Nitrosamine Testing Services
Summary: Nitrosamine impurities are a class of compounds considered probable human carcinogens. These compounds are subject to various FDA, EMA, and other regulatory requirements typically requiring levels below an allowable intake limit between 26.5 and 1500 ng/day depending on the specific nitrosamine. Catalent’s Organic Spectroscopy group has several years of experience with quantitation of both the common solvent related nitrosamines and developing test methods for the Nitrosamine Drug Substance Related Impurities (NDSRIs). Download this fact sheet to learn more about our experience and expertise with nitrosamines testing.