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Impurity And Degradant Control | Lhasa Limited

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data-dce-background-image-url="https://www.lhasalimited.org/wp-content/uploads/2022/11/solutions-banner-v2-scaled.jpg" class="elementor-section elementor-top-section elementor-element elementor-element-2ee7b7f elementor-section-height-min-height elementor-section-items-top elementor-section-boxed elementor-section-height-default" data-id="2ee7b7f" data-element_type="section" data-settings="{&quot;background_background&quot;:&quot;classic&quot;,&quot;jet_parallax_layout_list&quot;:[]}"> <div class="elementor-background-overlay"></div> <div class="elementor-container elementor-column-gap-default"> <div class="elementor-column elementor-col-50 elementor-top-column elementor-element elementor-element-3ba08a7" data-id="3ba08a7" data-element_type="column"> <div class="elementor-widget-wrap elementor-element-populated"> <div class="elementor-element elementor-element-080f62d elementor-widget elementor-widget-heading" data-id="080f62d" data-element_type="widget" data-widget_type="heading.default"> <div class="elementor-widget-container"> <h1 class="elementor-heading-title elementor-size-default">Impurity and degradant control</h1> </div> </div> <div class="elementor-element elementor-element-0ea9fcc elementor-widget elementor-widget-text-editor" data-id="0ea9fcc" data-element_type="widget" data-widget_type="text-editor.default"> <div class="elementor-widget-container"> <p>Supporting your identification and control of impurities in Active Pharmaceutical Ingredients (APIs) and drug product</p> </div> </div> <div class="elementor-element elementor-element-7cef40e elementor-widget elementor-widget-button" data-id="7cef40e" data-element_type="widget" data-widget_type="button.default"> <div class="elementor-widget-container"> <div class="elementor-button-wrapper"> <a class="elementor-button elementor-button-link elementor-size-sm" href="/contact-us"> <span class="elementor-button-content-wrapper"> <span class="elementor-button-text">Get in touch</span> </span> </a> </div> </div> </div> </div> </div> <div class="elementor-column elementor-col-50 elementor-top-column elementor-element elementor-element-d0a3f51" data-id="d0a3f51" data-element_type="column"> <div class="elementor-widget-wrap"> </div> </div> </div> </section> <section class="elementor-section elementor-top-section elementor-element elementor-element-cc0a4aa elementor-section-boxed elementor-section-height-default elementor-section-height-default" data-id="cc0a4aa" data-element_type="section" data-settings="{&quot;background_background&quot;:&quot;classic&quot;,&quot;jet_parallax_layout_list&quot;:[]}"> <div class="elementor-container elementor-column-gap-default"> <div class="elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-f06d1ef" data-id="f06d1ef" data-element_type="column"> <div class="elementor-widget-wrap elementor-element-populated"> <section class="elementor-section elementor-inner-section elementor-element elementor-element-b8a7074 elementor-section-boxed elementor-section-height-default elementor-section-height-default" data-id="b8a7074" data-element_type="section" data-settings="{&quot;jet_parallax_layout_list&quot;:[]}"> <div class="elementor-container elementor-column-gap-default"> <div class="elementor-column elementor-col-100 elementor-inner-column elementor-element elementor-element-41e4ccd" data-id="41e4ccd" data-element_type="column"> <div class="elementor-widget-wrap elementor-element-populated"> <div class="elementor-element elementor-element-e030678 elementor-widget elementor-widget-text-editor" data-id="e030678" data-element_type="widget" data-widget_type="text-editor.default"> <div class="elementor-widget-container"> <p>Identification and control of impurities and degradants in active pharmaceutical ingredients (APIs) and pharmaceutical drug products is a critical aspect of the drug development process when assessing chemical safety.</p> </div> </div> <div class="elementor-element elementor-element-4b70f1a elementor-widget elementor-widget-text-editor" data-id="4b70f1a" data-element_type="widget" data-widget_type="text-editor.default"> <div class="elementor-widget-container"> <p>Mutagenic impurities of drug products can complicate formulation, lengthen the drug development timeline, and impact shelf life due to growth of degradation products.</p><p>Several regulations now call for greater reporting and control on impurities and degradants in drug substances at lower level based on the threshold of toxicological concern and daily dose.