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</ul></nav></div></section> </div><div class="breadcrumb"><span class="breadcrumb-link-wrap"><a href="https://www.thermofisher.com/blog/?">Accelerating Science</a></span><span class="breadcrumb-link-wrap"><a class="breadcrumb-link" href="https://www.thermofisher.com/blog/analyteguru/"><span class="breadcrumb-link-text-wrap">AnalyteGuru</span></a><meta ></span> <span aria-label="breadcrumb separator">/</span> <span class="breadcrumb-link-wrap"><a class="breadcrumb-link" href="https://www.thermofisher.com/blog/analyteguru/pharmaceutical/"><span class="breadcrumb-link-text-wrap">Pharmaceutical</span></a><meta ></span> <span aria-label="breadcrumb separator">/</span> <span class="breadcrumb-current-title">5 Ways to Become a Nitrosamine Ninja</span></div></div></header><div class="site-inner"><div class="content-sidebar-wrap"><main class="content"><article class="post-320 post type-post status-publish format-standard has-post-thumbnail category-pharmaceutical tag-hram tag-mass-spectrometry tag-nitrosamines entry" aria-label="5 Ways to Become a Nitrosamine Ninja"><header class="entry-header"><h1 class="entry-title">5 Ways to Become a Nitrosamine Ninja</h1> <span class="post-info-author"> By <a href="https://www.thermofisher.com/blog/analyteguru/tf-author/aaron-lamb/" title="Posts by Aaron Lamb" rel="author">Aaron Lamb, </a> </span> <span class="post-info-date"> 05.03.2021 </span> </header><div class="entry-content"><div class="lia-message-body-content"> <h3 id="toc-hId--1873734968"><strong>More than just trace analysis</strong></h3> <p>For effective ultra-trace analysis of nitrosamines in pharmaceuticals you need more than Ninja Stars and Katanas! Your arsenal should include advanced weaponry, including high-resolution accurate mass (HRAM) and triple quadrupole (QQQ) mass spectrometry (MS) to slice through uncertainty. Why? As a ninja, speed and accuracy are your key strengths in guarding against false positive results in your lab.</p> <p><span class="lia-inline-image-display-wrapper lia-image-align-inline"><img decoding="async" class="lia-media-image alignright" title="0503-ninja-image-1-blog" role="button" src="https://www.thermofisher.com/blog/analyteguru/wp-content/uploads/sites/25/2023/06/5-Ways-to-Become-a-Nitrosamine-Ninja-0.jpg" alt="0503-ninja-image-1-blog" width="584" height="329" /></span>In 2018 the Federal Drug Administration (FDA) showed the presence of n-nitroso dimethylamine (NDMA) at unacceptable levels in <a href="https://www.fda.gov/drugs/drug-safety-and-availability/fda-updates-and-press-announcements-angiotensin-ii-receptor-blocker-arb-recalls-valsartan-losartan" target="_blank" rel="noopener nofollow noreferrer">Valsartan, Losartan, Irbesartan</a>, then <a href="https://www.fda.gov/news-events/press-announcements/fda-requests-removal-all-ranitidine-products-zantac-market" target="_blank" rel="noopener nofollow noreferrer">Ranitidine</a> and more recently <a href="https://www.fda.gov/drugs/drug-safety-and-availability/fda-updates-and-press-announcements-ndma-metformin" target="_blank" rel="noopener nofollow noreferrer">Metformin</a>. A transition period of <a href="https://www.ema.europa.eu/en/human-regulatory/post-authorisation/referral-procedures/nitrosamine-impurities" target="_blank" rel="noopener nofollow noreferrer">two years</a> has been granted by the regulatory authorities, including the FDA and European Medicines Agency (EMA). This was to allow pharmaceutical manufacturers to make risk assessments across their entire pharmaceutical product lines (I know! A lot of work) and then implement the relevant changes in manufacturing processes. <a