Nitrosamine Impurity & Control Testing

Nitrosamines and nitrosamine drug substance-related impurities (NDSRIs) in active pharmaceutical ingredients (APIs) and drug products present serious risks to patient health. To address these concerns, regulatory agencies have introduced stringent guidelines, including new FDA requirements setting strict acceptable intake (AI) limits for NDSRIs, effective August 1, 2025. Manufacturers must ensure compliance with these limits to guarantee product safety.

SK pharmteco’s team of seasoned scientists offers extensive expertise in nitrosamine and genotoxic impurity assessments. With robust analytical solutions, we provide reliable testing services for the identification and quantification of impurities, ensuring product quality and maintaining patient confidence.