Nitrosamines Mixture Standard Solutions

Nitrosamines are a group of compounds with a structure in which a hydrogen bound to the amine nitrogen is replaced by a nitroso group, and some of these compounds are known to be carcinogenic.
Nitrosamines are also formed as a reaction product of secondary amines and nitrous acid, so they can be detected as impurities in the manufacturing process of pharmaceuticals and are controlled under ICH M7 (Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risk).
In recent years, there have been cases of nitrosamines being detected in sartan and latinidine drugs, resulting in recalls. In response, in September 2019, the EMA (European Medicines Agency) requested the marketing authorization holders to evaluate the risk of the presence of nitrosamine impurities in their drugs and take appropriate risk mitigation measures.

We offer a wide range of analytical standards and mixture standard solutions for nitrosamines of various structures*^{1, 2}.

This page introduces the mixture standard solutions for nitrosamines regulated by USP, Ph. Eur. and EMA.