We have expertise in the synthesis of various rare and complex impurities of nitrosamine Or N-nitroso amine impurities.

The nitrosamine impurities are probable human carcinogens. Therefore, to avoid the presence of nitrosamine impurities from human medicines and APIs.

The formation of nitrosamines is generally only possible when secondary or tertiary amines react with nitrous acid. Nitrous acid itself is unstable but can be formed in situ from nitrites (NO2) under acid conditions.

In the case of the Sartan APIs compounds, most contain a tetrazole ring and the formation of this tetrazole ring employs the use of sodium nitrite the solvents employed either were amines, or contained traces of amines, and this likely afforded the observed NDMA and NDEA.

Due to their structural similarity, NMEA (N-nitroso methyl amine), NEIPA (N-ethyl-N-nitroso-2-pro-panamine), NDIPA (N-nitroso-N-Propyl-1-Propanamine), NDBA (N-nitroso dibutylamine), NMPA (N-nitroso-N-methylamine), NMBA (N-Nitroso-N-methyl butyric acid), NPI (N-nitroso piperidine), MeNP (1-methyl-4-nitroso piperazine), NMOR (N-nitroso morpholine), NDIPA(N-nitroso-di-n-propylamine), etc. are considered by an international regulatory body to exhibit a toxicological profile like NDMA (N-nitroso dimethylamine) and NDEA (N-nitroso diethylamine).

Other authorities, such as the USFDA, and the EMA-European Union (EU), followed an Article 31 review of Sartans at risk of containing (those containing a tetrazole ring) nitrosamine impurities.