</p> </div> </div> </div> </div> </div> </section> </div> </div> </div> </section> <section class="elementor-section elementor-top-section elementor-element elementor-element-b2900a3 elementor-section-boxed elementor-section-height-default elementor-section-height-default elementor-invisible" data-id="b2900a3" data-element_type="section" data-settings="{&quot;background_background&quot;:&quot;classic&quot;,&quot;jet_parallax_layout_list&quot;:[],&quot;animation&quot;:&quot;rotateInUpLeft&quot;}"> <div class="elementor-container elementor-column-gap-default"> <div class="elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-b2f5c43" data-id="b2f5c43" data-element_type="column"> <div class="elementor-widget-wrap elementor-element-populated"> <div class="elementor-element elementor-element-15379e1 elementor-widget elementor-widget-heading" data-id="15379e1" data-element_type="widget" data-widget_type="heading.default"> <div class="elementor-widget-container"> <h2 class="elementor-heading-title elementor-size-default">Our solution</h2> </div> </div> <div class="elementor-element elementor-element-2846919 elementor-widget elementor-widget-text-editor" data-id="2846919" data-element_type="widget" data-widget_type="text-editor.default"> <div class="elementor-widget-container"> <p>We can support you in accurately assessing the risk of potential mutagenic impurities and degradants, using our <em>in silico</em> software solutions Mirabilis and Zeneth.</p> </div> </div> <section class="elementor-section elementor-inner-section elementor-element elementor-element-87e6f57 elementor-section-boxed elementor-section-height-default elementor-section-height-default" data-id="87e6f57" data-element_type="section" data-settings="{&quot;jet_parallax_layout_list&quot;:[]}"> <div class="elementor-container elementor-column-gap-default"> <div class="elementor-column elementor-col-50 elementor-inner-column elementor-element elementor-element-cd8676c" data-id="cd8676c" data-element_type="column"> <div class="elementor-widget-wrap elementor-element-populated"> <div class="elementor-element elementor-element-ff2e256 dce_masking-none elementor-widget elementor-widget-image" data-id="ff2e256" data-element_type="widget" data-settings="{&quot;motion_fx_motion_fx_mouse&quot;:&quot;yes&quot;}" data-widget_type="image.default"> <div class="elementor-widget-container"> <a href="#Mirabilis"> <img decoding="async" width="1024" height="381" src="https://www.lhasalimited.org/wp-content/uploads/2022/11/mirabilis-logo-1024x381.png" class="elementor-animation-hang attachment-large size-large wp-image-2672" alt="mirabilis logo" srcset="https://www.lhasalimited.org/wp-content/uploads/2022/11/mirabilis-logo-1024x381.png 1024w, https://www.lhasalimited.org/wp-content/uploads/2022/11/mirabilis-logo-300x112.png 300w, https://www.lhasalimited.org/wp-content/uploads/2022/11/mirabilis-logo-768x286.png 768w, https://www.lhasalimited.org/wp-content/uploads/2022/11/mirabilis-logo-1536x571.png 1536w, https://www.lhasalimited.org/wp-content/uploads/2022/11/mirabilis-logo-2048x762.png 2048w" sizes="(max-width: 1024px) 100vw, 1024px"> </a> </div> </div> </div> </div> <div class="elementor-column elementor-col-50 elementor-inner-column elementor-element elementor-element-a34d392" data-id="a34d392" data-element_type="column"> <div class="elementor-widget-wrap elementor-element-populated"> <div class="elementor-element elementor-element-fafd314 dce_masking-none elementor-widget elementor-widget-image" data-id="fafd314" data-element_type="widget" data-settings="{&quot;motion_fx_motion_fx_mouse&quot;:&quot;yes&quot;}" data-widget_type="image.default"> <div class="elementor-widget-container"> <a href="#Zeneth"> <img decoding="async" width="2068" height="769" src="https://www.lhasalimited.org/wp-content/uploads/2022/11/zeneth-logo.png" class="elementor-animation-hang attachment-full size-full wp-image-2673" alt="zeneth logo" srcset="https://www.lhasalimited.org/wp-content/uploads/2022/11/zeneth-logo.png 2068w, https://www.lhasalimited.org/wp-content/uploads/2022/11/zeneth-logo-300x112.png 300w, https://www.lhasalimited.org/wp-content/uploads/2022/11/zeneth-logo-1024x381.png 1024w, https://www.lhasalimited.org/wp-content/uploads/2022/11/zeneth-logo-768x286.png 768w, https://www.lhasalimited.org/wp-content/uploads/2022/11/zeneth-logo-1536x571.png 1536w, https://www.lhasalimited.org/wp-content/uploads/2022/11/zeneth-logo-2048x762.png 2048w" sizes="(max-width: 2068px) 100vw, 2068px"> </a> </div> </div> </div> </div> </div> </section> <div class="elementor-element elementor-element-5c60773 elementor-widget