Analytical Solutions for Nitrosamines in Response to USP 1469

Join us to learn about 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.

We will host a Q&A session after the presentation to address any questions or comments.

Presenter: Mridul Mandal, Ph.D. (Marketing Manager, Shimadzu Scientific Instruments)

Mridul Mandal, Ph.D. is currently working as a marketing manager -pharma/biopharma at Shimadzu Scientific Instruments. Before entering this position, he worked as an analytical researcher in academia and biopharmaCRO companies for over 12 years.

Presenter: Brian Domanski (Strategic Collaboration Scientist, Shimadzu Scientific Instruments)

Brian has over 10 years working to provide LC and SFC solutions for Pharma, as well as experience with a wide range of chromatography techniques including RP, NP, HILIC, IEX, SEC/GPC, and IC. His focus also includes scalable Informatics and Data Integrity solutions.