Blog

Nitrosamine Impurities

• By System Administrator
• 02/09/2025
• 0 comments

Nitrosamine Impurities in Pharmaceuticals: Ensuring Safety and Compliance Nitrosamine compounds are potent genotoxic agents [1], have become a critical concern in pharmaceutical products. Their detection as impurities was first reported in 2018, with N-nitrosodimethylamine (NDMA) found in valsartan, an angiotensin II receptor blocker (ARB). Since then, regulatory agencies such as the US FDA, EMA, and Health Canada have mandated strict control measures to ensure patient safety. Formation of nitrosamines is possible in the presence of secondary amines, tertiary and quaternary ami..