elementor-widget-menu-anchor" data-id="5c60773" data-element_type="widget" data-widget_type="menu-anchor.default"> <div class="elementor-widget-container"> <div class="elementor-menu-anchor" id="Mirabilis"></div> </div> </div> </div> </div> </div> </section> <section data-dce-background-color="#FFFFFF" class="elementor-section elementor-top-section elementor-element elementor-element-9db86ec elementor-section-full_width elementor-section-height-default elementor-section-height-default" data-id="9db86ec" data-element_type="section" data-settings="{&quot;jet_parallax_layout_list&quot;:[],&quot;background_background&quot;:&quot;gradient&quot;}"> <div class="elementor-container elementor-column-gap-default"> <div class="elementor-column elementor-col-25 elementor-top-column elementor-element elementor-element-86936ca" data-id="86936ca" data-element_type="column"> <div class="elementor-widget-wrap"> </div> </div> <div class="elementor-column elementor-col-25 elementor-top-column elementor-element elementor-element-8bac952" data-id="8bac952" data-element_type="column"> <div class="elementor-widget-wrap elementor-element-populated"> <div class="elementor-element elementor-element-979d0fa dce_masking-none elementor-widget elementor-widget-image" data-id="979d0fa" data-element_type="widget" data-widget_type="image.default"> <div class="elementor-widget-container"> <img loading="lazy" decoding="async" width="1269" height="356" src="https://www.lhasalimited.org/wp-content/uploads/2022/11/MIRABILIS_LOGO.png" class="attachment-full size-full wp-image-1811" alt="MIRABILIS LOGO" srcset="https://www.lhasalimited.org/wp-content/uploads/2022/11/MIRABILIS_LOGO.png 1269w, https://www.lhasalimited.org/wp-content/uploads/2022/11/MIRABILIS_LOGO-300x84.png 300w, https://www.lhasalimited.org/wp-content/uploads/2022/11/MIRABILIS_LOGO-1024x287.png 1024w, https://www.lhasalimited.org/wp-content/uploads/2022/11/MIRABILIS_LOGO-768x215.png 768w" sizes="(max-width: 1269px) 100vw, 1269px"> </div> </div> <div class="elementor-element elementor-element-587833a elementor-widget elementor-widget-text-editor" data-id="587833a" data-element_type="widget" data-widget_type="text-editor.default"> <div class="elementor-widget-container"> <p><strong>Mirabilis</strong> provides an industry-standardised approach for calculating purge factors of potentially mutagenic impurities. Using Mirabilis can help you to evaluate carry-over risk for potentially mutagenic impurities in drug substance synthesis.</p> </div> </div> </div> </div> <div class="elementor-column elementor-col-25 elementor-top-column elementor-element elementor-element-939990b" data-id="939990b" data-element_type="column" data-settings="{&quot;background_background&quot;:&quot;classic&quot;}"> <div class="elementor-widget-wrap elementor-element-populated"> <div class="elementor-element elementor-element-e7963d9 elementor-widget elementor-widget-heading" data-id="e7963d9" data-element_type="widget" data-widget_type="heading.default"> <div class="elementor-widget-container"> <h2 class="elementor-heading-title elementor-size-default">Mirabilis highlights</h2> </div> </div> <div class="elementor-element elementor-element-24167e1 elementor-widget elementor-widget-text-editor" data-id="24167e1" data-element_type="widget" data-widget_type="text-editor.default"> <div class="elementor-widget-container"> <p><span style="color: #333f48;"><strong>Manage your impurity risk</strong><br /></span><span style="font-weight: 400;">A risk assessment tool to assist with the <a href="https://www.lhasalimited.org/10-tips-for-controlling-your-potentially-mutagenic-impurities-outside-the-lab/">management of your potential mutagenic impurities (PMIs)</a>, Mirabilis generates a reactivity purge factor for the impurities based on empirical data, and provides predictions for reactivity, solubility and volatility purges. Mirabilis can calculate the purge required to eliminate an impurity and determine the purge ratio, to identify if Option 4 is the best control strategy as per ICH M7.</span></p> </div> </div> <div class="elementor-element elementor-element-2b94eab elementor-widget elementor-widget-text-editor" data-id="2b94eab" data-element_type="widget" data-widget_type="text-editor.default"> <div class="elementor-widget-container"> <p><strong><span style="color: #333f48;">Predict reactivity, solubility, and volatility purge factors</span></strong><br /><span style="font-weight: 400;">Reactivity predictions are provided by Mirabilis based on the actual reagents and conditions which are confirmed by the user. Mirabilis </span><span style="font-weight: 400;">also includes a calculator for solubility purges which is applied for extractions and can help provide the additional supporting information </span><span style="font-weight: 400;">for such purges. In addition, a volatility calculator is included to allow volatility purges to be applied based on the impurity’s boiling point as well as the operational temperature and pressure, or solvent being removed.