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