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content="https://nitrosamines.usp.org/uploads/db7259/original/1X/245b8254540e755a018d20f2ffa64946d05afb63.svg" /> <meta property="og:url" content="https://nitrosamines.usp.org/categories" /> <meta name="twitter:url" content="https://nitrosamines.usp.org/categories" /> <meta property="og:title" content="Nitrosamines Exchange" /> <meta name="twitter:title" content="Nitrosamines Exchange" /> <meta property="og:description" content="Learn, share and discuss All-things Nitrosamines" /> <meta name="twitter:description" content="Learn, share and discuss All-things Nitrosamines" /> </head> <body class="crawler browser-update"> <header> <a href="/"> Nitrosamines Exchange </a> </header> <div id="main-outlet" class="wrap" role="main"> <div itemscope itemtype='http://schema.org/ItemList'> <meta itemprop='itemListOrder' content='http://schema.org/ItemListOrderDescending'> <table class='category-list'> <thead> <tr> <th class='category'>Category</th> <th class='topics'>Topics</th> </tr> </thead> <tbody> <tr> <td class='category' style='border-color: #808281;'> <div itemprop='itemListElement' itemscope itemtype='http://schema.org/ListItem'> <meta itemprop='position' content='0'> <meta itemprop='url' content='/c/site-feedback/2'> <h3> <a href='/c/site-feedback/2'> <span itemprop='name'>About Nitrosamines Exchange</span> </a> </h3> <div itemprop='description'>Learn about this community, and start by introducing yourself to everybody.</div> </div> </td> <td class='topics'> <div title='16 Topics'>16</div> </td> </tr> <tr> <td class='category' style='border-color: #808281;'> <div itemprop='itemListElement' itemscope itemtype='http://schema.org/ListItem'> <meta itemprop='position' content='1'> <meta itemprop='url' content='/c/how-to/22'> <h3> <a href='/c/how-to/22'> <span itemprop='name'>How-To</span> </a> </h3> <div itemprop='description'>Browse our directory. Learn how-to: post, ask questions, reply, @ tag</div> </div> </td> <td class='topics'> <div title='10 Topics'>10</div> </td> </tr> <tr> <td class='category' style='border-color: #3AB54A;'> <div itemprop='itemListElement' itemscope itemtype='http://schema.org/ListItem'> <meta itemprop='position' content='2'> <meta itemprop='url' content='/c/analytical-hub/26'> <h3> <a href='/c/analytical-hub/26'> <span itemprop='name'>Analytical Methods Hub</span> </a> </h3> <div itemprop='description'>Nitrosamines Impurities Analytical Methods Repository</div> </div> </td> <td class='topics'> <div title='4 Topics'>4</div> </td> </tr> <tr> <td class='category' style='border-color: #0E76BD;'> <div itemprop='itemListElement' itemscope itemtype='http://schema.org/ListItem'> <meta itemprop='position' content='3'> <meta itemprop='url' content='/c/nitrosamines-faqs/21'> <h3> <a href='/c/nitrosamines-faqs/21'> <span itemprop='name'>Nitrosamines FAQs</span> </a> </h3> <div itemprop='description'>Category dedicated to frequent ask questions curated by our Nitrosamine Exchange ambassador members.</div> </div> </td> <td class='topics'> <div title='5 Topics'>5</div> </td> </tr> <tr> <td class='category' style='border-color: #0088CC;'> <div itemprop='itemListElement' itemscope itemtype='http://schema.org/ListItem'> <meta itemprop='position' content='4'> <meta itemprop='url' content='/c/events/19'> <h3> <a href='/c/events/19'> <span itemprop='name'>Events / Workshops / Webinars</span> </a> </h3> <div itemprop='description'>Access past or future events on Nitrosamine. Feel free to post links that will be helpful to the community.</div> </div> </td> <td class='topics'> <div title='136 Topics'>136</div> </td> </tr> <tr> <td class='category' style='border-color: #0088CC;'> <div itemprop='itemListElement' itemscope itemtype='http://schema.org/ListItem'> <meta itemprop='position' content='5'> <meta itemprop='url' content='/c/impurities/7'> <h3> <a href='/c/impurities/7'> <span itemprop='name'>N-nitrosamines Chemistry</span> </a> </h3> <div itemprop='description'><em><strong>Discuss about N-nitrosamines chemistry.</strong></em><br> Nitrosamines can be form form amines and nitrosating agents under certain reactions conditions.</div> </div> </td> <td class='topics'> <div title='51 Topics'>51</div> </td> </tr> <tr> <td class='category' style='border-color: #0088CC;'> <div itemprop='itemListElement' itemscope itemtype='http://schema.org/ListItem'> <meta itemprop='position' content='6'> <meta itemprop='url' content='/c/limits/8'> <h3> <a href='/c/limits/8'> <span itemprop='name'>Limits of Nitrosamines</span> </a> </h3> <div itemprop='description'><em><strong>Discuss about N-nitrosamines Limits</strong></em><br> Having identified risk and sources of nitrosamines, Regulators have established ‘Acceptable Intake Limits’ for manufacturers to comply as part of their overall recommendations.</div> </div> </td> <td class='topics'> <div title='211 Topics'>211</div> </td> </tr> <tr> <td class='category' style='border-color: #0088CC;'> <div itemprop='itemListElement' itemscope itemtype='http://schema.org/ListItem'> <meta itemprop='position' content='7'> <meta itemprop='url' content='/c/rootcauses/9'> <h3> <a href='/c/rootcauses/9'> <span itemprop='name'>Root Causes</span> </a> </h3> <div itemprop='description'><em><strong>N-Nitrosamine sources:</strong></em><br> APIs, Excipients, Solvent/Water, Processes, Storage, Packaging,</div> </div> </td> <td class='topics'> <div title='24 Topics'>24</div> </td> </tr> <tr> <td class='category' style='border-color: #0088CC;'> <div itemprop='itemListElement' itemscope itemtype='http://schema.org/ListItem'> <meta itemprop='position' content='8'> <meta itemprop='url' content='/c/riskmitigation/16'> <h3> <a href='/c/riskmitigation/16'> <span itemprop='name'>Risk Assessment Strategy / Tools &amp; Technology</span> </a> </h3> <div itemprop='description'><em><strong>Discuss about Risk Assessment Strategies and Tools.