href="https://www.thermofisher.com/uk/en/home/industrial/pharma-biopharma/pharmaceutical-quality-control-testing/nitrosamine-impurity-analysis.html" target="_blank" rel="nofollow noopener">FDA methods</a> exist on GC (gas chromatography) and LC (liquid chromatography) involving unit mass resolution QQQs, however unit mass resolution MS is unable to resolve certain interferences such as DMF (dimethyl formamide), a common solvent used in production that can lead to overestimation of NDMA. In fact, DMF is so closely related to NDMA that a minimum mass <a href="https://view.highspot.com/viewer/60796c56b7b7393dbbdb15be" target="_blank" rel="noopener nofollow noreferrer">resolving power of 50k is needed</a> to ensure success!</p> <p>Fear not though! <a href="https://www.thermofisher.com/uk/en/home/industrial/mass-spectrometry/liquid-chromatography-mass-spectrometry-lc-ms/lc-ms-systems/orbitrap-lc-ms.html?ce=E.21CMD.DL107.34553.01&cid=E.21CMD.DL107.34553.01&ef_id=Cj0KCQjw6-SDBhCMARIsAGbI7Ug7gy206NGCu0di07PJTwxxGGYnJibb53-O_N6Eo_XS00mGefZfE6UaAtAKEALw_wcB:G:s&s_kwcid=AL!3652!3!414526973211!e!!g!!orbitrap&gclid=Cj0KCQjw6-SDBhCMARIsAGbI7Ug7gy206NGCu0di07PJTwxxGGYnJibb53-O_N6Eo_XS00mGefZfE6UaAtAKEALw_wcB" target="_blank" rel="nofollow noopener">Orbitrap MS</a> can save the day with ultra-high mass resolution (<a href="https://www.thermofisher.com/uk/en/home/industrial/mass-spectrometry/liquid-chromatography-mass-spectrometry-lc-ms/lc-ms-systems/orbitrap-lc-ms/orbitrap-exploris-mass-spectrometers/orbitrap-exploris-480-mass-spectrometers.html" target="_blank" rel="nofollow noopener">up to 480k on Exploris platforms)</a> guarding against false positive results and with the sensitivity to easily meet the <a href="https://www.fda.gov/media/141720/download" target="_blank" rel="noopener nofollow noreferrer">FDA LOQ</a> (limit of quantification) limits of 0.03 ppm. In addition, using a complementary LC and GC HRAM for a screening and confirmatory approach can synergistically guard against false positive results, giving you ultimate confidence! The robustness of modern HRAM MS benchtop systems such as the new <a href="https://www.thermofisher.com/uk/en/home/industrial/mass-spectrometry/gas-chromatography-mass-spectrometry-gc-ms/gc-ms-systems/high-resolution-accurate-mass-gc-ms/orbitrap-exploris-gc.html" target="_blank" rel="nofollow noopener">Orbitrap™ Exploris™ GC Mass Spectrometer</a> combined with simple and familiar <a href="https://assets.thermofisher.com/TFS-Assets/CMD/brochures/sp-70763-cds-chromeleon-designed-ms-sp70763-en.pdf" target="_blank" rel="nofollow noopener">compliance-ready MS chromatography data system software</a>, and the ability to check with high selectivity and sensitivity in full scan (FS) data acquisition mode is both highly practical and desirable for trace analysis.</p> <h3 id="toc-hId--1845105817"><strong>Resolution matters – from research to QC: Want to find out more? 5 ways to become a Nitrosamine Ninja</strong></h3> <h3 id="toc-hId--1816476666"><strong>1. Download our most sensitive nitrosamines GC Exploris Orbitrap HRAM method application note</strong></h3> <p>“A validated method for the rapid determination of fifteen nitrosamines in metformin drug substance”<br />Separation of 15 nitrosamines was achieved in under 14 minutes with LOQs <2 ng/g (ppb w/w) validated to align with ICH regulatory guidelines and easily meeting FDA LOQ requirements of 30 ppb.