Analysis of Genotoxic Nitrosamines in Losartan
The US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) continue to closely monitor nitrosamine levels in pharmaceutical products since the initial discovery of N-nitrosodimethylamine (NDMA) in valsartan in 2018 prompted recalls of the drug. These recalls highlight the ongoing need for sensitive, selective methods for the analysis of multiple nitrosamines in pharmaceutical products prone to contamination by these potentially carcinogenic compounds.
Download this app note to discover a system that:
- Demonstrates good chromatographic separation of nitrosamine compounds
- Provides enhanced sensitivity
- Is fully compliant with 21 CFR Part 11