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N-Nitrosamines

In 2018, nitrosamine impurities became a focus for authorities, when a recall of angiotensin II receptor blocker (ARB) medicines, known as “sartans”, was announced. In bioactive compounds, a toxic impurity, N-nitrosodimethylamine (NDMA), was found. Since then, more cases of drug product batches contaminated with nitrosamines came to be known (Ranitidine, Nizatidine and Metformin). In 2020, FDA announced the availability of a guidance for industry, entitled “Control of N-Nitrosamine Impurities in Human Drugs.” In this context, Enamine offers a library of various nitrosamines for investigation.

Chemical structures of 7 potential nitrosamine impurities in APIs and drug products identified by FDA in 2020:

Case studies

Representative reaction to form nitrosamines:

  • Nitrosamine compounds can form by a nitrosating reaction between amines and nitrous acid.
  • Nitrosamine compounds are potent genotoxic agents in several animal species and some are classified as probable or possible human carcinogens.

We offer

More than 50 of nitrosamines from stock on a 5-10 g scale.

MedChem Highlights

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