</span></p> </div> </div> <div class="elementor-element elementor-element-f4d4132 elementor-widget elementor-widget-text-editor" data-id="f4d4132" data-element_type="widget" data-widget_type="text-editor.default"> <div class="elementor-widget-container"> <p><strong><span style="color: #333f48;">Align with industry and regulatory approach</span></strong><br /><span style="font-weight: 400;">Mirabilis provides an industry-standardised approach for calculating purge factors of potentially mutagenic impurities. To aid in regulatory </span><span style="font-weight: 400;">submission, Mirabilis allows you to create a report that includes the predicted purge calculation, scientific rationale and supporting </span><span style="font-weight: 400;">evidence. Mirabilis members also have the chance to interact and exchange knowledge and experiences at regular conferences </span><span style="font-weight: 400;">promoted by Lhasa.</span></p> </div> </div> <div class="elementor-element elementor-element-ac56e3a elementor-align-left elementor-widget elementor-widget-button" data-id="ac56e3a" data-element_type="widget" data-widget_type="button.default"> <div class="elementor-widget-container"> <div class="elementor-button-wrapper"> <a class="elementor-button elementor-button-link elementor-size-sm" href="/contact-us"> <span class="elementor-button-content-wrapper"> <span class="elementor-button-text">Get in touch</span> </span> </a> </div> </div> </div> <div class="elementor-element elementor-element-48519b5 elementor-widget elementor-widget-menu-anchor" data-id="48519b5" data-element_type="widget" data-widget_type="menu-anchor.default"> <div class="elementor-widget-container"> <div class="elementor-menu-anchor" id="Zeneth"></div> </div> </div> </div> </div> <div class="elementor-column elementor-col-25 elementor-top-column elementor-element elementor-element-4e8b95b" data-id="4e8b95b" data-element_type="column"> <div class="elementor-widget-wrap"> </div> </div> </div> </section> <section class="elementor-section elementor-top-section elementor-element elementor-element-3c9638a elementor-section-full_width elementor-section-height-default elementor-section-height-default" data-id="3c9638a" data-element_type="section" data-settings="{&quot;jet_parallax_layout_list&quot;:[]}"> <div class="elementor-container elementor-column-gap-default"> <div class="elementor-column elementor-col-25 elementor-top-column elementor-element elementor-element-6f3fd64" data-id="6f3fd64" data-element_type="column"> <div class="elementor-widget-wrap"> </div> </div> <div class="elementor-column elementor-col-25 elementor-top-column elementor-element elementor-element-519ffe0" data-id="519ffe0" data-element_type="column"> <div class="elementor-widget-wrap elementor-element-populated"> <div class="elementor-element elementor-element-779afbf dce_masking-none elementor-widget elementor-widget-image" data-id="779afbf" data-element_type="widget" data-widget_type="image.default"> <div class="elementor-widget-container"> <img loading="lazy" decoding="async" width="2644" height="803" src="https://www.lhasalimited.org/wp-content/uploads/2022/11/ZENETH_LOGO.png" class="attachment-full size-full wp-image-1812" alt="ZENETH LOGO" srcset="https://www.lhasalimited.org/wp-content/uploads/2022/11/ZENETH_LOGO.png 2644w, https://www.lhasalimited.org/wp-content/uploads/2022/11/ZENETH_LOGO-300x91.png 300w, https://www.lhasalimited.org/wp-content/uploads/2022/11/ZENETH_LOGO-1024x311.png 1024w, https://www.lhasalimited.org/wp-content/uploads/2022/11/ZENETH_LOGO-768x233.png 768w, https://www.lhasalimited.org/wp-content/uploads/2022/11/ZENETH_LOGO-1536x466.png 1536w, https://www.lhasalimited.org/wp-content/uploads/2022/11/ZENETH_LOGO-2048x622.png 2048w" sizes="(max-width: 2644px) 100vw, 2644px"> </div> </div> <div class="elementor-element elementor-element-74b226c elementor-widget elementor-widget-text-editor" data-id="74b226c" data-element_type="widget" data-widget_type="text-editor.default"> <div class="elementor-widget-container"> <p><strong>Zeneth</strong> identifies forced degradation pathways of organic compounds, which can help you to characterise structures of degradants observed in forced degradation studies quickly.