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class="content"><article class="post-6556 post type-post status-publish format-standard has-post-thumbnail category-pharmaceutical tag-nitrosamines tag-webinar entry" aria-label="Webinar on Nitrosamine Exchange a USP s Knowledge Community for All Things Nitrosamine"><header class="entry-header"><h1 class="entry-title">Webinar on Nitrosamine Exchange a USP s Knowledge Community for All Things Nitrosamine</h1> <span class="post-info-author"> By <a href="https://www.thermofisher.com/blog/analyteguru/tf-author/analyteguru-staff/" title="Posts by AnalyteGuru Staff" rel="author">AnalyteGuru Staff, </a> </span> <span class="post-info-date"> 05.16.2022 </span> </header><div class="entry-content"><div class="lia-message-body-content"> <p><span class="lia-inline-image-display-wrapper lia-image-align-center" style="width: 800px"><img decoding="async" class="wp-image-6558 size-full aligncenter" src="https://www.thermofisher.com/blog/analyteguru/wp-content/uploads/sites/25/2023/06/15757-og.jpg" alt="" width="800" height="509" srcset="https://www.thermofisher.com/blog/analyteguru/wp-content/uploads/sites/25/2023/06/15757-og.jpg 800w, https://www.thermofisher.com/blog/analyteguru/wp-content/uploads/sites/25/2023/06/15757-og-300x191.jpg 300w, https://www.thermofisher.com/blog/analyteguru/wp-content/uploads/sites/25/2023/06/15757-og-768x489.jpg 768w" sizes="(max-width: 800px) 100vw, 800px" /></span></p> <p>AnalyteGuru continues its <a href="https://www.analyteguru.com/t5/Blog/Don-t-Miss-AnalyteGuru-s-Networking-in-Science-Webinar-Series-in/ba-p/15587" target="_blank" rel="noopener">Networking in Science webinar series</a> with <a href="https://www.linkedin.com/in/naiffer/" target="_blank" rel="noopener nofollow noreferrer">Naiffer Romero</a>, Senior Scientific Affairs Manager, MSc, MPH, United States Pharmacopeia (USP), on May 24 at 10 a.m. CDT. In this webinar, Romero will share how USP responded to the nitrosamine impurities crisis not only with a proposed general chapter on nitrosamine impurities but also non-compendial resources that provides a risk assessment strategy.</p> <p><a href="https://event.on24.com/wcc/r/3731822/88643D75C6C9527A76DDA0E7F79FC7A7?=cidE.22CMD.PB105.07801.01" target="_blank" rel="noopener nofollow noreferrer">Click here to register now</a></p> <h2 id="toc-hId--1333189995">Nitrosamine Impurity Analysis Overview</h2> <h3 id="toc-hId-2041826519"></h3> <h3 id="toc-hId--1365637096">What are nitrosamines?</h3> <p>Nitrosamines, or more correctly N-nitrosamines, refer to any molecules containing the nitroso functional group. These molecules are of concern because nitrosamine impurities are probable human carcinogens.</p> <h3 id="toc-hId--478133415">Why is nitrosamine impurity analysis in drugs important?</h3> <p>In July 2018, elevated levels of nitrosamines were detected and reported in certain pharmaceuticals and led to the recall of many affected drug products. Such recalls are undesirable to pharmaceutical companies, because they can lead to extra costs, revenue loss and impact the manufacturer’s reputation.</p> <p>The unexpected finding of nitrosamine impurities in drugs such as angiotensin II receptor blockers (ARBs), ranitidine, nizatidine and metformin, has made clear the need for a risk assessment strategy for potential nitrosamines in any pharmaceutical product at risk of containing their presence. Stringent regulatory guidance is not only helping to make drugs safer, but through method requirements are helping laboratories to identify the appropriate tools needed for accurate and confident analysis.</p> <p>Looking for additional information on nitrosamine impurity analysis? Download our <a href="https://www.thermofisher.com/us/en/home/global/forms/industrial/nitrosamine-impurity-analysis-drugs-important.html" target="_blank" rel="nofollow noopener">Nitrosamine Toolkit here</a>.</p> <p>Additionally, if you are looking for applications, solutions or products related to nitrosamine impurity analysis, explore our <a href="https://www.thermofisher.com/us/en/home/industrial/pharma-biopharma/pharmaceutical-quality-control-testing/nitrosamine-impurity-analysis.html#menu5" target="_blank" rel="nofollow noopener">Nitrosamine Impurity Analysis webpage</a>.