<br /><a href="https://view.highspot.com/viewer/6074068134d6be4065e31a05" target="_blank" rel="noopener nofollow noreferrer">Download Now ></a></p> <p><img decoding="async" class="aligncenter size-full wp-image-13987" src="https://www.thermofisher.com/blog/analyteguru/wp-content/uploads/sites/25/2021/03/050321-nitrosamines-image-2.png" alt="" width="998" height="703" srcset="https://www.thermofisher.com/blog/analyteguru/wp-content/uploads/sites/25/2021/03/050321-nitrosamines-image-2.png 998w, https://www.thermofisher.com/blog/analyteguru/wp-content/uploads/sites/25/2021/03/050321-nitrosamines-image-2-300x211.png 300w, https://www.thermofisher.com/blog/analyteguru/wp-content/uploads/sites/25/2021/03/050321-nitrosamines-image-2-768x541.png 768w" sizes="(max-width: 998px) 100vw, 998px" /></p> <h3 id="toc-hId--1787847515"> </h3> <h3 id="toc-hId--1759218364"><strong>2. Download our most sensitive nitrosamines LC HRAM method application note</strong></h3> <p>“HRAM LC-MS method for the determination of nitrosamine impurities in drugs”<br />Separation of 9 nitrosamines was achieved in under 8 minutes with LOQs <17 ng/g (ppb w/w) meeting FDA LOQ requirements of 30 ppb.<br /><a href="https://view.highspot.com/viewer/607960026a3b110f89c0f839" target="_blank" rel="noopener nofollow noreferrer">Download Now ><br /></a></p> <h3 id="toc-hId--1730589213"><img loading="lazy" decoding="async" class="aligncenter size-full wp-image-13988" src="https://www.thermofisher.com/blog/analyteguru/wp-content/uploads/sites/25/2021/03/050321-hram-nitrosamine-image-3.png" alt="" width="873" height="483" srcset="https://www.thermofisher.com/blog/analyteguru/wp-content/uploads/sites/25/2021/03/050321-hram-nitrosamine-image-3.png 873w, https://www.thermofisher.com/blog/analyteguru/wp-content/uploads/sites/25/2021/03/050321-hram-nitrosamine-image-3-300x166.png 300w, https://www.thermofisher.com/blog/analyteguru/wp-content/uploads/sites/25/2021/03/050321-hram-nitrosamine-image-3-768x425.png 768w, https://www.thermofisher.com/blog/analyteguru/wp-content/uploads/sites/25/2021/03/050321-hram-nitrosamine-image-3-450x250.png 450w" sizes="(max-width: 873px) 100vw, 873px" /></h3> <h3 id="toc-hId--1701960062"> </h3> <h3 id="toc-hId--1673330911"><strong>3. Register for this HRAM nitrosamines webinar</strong></h3> <p>Overcoming the challenges of nitrosamine analysis in pharmaceuticals with HRAM<br /><a href="https://event.on24.com/eventRegistration/EventLobbyServlet?target=reg20.jsp&partnerref=SoMePres&eventid=3135151&sessionid=1&key=398C7E0E015FCFD52AB164C1C3F4A967&regTag=2336436&V2=false&sourcepage=register" target="_blank" rel="noopener nofollow noreferrer">Register for this webinar</a></p> <p><img loading="lazy" decoding="async" class="aligncenter size-full wp-image-13989" src="https://www.thermofisher.com/blog/analyteguru/wp-content/uploads/sites/25/2021/03/050321-nitrosamine-image-6.jpg" alt="" width="999" height="666" srcset="https://www.thermofisher.com/blog/analyteguru/wp-content/uploads/sites/25/2021/03/050321-nitrosamine-image-6.jpg 999w, https://www.thermofisher.com/blog/analyteguru/wp-content/uploads/sites/25/2021/03/050321-nitrosamine-image-6-300x200.jpg 300w, https://www.thermofisher.com/blog/analyteguru/wp-content/uploads/sites/25/2021/03/050321-nitrosamine-image-6-768x512.jpg 768w, https://www.thermofisher.com/blog/analyteguru/wp-content/uploads/sites/25/2021/03/050321-nitrosamine-image-6-96x65.jpg 96w" sizes="(max-width: 999px) 100vw, 999px" /></p> <h3 id="toc-hId--1644701760"> </h3> <h3 id="toc-hId-2123961174"><strong>4. Visit this nitrosamine website</strong></h3> <p>Keep up to date with current and future technology innovations by bookmarking this webpage:<br /><a href="https://www.thermofisher.com/uk/en/home/industrial/pharma-biopharma/pharmaceutical-quality-control-testing/nitrosamine-impurity-analysis.html" target="_blank" rel="nofollow noopener">ThermofisherScientific/Nitrosamines</a></p> <p><img loading="lazy" decoding="async" class="aligncenter size-full