</strong></em><br> A risk assessment should be conducted to determine the materials that contribute to the potential for inclusion of Nitrosamines in the drug product. All potential sources for the introduction should be consider in the risk assessment.</div> </div> </td> <td class='topics'> <div title='82 Topics'>82</div> </td> </tr> <tr> <td class='category' style='border-color: #0088CC;'> <div itemprop='itemListElement' itemscope itemtype='http://schema.org/ListItem'> <meta itemprop='position' content='9'> <meta itemprop='url' content='/c/confirmatory-testing/23'> <h3> <a href='/c/confirmatory-testing/23'> <span itemprop='name'>Confirmatory Testing &amp; Analytical Challenges</span> </a> </h3> <div itemprop='description'>The development of analytical methodology for potential genotoxic impurities (GTIs) assessment can be time consuming and laborious. While there are several approaches to method development, having a discussion forum to discuss challenges and best practices can help streamline the evaluations. This ‘Confirmatory Testing’ category provides a forum for: 1) Asking lots of questions; 2) Share your work, 3) Give plenty of feedback.</div> </div> </td> <td class='topics'> <div title='100 Topics'>100</div> </td> </tr> <tr> <td class='category' style='border-color: #0088CC;'> <div itemprop='itemListElement' itemscope itemtype='http://schema.org/ListItem'> <meta itemprop='position' content='10'> <meta itemprop='url' content='/c/inthenews/17'> <h3> <a href='/c/inthenews/17'> <span itemprop='name'>Nitrosamines in the News</span> </a> </h3> <div itemprop='description'></div> </div> </td> <td class='topics'> <div title='85 Topics'>85</div> </td> </tr> <tr> <td class='category' style='border-color: #0088CC;'> <div itemprop='itemListElement' itemscope itemtype='http://schema.org/ListItem'> <meta itemprop='position' content='11'> <meta itemprop='url' content='/c/new-scientific-knowledge-development/18'> <h3> <a href='/c/new-scientific-knowledge-development/18'> <span itemprop='name'>New Scientific Knowledge &amp; Development</span> </a> </h3> <div itemprop='description'>Discuss in-depth emergence of new scientific evidence around nitrosamines, risk factors and root cause.</div> </div> </td> <td class='topics'> <div title='126 Topics'>126</div> </td> </tr> <tr> <td class='category' style='border-color: #0088CC;'> <div itemprop='itemListElement' itemscope itemtype='http://schema.org/ListItem'> <meta itemprop='position' content='12'> <meta itemprop='url' content='/c/guidance-documents-resources/20'> <h3> <a href='/c/guidance-documents-resources/20'> <span itemprop='name'>Guidance, Documents, Resources</span> </a> </h3> <div itemprop='description'><em><strong>Access published information, guidelines, and recommendations</strong></em></div> </div> </td> <td class='topics'> <div title='174 Topics'>174</div> </td> </tr> <tr> <td class='category' style='border-color: #F1592A;'> <div itemprop='itemListElement' itemscope itemtype='http://schema.org/ListItem'> <meta itemprop='position' content='13'> <meta itemprop='url' content='/c/regulatory-intelligence/27'> <h3> <a href='/c/regulatory-intelligence/27'> <span itemprop='name'>Regulatory Intelligence</span> </a> </h3> <div itemprop='description'>International Government and Regulatory Affairs<br> Space dedicated to sharing recent regulatory updates directly on Nitrosamines Impurities</div> </div> </td> <td class='topics'> <div title='6 Topics'>6</div> </td> </tr> </tbody> </table> </div> </div> <footer class="container wrap"> <nav class='crawler-nav'> <ul> <li itemscope itemtype='http://schema.org/SiteNavigationElement'> <span itemprop='name'> <a href='/' itemprop="url">Home </a> </span> </li> <li itemscope itemtype='http://schema.org/SiteNavigationElement'> <span itemprop='name'> <a href='/categories' itemprop="url">Categories </a> </span> </li> <li itemscope itemtype='http://schema.org/SiteNavigationElement'> <span itemprop='name'> <a href='/guidelines' itemprop="url">Guidelines </a> </span> </li> <li itemscope itemtype='http://schema.org/SiteNavigationElement'> <span itemprop='name'> <a href='/tos' itemprop="url">Terms of Service </a> </span> </li> <li itemscope itemtype='http://schema.org/SiteNavigationElement'> <span itemprop='name'> <a href='/privacy' itemprop="url">Privacy Policy </a> </span> </li> </ul> </nav> <p class='powered-by-link'>Powered by <a href="https://www.discourse.org">Discourse</a>, best viewed with JavaScript enabled</p> </footer> <!-- Google Tag Manager (noscript) --> <noscript><iframe src="https://www.googletagmanager.com/ns.html?id=GTM-M9F65K3" height="0" width="0" style="display:none;visibility:hidden"></iframe></noscript> <!-- End Google Tag Manager (noscript) --> <div class="buorg"><div>Unfortunately, <a href="https://www.discourse.org/faq/#browser">your browser is unsupported</a>. 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