce569-4c74-4682-9c1d-8aa1d5c271fc","articleType":"News","pageNumber":"32","ExcludeFromPubMedXML":false,"_type":"article","taxonomyMapping":[{"identifier":"topic/liquid-chromatography-lchplc","parent":{"_createdAt":"2020-07-15T15:48:03Z","_type":"taxonomy","_id":"chroma_taxonomy_38471_topic","_updatedAt":"2023-09-20T16:52:32Z","parent":null,"identifier":"topic","isMainTopic":true,"_rev":"J34BMvlUIWrjsIqgLxmpXQ","name":"Topic"},"_updatedAt":"2020-08-01T11:11:48Z","pixelTrackingCode":null,"_createdAt":"2020-07-15T15:48:03Z","_rev":"4Q6wgk7hVHKTxcqSyD1Qm2","_type":"taxonomy","name":"Liquid Chromatography (LC/HPLC)","_id":"chroma_taxonomy_2131_liquidchromatographylchplc"},{"_createdAt":"2020-07-15T15:48:03Z","_id":"chroma_taxonomy_2584_massspectrometry","_updatedAt":"2020-08-01T11:11:48Z","identifier":"topic/mass-spectrometry","pixelTrackingCode":null,"_rev":"4Q6wgk7hVHKTxcqSyD1Qm2","_type":"taxonomy","name":"Mass Spectrometry","parent":{"parent":null,"_updatedAt":"2023-09-20T16:52:32Z","isMainTopic":true,"_type":"taxonomy","_rev":"J34BMvlUIWrjsIqgLxmpXQ","name":"Topic","_id":"chroma_taxonomy_38471_topic","identifier":"topic","_createdAt":"2020-07-15T15:48:03Z"}},{"parent":{"_createdAt":"2020-07-15T15:48:03Z","name":"Topic","_id":"chroma_taxonomy_38471_topic","identifier":"topic","isMainTopic":true,"parent":null,"_rev":"J34BMvlUIWrjsIqgLxmpXQ","_type":"taxonomy","_updatedAt":"2023-09-20T16:52:32Z"},"_rev":"4Q6wgk7hVHKTxcqSyD1Qoj","pixelTrackingCode":null,"name":"LC–MS","_id":"chroma_taxonomy_38282_lcms","_updatedAt":"2020-08-01T11:11:48Z","identifier":"topic/lc-ms","_createdAt":"2020-07-15T15:48:03Z","_type":"taxonomy"},{"parent":{"_type":"taxonomy","_id":"chroma_taxonomy_38471_topic","identifier":"topic","_rev":"J34BMvlUIWrjsIqgLxmpXQ","name":"Topic","_updatedAt":"2023-09-20T16:52:32Z","parent":null,"isMainTopic":true,"_createdAt":"2020-07-15T15:48:03Z"},"pixelTrackingCode":null,"_createdAt":"2020-07-15T15:48:03Z","_type":"taxonomy","_id":"chroma_taxonomy_38239_biologicalmedicalandclinicalanalysis","identifier":"topic/biological-medical-and-clinical-analysis","_rev":"4Q6wgk7hVHKTxcqSyD1Qoj","name":"Biological, Medical, and Clinical Analysis","_updatedAt":"2020-08-01T11:11:48Z"},{"_updatedAt":"2020-08-01T11:11:48Z","identifier":"topic/pharmaceutical-analysis-2","_rev":"4Q6wgk7hVHKTxcqSyD1Qoj","_type":"taxonomy","_id":"chroma_taxonomy_38290_pharmaceuticalanalysis","parent":{"_updatedAt":"2023-09-20T16:52:32Z","identifier":"topic","isMainTopic":true,"_createdAt":"2020-07-15T15:48:03Z","_rev":"J34BMvlUIWrjsIqgLxmpXQ","_type":"taxonomy","name":"Topic","_id":"chroma_taxonomy_38471_topic","parent":null},"_createdAt":"2020-07-15T15:48:03Z","name":"Pharmaceutical Analysis","pixelTrackingCode":null}],"title":"LC–MS/MS for Quantifying Nitrosamines in Olmesartan Tablets","thumbnail":{"_type":"mainImage","alt":"Digital blood pressure monitor and medical pills on the white table. 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","_key":"8d231a0f20f81","_type":"span"},{"_type":"span","marks":[],"text":"(1).","_key":"8d231a0f20f82"}],"_type":"block","style":"normal","_key":"66d0cbdbbbd2","markDefs":[]},{"_key":"6f2d7463615d","asset":{"_ref":"image-ee0995fcd02a37971efec9205192900b9642070c-6000x4000-jpg","_type":"reference"},"disableTextWrap":false,"disableLightBox":false,"_type":"figure","alt":"Vaporiser des plantes dans un jardin, jardinage entretien et protection contres les pucerons et les maladies | Image Credit: © Delphotostock - stock.adobe.com","imgcaption":[{"markDefs":[],"children":[{"_key":"de999f1602120","_type":"span","marks":[],"text":"Vaporiser des plantes dans un jardin, jardinage entretien et protection contres les pucerons et les maladies | Image Credit: © Delphotostock - stock.adobe.com"}],"_type":"block","style":"normal","_key":"ea50a668b360"}]},{"children":[{"_type":"span","marks":["em"],"text":"Angelica sinensis, ","_key":"13bd832f8e0b0"},{"marks":[],"text":"also known as dong quai root, is a TCM that has