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.
These necessarily stringent regulations place a significant burden on manufacturers to maintain advanced equipment, analytical methods, and expertise to ensure sensitive and robust detection of nitrosamines, including Nitrosamine Drug Substance-related Impurities (NDSRIs) in pharmaceuticals.
This poster presents a case study in which LGC collaborated with equipment manufacturer Waters to develop a reliable 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.
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NDSRI Risk Assessment and Trace-Level Analysis of N-Nitrosamines