Analytical Solutions for Nitrosamines in Response to USP <1469>

This webinar examines Shimadzu’s comprehensive solutions for the four Procedures utilizing HR-LCMS, HS-GC-MS/MS, LC-MS/MS, and DI-GC-MS/MS as outlined in USP General Chapter 1469 for Nitrosamine impurities analysis.

These molecules, identified as potentially mutagenic by the U.S. FDA and the International Conference on Harmonization (ICH), have been the subject of industry concern since mid-2018. NDMA and other nitrosamine impurities have been detected in drug substances ranging from angiotensin II receptor blockers (ARBs) to over-the-counter proton pump inhibitors, representing a large potential for public exposure. Further studies have confirmed that API synthetic processes, solvents, storage conditions, and even interactions with packaging can contribute to the formation of nitrosamines. However, analyzing nitrosamine impurities at trace levels is challenging due to solubility issues, thermal stability, and matrix effects requiring sophisticated and sensitive analytical techniques. In this webinar we will show how Shimadzu’s highly sensitive ultra-fast mass spectrometry (UFMS) technologies powered by analytical intelligence offer solutions for quantification of trace levels of nitrosamine impurities from various drug substances and drug products.