been used for more than 1000 years as a spice, tonic, and medicine in China, Korea, and Japan (2). Sometimes referred to as “female ginseng,” dong quai has been combined with other herbs to treat women’s reproductive problems, such as painful menstruation, and to improve blood flow.","_key":"13bd832f8e0b1","_type":"span"}],"_type":"block","style":"normal","_key":"259140c5efbe","markDefs":[]},{"markDefs":[],"children":[{"marks":[],"text":"Pesticides are often used in cultivating ","_key":"0125f66b16e80","_type":"span"},{"_key":"0125f66b16e81","_type":"span","marks":["em"],"text":"Angelica sinensis "},{"_type":"span","marks":[],"text":"to prevent and control brown spot and root rot; however, currently isobutyl urea and fludioxonil are registered and allowed to be used on said plant. A recent study reported 14 pesticides being detected in ","_key":"0125f66b16e82"},{"text":"Angelica sinesis, ","_key":"0125f66b16e83","_type":"span","marks":["em"]},{"marks":[],"text":"including 5 banned pesticides (3). The plant is susceptible to contamination by various mycotoxins, such as aflatoxin and ochratoxin, during planting, harvesting, and storage.","_key":"0125f66b16e84","_type":"span"}],"_type":"block","style":"normal","_key":"b95dd95e78cd"},{"style":"normal","_key":"63a30c5c9bf0","markDefs":[],"children":[{"_type":"span","marks":[],"text":"In this study, the scientists developed an applicable method that could determine 33 pesticides (54 compounds), 11 mycotoxins, and functional compounds, such as ferulic acid, simultaneously. The sample pretreatment method’s compatibility for pesticides, mycotoxins, and functional components was improved by optimizing the acidity of extraction solvents, the volumetric solution, and more. Four pretreatment methods were compared with the PRiME HLB SPE pretreatment method being deemed the most optimal. This SPE product is said to provide reversed-phase cleanup of acidic, basic, and neutral compounds forming complex sample matrices, having been designed to simplify SPE with easy-to-follow protocols (4). Among 65 contaminants, 38 of which were determined by liquid chromatography (LC) and 41 via gas chromatography (GC), which showed good linearity (R2 \u003e 0.9801), 97% of them had a limit of quantitation (LOQ) of lower than 0.02 mg kg-1. Recovery for all compounds were suited between 70–120%, with relative standard deviations (RSD) being all lower than 20% at the spiked levels of LOQ, 2 × LOQ, and 10 × LOQ. For ferulic acid, the LOQ was 50 ng/mL, with good linearity (R2=0.9988) be9jg shown within the range of 0.5–10 µg/mL. The recovery and RSD were 98.1 %, and 3.2 % (","_key":"dd005de39c7c0"},{"_type":"span","marks":["em"],"text":"n","_key":"dd005de39c7c1"},{"_type":"span","marks":[],"text":" = 6), respectively.","_key":"dd005de39c7c2"}],"_type":"block"},{"_type":"block","style":"normal","_key":"cbec409ae4fa","markDefs":[],"children":[{"_key":"5f9d0afe84e20","_type":"span","marks":[],"text":"The team developed a method for the simultaneous determination of pesticides, mycotoxins, and ferulic acid in "},{"_key":"5f9d0afe84e21","_type":"span","marks":["em"],"text":"Angelica sinensis "},{"_type":"span","marks":[],"text":"via high-resolution mass spectrometry (HRMS). This method met the monitoring requirements of the Chinese Pharmacopoeia with high efficiency and rapidity. By optimizing purification technology, extraction acidity, and constant volume solution, the scientists designed a comprehensive scheme that can be compatible with various detection techniques for different types of compounds, they wrote Moving forward, this method could potentially be extended to more categories and analytes of TCM samples.","_key":"5f9d0afe84e22"}]},{"_key":"9d823c277bbc","markDefs":[],"children":[{"_type":"span","marks":[],"text":"References","_key":"c2e1a5c6b1f50"}],"_type":"block","style":"h2"},{"children":[{"_type":"span","marks":[],"text":"(1) Bai, R.; Chang, Q.; Zhang, H.; et al. Simultaneous Determination of Pesticides, Mycotoxins and Ferulic Acid in ","_key":"2c51a6fa449a0"},{"_type":"span","marks":["em"],"text":"Angelica sinensis","_key":"2c51a6fa449a1"},{"_type":"span","marks":[],"text":" by GC/LC-Q-TOF/MS. ","_key":"2c51a6fa449a2"},{"_key":"2c51a6fa449a3","_type":"span","marks":["em"],"text":"J. Chromatogr. 