Nitrosoamine Impurities: Current Status, Challenges and Future Perspectives
N-nitrosamine (NA) impurities have emerged as a critical safety concern in pharmaceutical manufacturing since the 2018 discovery of N-nitrosodimethylamine (NDMA) contamination in valsartan, which triggered global recalls and revealed similar issues in metformin, ranitidine, and rifampicin. Classified as Class 1 mutagen...