Technology Digest: Nitrosamine Impurities – From Raw Materials to Final Drug Product

Podcast | Infographic  | Download the eBook | Webinar What are nitrosamines? Nitrosamines are a class of mutagenic impurities which contain the nitroso functional group and are formed when a secondary or tertiary amine reacts with a nitrosating agent [1]. Two common nitrosamines include N-nitrosodimethylamine (NDMA) and N-nitrosodiethylamine (NDEA), which have been classified as potential human carcinogens by the International Agency for Research on Cancer [1,2]. A carcinogenic response is induced when the N-nitrosamines are activated by microsomal liver enzymes and react with DNA. Low levels of these compounds can be found in food and drinks, such as roasted meats,...