Nitrosamine Standards Update – NPIP, NDBA, and NMEA Now Available!

In the past few years, several medications have been recalled as a result of the discovery of two troublesome nitrosamine impurities, N-nitrosodimethylamine (NDMA) and N-nitrosodiethylamine (NDEA). While the amounts were extremely low, both compounds are suspected carcinogens and their detection in ingestible medicines gives a very high cause for concern. Upon further testing, another nitrosamine contaminant, N-nitroso-N-methyl-4-aminobutyric acid (NMBA), was also identified in some medications.

Human exposure to nitrosamines mainly occurs from use of tobacco products and consumption of cured and processed foods, but concern about manufacturing processes of certain blood pressure medicines has led manufacturers to include testing of a growing list of pharmaceuticals. