Nitrosamine Impurity Analysis-Achieving Compliance through Chromeleon CDS for GC-MS

Name: Nitrosamine Impurity Analysis-Achieving Compliance through Chromeleon CDS for GC-MS
Uploaded: 2020-05-28
Channel: Thermo Fisher Scientific
Description: The pharma industry has been impacted with several costly global recalls after Nitrosamine impurities were discovered in various drug substances such as valsartan and ranitidine by the US FDA & EMA. According to new US FDA and EMA recommendations

VideoWebinar on Demand

By Thermo Fisher Scientific On May 28, 2020

The pharma industry has been impacted with several costly global recalls after Nitrosamine impurities were discovered in various drug substances such as valsartan and ranitidine by the US FDA & EMA. According to new US FDA and EMA recommendations, manufacturers of Angiotensin-receptor blockers (ARBs) or sartans must ensure that their generic sartans should contain no quantifiable levels of nitrosamine impurities after a certain transition period.

Thermo Scientific™ Chromeleon™ 7.3 Chromatography Data System (CDS), together with our world class analytical instrumentation, offers significant productivity advances to the laboratory (up to 33%*) while enabling you to meet evolving regulatory compliance and data integrity requirements.

Speaker: Manoj M. Soman, Product Manager, Chromeleon

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