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LC-MS/MS method for the quantification of 10 nitrosamine impurities in metformin
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Complete your profile at your earliest convenience to unlock the rest of your benefits:<br> <ul> <li>relevant and personalised updates about your field</li> <li>access to White Papers/product profiles</li> <li>digital magazine subscription</li> </ul> </div> </template> </vue-registration-complete> <div class="b_article__header b_article__header--appnote "> <h1 class="b_article__headline b_article__headline--h1">LC-MS/MS method for the quantification of 10 nitrosamine impurities in metformin</h1> <div class="b_article__divider"> <figure class="b_article__figure"> <picture><source srcset="/fileadmin/_processed_/3/4/csm_ThermoFisher-logo_befeb30497.webp" media="(min-width: 1024px)" type="image/webp" /><source srcset="/fileadmin/_processed_/3/4/csm_ThermoFisher-logo_a79576af2c.png" media="(min-width: 1024px)" /><source srcset="/fileadmin/_processed_/3/4/csm_ThermoFisher-logo_b3a8c0484c.webp" media="(min-width: 1280px)" type="image/webp" /><source srcset="/fileadmin/_processed_/3/4/csm_ThermoFisher-logo_cbdba551eb.png" media="(min-width: 1280px)" /><source srcset="/fileadmin/_processed_/3/4/csm_ThermoFisher-logo_f4ff0fa436.webp" type="image/webp" /><img src="/fileadmin/_processed_/3/4/csm_ThermoFisher-logo_cea0bacac2.png" width="178" height="40" loading="lazy" alt="" /></picture> </figure> <p class="b_article__info"> contributed by <a href="/companies/thermo-fisher-scientific" target="_blank" class="b_article__infolink">Thermo Fisher Scientific</a> | <time datetime="2021-03-08"> 03/08/2021 </time> </p> </div> </div> <div class="b_main__column-content b_main__column-content--marginal"> <!--TYPO3SEARCH_begin--> <div id="bJS_article"> <h3 class="b_ceheader__header b_ceheader__header--h3">Introduction</h3><p class="b_rte__bodytext">Since 2018, multiple batches of drug products, including angiotensin receptor blockers1 (ARBs) and the histamine blocker ranitidine2 (commonly known as Zantac™), have been recalled due to the presence of nitrosamines at unacceptable amounts. Scientists at the Center for Drug Evaluation and Research (CDER) division of the U.S. Food and Drug Administration (FDA) have published multiple methods to test these products for the presence of nitrosamines, including gas chromatography-mass spectrometry (GC-MS) and liquid chromatography-MS (LC-MS) technologies. These methods are specific for detecting and quantifying up to eight different nitrosamines in these drug products, even if present at amounts well below the allowable intake level. The FDA was notified by international regulators of the presence of nitrosamines, particularly N-nitrosodimethylamine (NDMA) in metformin3, a biguanides drug product and the first-line medication for the treatment of type 2 diabetes. Using the expertise gained in detecting nitrosamines in other products (e.g., ARBs and ranitidine), the FDA developed and validated two different and complementary methods to test for multiple nitrosamines in metformin products.</p><div class="b_clearfix"></div> </div> <!--TYPO3SEARCH_end--> <div class="b_clearfix"></div> <div class="b_access b_access--blend" > <header class="b_page__header b_page__header--h2">Read the full article now</header> <p class="b_rte__bodytext">Log in or register to read this article in full and gain access to The Medicine Maker’s entire content archive. 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