Nitrosamines
- Nitrosamines, or more correctly N-nitrosamines, refer to any molecule containing the nitroso functional group. These molecules are of concern because nitrosamine impurities are probable human carcinogens.
- Formation of nitrosamines is possible in the presence of secondary, tertiary, or quaternary amines22 and nitrite salts23 under acidic reaction conditions. Under these conditions, nitrite salts may form nitrous acid, which can react with an amine to form a nitrosamine. There is a greater risk of nitrosamine formation if nitrous acid is used to quench residual azide (a reagent commonly used in tetrazole ring formation or introduction of azide functional group into a molecule) in the presence of precursor amines.
- QbD has analysed nitrosamines in APIs, Intermediates, finished products, excipients, recovered solvents, water.
