The nitrosamine challenge We have developed advanced analytical solutions to identify and quantify all nitrosamine contaminants, including challenging Nitrosamine Drug Substance-Related Impurities (NDSRIs). This class of contaminants – unique to each drug substance – requires specialized expertise to develop tailored analytical methods for effective monitoring.
The U.S. Food and Drug Administration emphasizes the importance of control strategies to prevent or limit nitrosamine impurities in pharmaceutical products, including – risk assessment, testing, control measures, and where necessary, process improvement. U.S. Food and Drug Administration, 2023
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