</p> </div> </div> </div> </div> <div data-dce-background-overlay-color="#FFFFFF" class="elementor-column elementor-col-25 elementor-top-column elementor-element elementor-element-32d46ed" data-id="32d46ed" data-element_type="column" data-settings="{&quot;background_background&quot;:&quot;classic&quot;}"> <div class="elementor-widget-wrap elementor-element-populated"> <div class="elementor-background-overlay"></div> <div class="elementor-element elementor-element-a2bc96f elementor-widget elementor-widget-heading" data-id="a2bc96f" data-element_type="widget" data-widget_type="heading.default"> <div class="elementor-widget-container"> <h2 class="elementor-heading-title elementor-size-default">Zeneth highlights</h2> </div> </div> <div class="elementor-element elementor-element-ac52112 elementor-widget elementor-widget-text-editor" data-id="ac52112" data-element_type="widget" data-widget_type="text-editor.default"> <div class="elementor-widget-container"> <p><strong><span style="color: #333f48;">Identify and assess degradants</span></strong><br /><span style="font-weight: 400;">Using its comprehensive knowledge of <a href="https://www.lhasalimited.org/predicting-forced-degradation-pathways-learning-how-to-get-the-most-out-of-zeneth/">degradation pathways</a>, Zeneth can swiftly provide predictions for likely degradation products of drug </span><span style="font-weight: 400;">compounds. In addition, drug-excipient interactions can be assessed to understand potential stability issues in the final formulated product.</span></p> </div> </div> <div class="elementor-element elementor-element-1401d30 elementor-widget elementor-widget-text-editor" data-id="1401d30" data-element_type="widget" data-widget_type="text-editor.default"> <div class="elementor-widget-container"> <p><span style="color: #333f48;"><strong>Enable informed decision making</strong><br /></span><span style="font-weight: 400;">Zeneth can be used in exploratory formulation departments to identify potential degradation problems with a drug at an early stage in the </span><span style="font-weight: 400;">drug development workflow. This early understanding can aid future decisions around experimental requirements as well as excipient selection.</span></p> </div> </div> <div class="elementor-element elementor-element-7253f81 elementor-widget elementor-widget-text-editor" data-id="7253f81" data-element_type="widget" data-widget_type="text-editor.default"> <div class="elementor-widget-container"> <p><span style="color: #333f48;"><strong>Manage regulatory submission</strong><br /></span><span style="font-weight: 400;">After processing a drug compound through Zeneth, a range of filters can be applied to provide a results tree that can be compared to experimental findings. Using the customisable report feature in Zeneth, users can create reports suitable for regulatory submission.</span></p> </div> </div> <div class="elementor-element elementor-element-cf6dcef elementor-align-left elementor-widget elementor-widget-button" data-id="cf6dcef" data-element_type="widget" data-widget_type="button.default"> <div class="elementor-widget-container"> <div class="elementor-button-wrapper"> <a class="elementor-button elementor-button-link elementor-size-sm" href="/contact-us"> <span class="elementor-button-content-wrapper"> <span class="elementor-button-text">Get in touch</span> </span> </a> </div> </div> </div> </div> </div> <div class="elementor-column elementor-col-25 elementor-top-column elementor-element elementor-element-ac5e799" data-id="ac5e799" data-element_type="column"> <div class="elementor-widget-wrap"> </div> </div> </div> </section> <section class="elementor-section elementor-top-section elementor-element elementor-element-b778c88 elementor-section-boxed elementor-section-height-default elementor-section-height-default" data-id="b778c88" data-element_type="section" data-settings="{&quot;jet_parallax_layout_list&quot;:[]}"> <div class="elementor-container elementor-column-gap-default"> <div class="elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-6599e52" data-id="6599e52" data-element_type="column"> <div class="elementor-widget-wrap elementor-element-populated"> <div class="elementor-element elementor-element-7520edd elementor-widget elementor-widget-heading" data-id="7520edd" data-element_type="widget" data-widget_type="heading.default"> <div class="elementor-widget-container"> <h2 class="elementor-heading-title elementor-size-default">Regulatory support</h2> </div> </div> <div class="elementor-element elementor-element-78bbc5f elementor-widget elementor-widget-text-editor" data-id="78bbc5f" data-element_type="widget" data-widget_type="text-editor.default"> <div