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FeMS is a community-led group that has developed a network of support for women working in mass spectrometry. For years, FeMS has supported events all over the world where women in mass spectrometry can gather and discuss their findings and career experiences.","_key":"67cdf999c25f0"}],"_type":"block","style":"normal","_key":"ebecd38c19d8"},{"_type":"block","style":"normal","_key":"6a902de4120e","markDefs":[],"children":[{"_type":"span","marks":[],"text":"This quarter, FeMS presented Empowerment Awards to five women, including Faith Johnson of ECOLAB, who joined FeMS in June 2024. ","_key":"59b1a00f4e4a0"},{"_type":"span","marks":["em"],"text":"LCGC International ","_key":"59b1a00f4e4a1"},{"text":"recently sat down with Johnson to discuss her career in climate science, how mass spectrometry relates to her field, the award, and her work with FeMS.","_key":"59b1a00f4e4a2","_type":"span","marks":[]}]},{"_type":"figure","_key":"45b090886437","asset":{"_ref":"image-99c6fbbe2824a68b5900b244dc83d6133af65420-1080x1920-jpg","_type":"reference"},"disableTextWrap":false,"disableLightBox":false},{"_type":"block","style":"normal","_key":"d6596ac1efb9","markDefs":[],"children":[{"_type":"span","marks":["strong"],"text":"How does analytical science help in addressing climate change?","_key":"5a9fe63f04610"}]},{"markDefs":[],"children":[{"_key":"175026ece1d30","_type":"span","marks":[],"text":"Analytical science plays a vital role in adapting to climate change by providing essential data and insights into environmental changes. Techniques such as chromatography, mass spectrometry, and spectroscopy enable researchers to monitor pollutants, track greenhouse gas emissions, and assess the health of ecosystems. This information is crucial for developing effective strategies and policies to mitigate climate impacts and enhance resilience."}],"_type":"block","style":"normal","_key":"339079f7d542"},{"style":"normal","_key":"d7162c2f3e06","markDefs":[],"children":[{"_key":"6a6a74ebfbed0","_type":"span","marks":[],"text":""}],"_type":"block"},{"children":[{"_type":"span","marks":["strong"],"text":"How has mass spectrometry (MS) been useful in environmental and climate analysis?","_key":"0e0a28a0e9e40"}],"_type":"block","style":"normal","_key":"f213a6954688","markDefs":[]},{"children":[{"_type":"span","marks":[],"text":"Mass spectrometry (MS) is invaluable in environmental and climate analysis due to its sensitivity and ability to detect trace levels of contaminants. It is used to analyze pollutants in air, water, and soil, helping researchers identify sources of pollution and assess the impact on ecosystems and human health. Additionally, MS assists in isotopic analysis, providing insights into historical climate data and informing future climate models.","_key":"03d4716ea8fe0"}],"_type":"block","style":"normal","_key":"0891d72f6298","markDefs":[]},{"children":[{"_type":"span","marks":[],"text":"","_key":"e619696dadaa0"}],"_type":"block","style":"normal","_key":"4ebd043644df","markDefs":[]},{"_type":"block","style":"normal","_key":"271306e30cec","markDefs":[],"children":[{"_type":"span","marks":["strong"],"text":"What advice would you give to other scientists who are looking to find mentors and make connections across the industry?","_key":"d95d2fef7aa30"}]},{"_type":"block","style":"normal","_key":"a47cc5be9613","markDefs":[],"children":[{"_type":"span","marks":[],"text":"I recommend actively seeking mentorship by attending industry conferences, participating in networking events, and joining professional organizations. 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