NDSRI risk assessment and trace-level analysis of N-nitrosamines

Following heightened awareness of risks posed by potent genotoxic nitrosamine contaminants in pharmaceuticals and several high-profile drug recalls, regulatory agencies, including the FDA and EMA, have issued strict guidelines to protect public health.

Explore a case study where LGC collaborated with equipment manufacturer Waters to develop a UPLC/MS/MS method for quantifying trace levels of the example NDSRI contaminant N-nitroso-sertraline in sertraline drug substance and drug product, using Waters mass spectrometry equipment with LGC reference standards.