class="elementor-widget-container"> <p>The prediction and control of impurities and degradants in drug substances is a key requirement for a number of chemical safety assessments and regulations:</p> </div> </div> <div class="elementor-element elementor-element-9475fbe elementor-position-left elementor-view-default elementor-mobile-position-top elementor-vertical-align-top elementor-widget elementor-widget-icon-box" data-id="9475fbe" data-element_type="widget" data-widget_type="icon-box.default"> <div class="elementor-widget-container"> <div class="elementor-icon-box-wrapper"> <div class="elementor-icon-box-icon"> <span class="elementor-icon elementor-animation-"> <svg xmlns="http://www.w3.org/2000/svg" xmlns:xlink="http://www.w3.org/1999/xlink" id="Layer_1" viewBox="0 0 408.85 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d="M203.94,120.63c15.7,0,31.4-.09,47.1,.04,9.09,.07,14.94,8.53,11.51,16.49-2.17,5.03-6.25,7.42-11.7,7.42-13.04,.01-26.08,0-39.12,0-18.36,0-36.72,.06-55.08-.03-9.39-.04-15.41-8.4-11.91-16.5,2.25-5.2,6.49-7.45,12.1-7.44,15.7,.04,31.4,.01,47.1,.01Z"></path><path class="cls-5" d="M300.27,333.02c7.91-8.36,14.75-15.78,21.8-23,5.94-6.09,11.98-12.1,18.19-17.9,7.21-6.74,17.75-3.92,20.24,5.25,1.19,4.38,0,8.28-3.11,11.37-16.24,16.1-32.5,32.19-48.93,48.09-4.94,4.79-11.44,4.66-16.53-.09-8.36-7.8-16.57-15.76-24.65-23.85-4.97-4.98-4.97-12.01-.42-16.85,4.5-4.79,11.53-5.04,16.85-.43,2.81,2.43,5.47,5.06,8.04,7.75,2.57,2.69,4.94,5.58,8.53,9.67Z"></path></svg> </span> </div> <div class="elementor-icon-box-content"> <h3 class="elementor-icon-box-title"> <span > ICH M7 </span> </h3> <p class="elementor-icon-box-description"> Mirabilis can be used to help satisfy ICH M7 Control Option 4 by producing an estimated reactivity, solubility and volatility purge factor for removal of the impurity by a synthetic process. As such, Mirabilis can reduce the need to set up costly and time-consuming analytical methods for the measurement of impurities that are unlikely to be present in the final drug product. Under ICH M7, potential degradation products likely to be present in the final drug product should be evaluated for mutagenic potential. Zeneth has comprehensive knowledge of degradation pathways which ensures structure elucidation of experimentally observed degradants. Zeneth considers reaction conditions, making its predictions consistent with the conditions that have to be tested according to the ICH guidelines: thermolytic, hydrolytic, oxidative, and photolytic. </p> </div> </div> </div> </div> <div class="elementor-element elementor-element-be2a56b elementor-position-left elementor-view-default elementor-mobile-position-top elementor-vertical-align-top elementor-widget elementor-widget-icon-box" data-id="be2a56b" data-element_type="widget" data-widget_type="icon-box.default"> <div class="elementor-widget-container"> <div class="elementor-icon-box-wrapper"> <div class="elementor-icon-box-icon"> <span class="elementor-icon elementor-animation-"> <svg xmlns="http://www.w3.org/2000/svg" xmlns:xlink="http://www.w3.org/1999/xlink" id="Layer_1" viewBox="0 0 408.85 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id="linear-gradient-4" x1="197.13" y1="-61.05" x2="213.1" y2="300.09" xlink:href="#linear-gradient"></linearGradient><linearGradient id="linear-gradient-5" x1="195.08" y1="-60.96" x2="211.05" y2="300.18" xlink:href="#linear-gradient"></linearGradient><linearGradient id="linear-gradient-6" x1="295.52" y1="-65.4" x2="311.48" y2="295.74" xlink:href="#linear-gradient"></linearGradient></defs><path class="cls-1" 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class="cls-4" d="M156.14,168.54c31.4,0,62.81-.03,94.21,.02,9.37,.01,15.35,7.7,12.43,15.86-1.74,4.86-5.36,7.45-10.43,8.01-1.32,.15-2.66,.07-3.99,.07-61.74,0-123.48,0-185.22,0-9.58,0-15.15-4.41-15.15-11.98,0-7.57,5.57-11.98,15.15-11.98,31,0,62.01,0,93.01,0Z"></path><path class="cls-2" d="M133.78,240.41c-24.34,0-48.67,.05-73.01-.03-9.21-.03-15.11-8.1-11.97-16.17,1.74-4.48,5.16-6.97,9.88-7.65,1.05-.15,2.12-.1,3.19-.1,48.14,0,96.28,0,144.42,0,6.84,0,11.48,2.92,13.19,8.19,2.58,7.97-3.11,15.66-11.88,15.73-15.03,.12-30.05,.03-45.08,.04-9.57,0-19.15,0-28.72,0Z"></path><path class="cls-3" d="M203.42,96.66c-15.7,0-31.4,.02-47.1,0-5.29,0-9.27-2.35-11.47-7.17-2-4.37-1.66-9,1.82-12.21,2.44-2.24,6.14-4.34,9.3-4.37,31.8-.32,63.6-.24,95.4-.15,6.91,.02,12.03,5.22,12.13,11.75,.1,6.69-5.1,12.05-12.18,12.1-15.97,.12-31.93,.04-47.9,.04Z"></path><path class="cls-6" d="M203.94,120.63c15.7,0,31.4-.09,47.1,.04,9.09,.07,14.94,8.53,11.51,16.49-2.17,5.03-6.25,7.42-11.7,7.42-13.04,.01-26.08,0-39.12,0-18.36,0-36.72,.06-55.08-.03-9.39-.04-15.41-8.4-11.91-16.5,2.25-5.2,6.49-7.45,12.1-7.44,15.7,.04,31.4,.01,47.1,.01Z"></path><path