Application Note: Nitrosamine impurities application guide
11 February 2021

Mutagenic impurities in APIs and drug products pose a significant risk to health and safety – even in small quantities – and thus are a major concern for drug manufacturers. In this application guide, Agilent Technologies provides an overview of recent regulatory action regarding nitrosamine impurities and outlines a complete workflow solution for the accurate detection and quantification of mutagenic impurities in APIs and drug products.