Nitrosamine impurities in pharmaceuticals are a class of potentially carcinogenic compounds and have led to drug recalls, increased regulatory scrutiny, and risks to patient safety. Detecting these ultra-trace impurities requires highly sensitive analytical techniques that meet stringent global standards. Highly sensitive and robust liquid chromatography tandem mass spectrometry and optimized methods provide accurate, reliable nitrosamine quantitation, empowering researchers to ensure drug safety and compliance with evolving regulations.
Download the full compendium to learn:
- Nitrosamines in monoclonal antibodies (mAbs): How to process and quantify nitrosamines in mAb formulations
- Various types of nitrosamines: Techniques for accurately quantifying common nitrosamines and nitrosamine drug substance-related impurities (NDSRIs)
- Additives that can create nitrosamines: How to identify ingredients that may cause nitrosamines to form during production