class="cls-5" d="M300.27,333.02c7.91-8.36,14.75-15.78,21.8-23,5.94-6.09,11.98-12.1,18.19-17.9,7.21-6.74,17.75-3.92,20.24,5.25,1.19,4.38,0,8.28-3.11,11.37-16.24,16.1-32.5,32.19-48.93,48.09-4.94,4.79-11.44,4.66-16.53-.09-8.36-7.8-16.57-15.76-24.65-23.85-4.97-4.98-4.97-12.01-.42-16.85,4.5-4.79,11.53-5.04,16.85-.43,2.81,2.43,5.47,5.06,8.04,7.75,2.57,2.69,4.94,5.58,8.53,9.67Z"></path></svg> </span> </div> <div class="elementor-icon-box-content"> <h3 class="elementor-icon-box-title"> <span > ICH Q3B </span> </h3> <p class="elementor-icon-box-description"> The ICH Q3B (Impurities in New Drug Products) guideline provides guidance on the qualification of impurities in new drug substances produced by chemical syntheses. Zeneth can be used to help satisfy requirements under ICH Q3B, as it predicts the forced degradation pathways of organic compounds under various environmental conditions and, supports the identification and assessment of potential degradants whilst considering the effect of excipients and impurities. </p> </div> </div> </div> </div> <div class="elementor-element elementor-element-6cb6886 elementor-position-left elementor-view-default elementor-mobile-position-top elementor-vertical-align-top elementor-widget elementor-widget-icon-box" data-id="6cb6886" data-element_type="widget" data-widget_type="icon-box.default"> <div class="elementor-widget-container"> <div class="elementor-icon-box-wrapper"> <div class="elementor-icon-box-icon"> <span class="elementor-icon elementor-animation-"> <svg xmlns="http://www.w3.org/2000/svg" xmlns:xlink="http://www.w3.org/1999/xlink" id="Layer_1" viewBox="0 0 408.85 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d="M320.22,408.92H31.98c-.35-.18-.69-.45-1.06-.52C11.66,404.77,.06,390.91,.06,371.17,.02,284.28,.06,197.39,0,110.5c0-4.55,1.41-8.23,4.6-11.45C35.83,67.62,67.03,36.16,98.2,4.67,101.39,1.45,105.06,0,109.61,0c54.68,.06,109.36,.01,164.04,.1,3.68,0,7.49,.37,11.02,1.36,17.54,4.9,27.55,18.39,27.55,36.83,.02,57.75,0,115.5,0,173.25v4.78c1.9,.12,3.34,.19,4.78,.31,41.71,3.66,70.73,24.68,86.05,63.76,2.96,7.56,3.91,15.92,5.78,23.91v15.97c-.28,1.42-.6,2.82-.84,4.25-6.18,37.73-26.87,64.02-62.44,78.04-8.04,3.17-16.88,4.29-25.35,6.36Zm-101.97-120.59h-4.87c-50.7,0-101.39,.01-152.09-.01-7.85,0-13.22-4.84-13.32-11.8-.1-7.11,5.36-12.06,13.39-12.14,1.06-.01,2.13,0,3.19,0,52.96,0,105.92-.04,158.87,.09,3.73,0,5.93-.95,7.99-4.21,8.54-13.54,19.98-24.2,34.16-31.61,7.22-3.78,14.94-6.61,22.71-9.98v-4.02c0-58.42,0-116.85,0-175.27,0-10.66-4.65-15.36-15.25-15.36-49.63,0-99.26,0-148.89,0h-4.33v5c0,25.69,0,51.37,0,77.06,0,10.16-4.41,14.57-14.57,14.57-25.55,0-51.1,0-76.64,0h-4.6v3.53c0,82.38,0,164.76,0,247.14,0,9.02,4.73,13.65,13.88,13.66,68.93,.01,137.85,0,206.78,0,1.1,0,2.2-.15,3.95-.29-15.02-13.55-24.82-29.53-29.98-48.42h-5.05c-50.16,0-100.33,0-150.49,0-9.53,0-15.13-4.46-15.11-12.02,.03-7.55,5.6-11.94,15.19-11.94,49.23,0,98.46,0,147.7,0h4.35c1.04-8.22,2.01-15.85,3.04-23.96Zm94.23-47.9c-39.79-.18-72.53,31.89-72.89,71.39-.35,39.25,33,72.94,72.4,73.13,39.14,.18,72.57-32.95,72.89-72.24,.32-39.48-32.35-72.09-72.4-72.27ZM40.82,96.46h54.7V43.09c-17.79,17.36-35.94,35.06-54.7,53.37Z"></path><path class="cls-4" d="M156.14,168.54c31.4,0,62.81-.03,94.21,.02,9.37,.01,15.35,7.7,12.43,15.86-1.74,4.86-5.36,7.45-10.43,8.01-1.32,.15-2.66,.07-3.99,.07-61.74,0-123.48,0-185.22,0-9.58,0-15.15-4.41-15.15-11.98,0-7.57,5.57-11.98,15.15-11.98,31,0,62.01,0,93.01,0Z"></path><path class="cls-2" d="M133.78,240.41c-24.34,0-48.67,.05-73.01-.03-9.21-.03-15.11-8.1-11.97-16.17,1.74-4.48,5.16-6.97,9.88-7.65,1.05-.15,2.12-.1,3.19-.1,48.14,0,96.28,0,144.42,0,6.84,0,11.48,2.92,13.19,8.19,2.58,7.97-3.11,15.66-11.88,15.73-15.03,.12-30.05,.03-45.08,.04-9.57,0-19.15,0-28.72,0Z"></path><path class="cls-3" d="M203.42,96.66c-15.7,0-31.4,.02-47.1,0-5.29,0-9.27-2.35-11.47-7.17-2-4.37-1.66-9,1.82-12.21,2.44-2.24,6.14-4.34,9.3-4.37,31.8-.32,63.6-.24,95.4-.15,6.91,.02,12.03,5.22,12.13,11.75,.1,6.69-5.1,12.05-12.18,12.1-15.97,.12-31.93,.04-47.9,.04Z"></path><path class="cls-6" d="M203.94,120.63c15.7,0,31.4-.09,47.1,.04,9.09,.07,14.94,8.53,11.51,16.49-2.17,5.03-6.25,7.42-11.7,7.42-13.04,.01-26.08,0-39.12,0-18.36,0-36.72,.06-55.08-.03-9.39-.04-15.41-8.4-11.91-16.5,2.25-5.2,6.49-7.45,12.1-7.44,15.7,.04,31.4,.01,47.1,.01Z"></path><path class="cls-5" d="M300.27,333.02c7.91-8.36,14.75-15.78,21.8-23,5.94-6.09,11.98-12.1,18.19-17.9,7.21-6.74,17.75-3.92,20.24,5.25,1.19,4.38,0,8.28-3.11,11.37-16.24,16.1-32.5,32.19-48.93,48.09-4.94,4.79-11.44,4.66-16.53-.09-8.36-7.8-16.57-15.76-24.65-23.85-4.97-4.98-4.97-12.01-.42-16.85,4.5-4.79,11.53-5.04,16.85-.43,2.81,2.43,5.47,5.06,8.04,7.75,2.57,2.69,4.94,5.58,8.53,9.67Z"></path></svg> </span> </div> <div