Nitrosamines Analysis Case Study

N-nitrosamines are probable human carcinogens which must be measured and determined to not exceed very low levels. Starting in 2018 after a series of events, a greater regulatory focus was put on N-nitrosamine contamination. In this case study, PPD® Laboratories GMP lab shares insight on how they completed method development, validation and testing to screen and quantitate NDMA in a drug product for a large pharmaceutical customer.