wp-image-13990" src="https://www.thermofisher.com/blog/analyteguru/wp-content/uploads/sites/25/2021/03/050321-nitrosamine-image-4.png" alt="" width="999" height="523" srcset="https://www.thermofisher.com/blog/analyteguru/wp-content/uploads/sites/25/2021/03/050321-nitrosamine-image-4.png 999w, https://www.thermofisher.com/blog/analyteguru/wp-content/uploads/sites/25/2021/03/050321-nitrosamine-image-4-300x157.png 300w, https://www.thermofisher.com/blog/analyteguru/wp-content/uploads/sites/25/2021/03/050321-nitrosamine-image-4-768x402.png 768w" sizes="(max-width: 999px) 100vw, 999px" /></p> <h3 id="toc-hId--2142376971"> </h3> <h3 id="toc-hId--2113747820"><strong>5. Learn more about Chromeleon CDS</strong></h3> <p>Chromeleon delivers everything that IT system administrators need AND makes it easier than ever to meet evolving 21 CFR Part 11 regulatory compliance and data integrity requirements.</p> <p><a href="https://cen.acs.org/articles/94/i22/Mass-spec-weighs-protein-therapeutics.html?h=418213537" target="_blank" rel="noopener nofollow noreferrer">Read article ></a></p> <p><img loading="lazy" decoding="async" class="aligncenter size-full wp-image-13991" src="https://www.thermofisher.com/blog/analyteguru/wp-content/uploads/sites/25/2021/03/050321-built-for-the-lab-image-5.png" alt="" width="997" height="213" srcset="https://www.thermofisher.com/blog/analyteguru/wp-content/uploads/sites/25/2021/03/050321-built-for-the-lab-image-5.png 997w, https://www.thermofisher.com/blog/analyteguru/wp-content/uploads/sites/25/2021/03/050321-built-for-the-lab-image-5-300x64.png 300w, https://www.thermofisher.com/blog/analyteguru/wp-content/uploads/sites/25/2021/03/050321-built-for-the-lab-image-5-768x164.png 768w" sizes="(max-width: 997px) 100vw, 997px" /></p> </div> <p><strong>Related blog posts</strong></p> <p><a href="https://www.thermofisher.com/blog/analyteguru/every-tool-you-will-ever-need-for-nitrosamine-impurity-analysis/" target="_blank" rel="noreferrer noopener">Nitrosamine Impurity Analysis: Every Tool You Will Ever Need</a></p> <p><a href="https://www.thermofisher.com/blog/analyteguru/overcoming-the-challenges-of-nitrosamine-analysis/" target="_blank" rel="noreferrer noopener">Overcoming the Challenges of Nitrosamine Analysis</a></p> <p><a href="https://www.thermofisher.com/blog/analyteguru/what-are-nitrosamines-and-why-should-i-care/" target="_blank" rel="noreferrer noopener">What are Nitrosamines and Why Should I Care?</a></p> </div></article><section class="author-box"><h4 class="author-box-title">Aaron Lamb</h4><div class="author-box-content" itemprop="description"></div></section><div class="adjacent-entry-pagination pagination"><div class="pagination-previous alignleft"><i class="fa fa-icon fa-chevron-left"></i> <a href="https://www.thermofisher.com/blog/analyteguru/the-missing-link/" rel="prev">The Missing Link in Your Metabolomics Analysis</a></div><div class="pagination-next alignright"><a href="https://www.thermofisher.com/blog/analyteguru/is-automating-sample-preparation-just-about-convenience/" rel="next">Is Automating Sample Preparation Just About Convenience?</a> <i class="fa fa-icon fa-chevron-right"></i></div></div></main></div></div><footer class="site-footer"><div class="wrap"><div class="creds"><p class="footer-links"><a href="https://corporate.thermofisher.com/en/footer/privacy-statement.html" target="_blank" rel="noopener noreferrer">Privacy Statement</a><a href="https://corporate.thermofisher.com/en/footer/terms-and-conditions.html" target="_blank" rel="noopener noreferrer">Terms & Conditions</a><a href="/blog/locations/">Locations</a><a href="/blog/sitemap/">Sitemap</a></p><p>© 2024 <a href="https://www.thermofisher.com">Thermo Fisher Scientific</a>. 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