class="elementor-icon-box-content"> <h3 class="elementor-icon-box-title"> <span > RDC 53 </span> </h3> <p class="elementor-icon-box-description"> The RDC 53 guideline stipulates the need to understand the consequences of degradation with a focus on impurities and stability testing to limit the risk of toxic features. Our expert <i>in silico</i> software Zeneth, is invaluable in meeting many of the requirements under RDC 53. Zeneth predicts the forced degradation pathways of organic compounds and considers the effect of different excipients and impurities within the final formulated product. In addition, Zeneth can help to determine the chemical structures of degradants detected by a mass spectrometer, or other detection methods, and to deduce the likely degradation pathways, supporting assessments for RDC 53 regulatory submission. </p> </div> </div> </div> </div> <div class="elementor-element elementor-element-9533da7 elementor-align-center elementor-widget elementor-widget-button" data-id="9533da7" data-element_type="widget" data-widget_type="button.default"> <div class="elementor-widget-container"> <div class="elementor-button-wrapper"> <a class="elementor-button elementor-button-link elementor-size-sm" href="/contact-us"> <span class="elementor-button-content-wrapper"> <span class="elementor-button-text">Get in touch</span> </span> </a> </div> </div> </div> </div> </div> </div> </section> <section class="elementor-section elementor-top-section elementor-element elementor-element-8a76951 elementor-section-boxed elementor-section-height-default 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Mirabilis is our …</p> </div> <div class="premium-blog-entry-meta"> </div> </div> </div> </div> <div class="premium-blog-post-outer-container" data-total="27"> <div class="premium-blog-post-container premium-blog-skin-cards"> <div class="premium-blog-thumb-effect-wrapper"> <div class="premium-blog-thumbnail-container premium-blog-none-effect"> <a href="https://www.lhasalimited.org/blog/eurotox-2024-advancing-toxicology-in-copenhagen/" target="_self"> <img loading="lazy" decoding="async" width="1080" height="864" src="https://www.lhasalimited.org/wp-content/uploads/2024/09/Eurotox-blog.jpg" class="attachment-full size-full wp-image-11241" alt="EUROTOX 2024: A memorable gathering in Copenhagen" srcset="https://www.lhasalimited.org/wp-content/uploads/2024/09/Eurotox-blog.jpg 1080w, https://www.lhasalimited.org/wp-content/uploads/2024/09/Eurotox-blog-300x240.jpg 300w, https://www.lhasalimited.org/wp-content/uploads/2024/09/Eurotox-blog-1024x819.jpg 1024w, https://www.lhasalimited.org/wp-content/uploads/2024/09/Eurotox-blog-768x614.jpg 768w" sizes="(max-width: 1080px) 100vw, 1080px" /> </a> </div> <div class="premium-blog-effect-container premium-blog-none-effect"> <a class="premium-blog-post-link" href="https://www.lhasalimited.org/blog/eurotox-2024-advancing-toxicology-in-copenhagen/" target="_self"><span>EUROTOX 2024: Advancing toxicology in Copenhagen</span></a> </div> </div> <div class="premium-blog-content-wrapper "> <div class="premium-blog-inner-container"> <h2 class="premium-blog-entry-title"> <a href="https://www.lhasalimited.org/blog/eurotox-2024-advancing-toxicology-in-copenhagen/" target="_self"> EUROTOX 2024: Advancing toxicology in Copenhagen </a> </h2> </div> <div class="premium-blog-content-inner-wrapper"> <p class="premium-blog-post-content">We had a fantastic time at EUROTOX 2024, held from 8 &#8211; 11th September in the picturesque city of Copenhagen, Denmark. This …</p> </div> <div class="premium-blog-entry-meta"> </div> </div> </div> </div> </div> </div> </div> <div class="elementor-element elementor-element-f7a4047 elementor-align-center elementor-widget elementor-widget-button" data-id="f7a4047" data-element_type="widget" data-widget_type="button.default"> <div class="elementor-widget-container"> <div class="elementor-button-wrapper"> <a class="elementor-button elementor-button-link elementor-size-sm" href="https://www.lhasalimited.org/blog/"> <span class="elementor-button-content-wrapper"> <span class="elementor-button-text">View all blogs</span> </span> </a> </div> </div> </div> </div> </div> </div> </section> </div> </div><!-- .entry-content .clear --> </article><!-- #post-## --> </main><!-- #main --> </div><!-- #primary --> </div> <!-- ast-container --> </div><!-- #content --> <div data-elementor-type="footer" data-elementor-id="275" class="elementor elementor-275 elementor-location-footer" 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