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.

We offer more than 50 of nitrosamines from stock on a 5-10 g scale.

For design and a full list, you can find at MedChem Highlights section of Enamine’s
website or in the white paper attachment.