</p> <h3 id="toc-hId-409370266">The nitrosamine impurities crisis</h3> <p>The nitrosamine impurities crisis prompted regulators around the world to increase their scrutiny of drug manufacturing processes even further. In the future, this greater scrutiny may lead to the discovery of nitrosamine impurities in other medicines. For this reason, manufacturers need to understand which medicines are likely to form nitrosamines, how and at what levels nitrosamine impurities are forming, and how to control nitrosamines.</p> <h3 id="toc-hId-1296873947">United States Pharmacopeia’s (USP) response to the nitrosamine crisis</h3> <p>During this webinar, Romero will explore how USP responded to the nitrosamine impurities crisis not only with a proposed general chapter on nitrosamine impurities but also non-compendial resources and tools that provides a risk assessment strategy, methods for detecting and measuring nitrosamine impurities. In that effort, USP built a knowledge community dedicated to all things nitrosamines.</p> <h3 id="toc-hId--2110589668">What you can learn from this webinar</h3> <ul> <li>How and at what levels nitrosamine impurities are forming, and ways to control them</li> <li>The importance of shared community in overcoming the challenges with nitrosamine analysis</li> <li>Tools that provide a risk assessment strategy, methods for detecting and measuring nitrosamine impurities in pharmaceutical APIs (active pharmaceutical ingredients) and drug products</li> </ul> <p>Do not miss this webinar. <a href="https://event.on24.com/wcc/r/3731822/88643D75C6C9527A76DDA0E7F79FC7A7?=cidE.22CMD.PB105.07801.01" target="_blank" rel="noopener nofollow noreferrer">Click here to register now. </a></p> <p>Do you have a question for one of our nitrosamine impurity analysis experts now? Click here to submit your question.</p> <p><a href="https://www.thermofisher.com/us/en/home/industrial/pharma-biopharma/pharmaceutical-quality-control-testing/nitrosamine-impurity-analysis.html#menu6" target="_blank" rel="nofollow noopener">Speak to a specialist now</a></p> <h3 id="toc-hId--1223085987"><strong>Meet the presenter</strong></h3> <p><img decoding="async" class="size-medium wp-image-12338 alignleft" src="https://www.thermofisher.com/blog/analyteguru/wp-content/uploads/sites/25/2023/06/Naiffer-Romero-214x300.jpg" alt="" width="214" height="300" srcset="https://www.thermofisher.com/blog/analyteguru/wp-content/uploads/sites/25/2023/06/Naiffer-Romero-214x300.jpg 214w, https://www.thermofisher.com/blog/analyteguru/wp-content/uploads/sites/25/2023/06/Naiffer-Romero.jpg 485w" sizes="(max-width: 214px) 100vw, 214px" /></p> <p><span style="color: #ff0000"><strong>Naiffer Romero</strong></span><br /> <span style="color: #ff0000">Senior Scientific Affairs Manager, MSc, MPH</span><br /> <span style="color: #ff0000">United States Pharmacopeia (USP)</span></p> <p>Naiffer Romero has more than 18 years of pharmaceutical industry experience. In his 10-year tenure with USP, he has had a variety of roles.</p> <p>Most recently, Romero joined USP’s Scientific Affairs performance cell where he leads scientific outreach and engagement for the LATAM & US region on key national health priority topics. His combined pharmaceutical expertise includes analytical development, salt and polymorph selection, development of dissolution methods, IVIVC modeling, and impurity analytical strategy.</p> <p>Romero also served as member of USP’s Nitrosamine Steering Committee and community host to “‘Nitrosamine Exchange,“ a knowledge community in all-things nitrosamine. Additionally, he also liaises technical discussions on pharmacopeial collaboration, including International meeting of World Pharmacopeias (part of WHO).</p> <p><a href="https://www.thermofisher.com/us/en/home/global/forms/industrial/biopharmaceutical-resources-promotions-information-request.html" target="_blank" rel="nofollow noopener">Sign up to receive updates</a> and information about future events.</p> </div> </div></article><section class="author-box"><h4 class="author-box-title">AnalyteGuru Staff</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/tips-to-prolong-the-lifetime-of-your-hplc-column/" rel="prev">Tips to Prolong the Lifetime of Your HPLC Column</a></div><div class="pagination-next alignright"><a href="https://www.thermofisher.com/blog/analyteguru/the-journey-forward-from-csi-to-cds-a-key-focus-on-quality-and/" rel="next">Quality in the Analytical Lab: Why Your Chromatography Data System Matters</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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