Nitrosamines or N-nitrosamines are formed when amines react with nitrous acid salts – so-called nitrites – under acidic conditions such as those found in the stomach. These have been classified as possible carcinogens for humans.
In the past, contamination by nitrosamines was detected in various medications. This necessitated a review of production processes to identify, exclude or minimize possible sources of contamination in raw materials, solvents (such as DMF), during chemical synthesis or even in the supply chain.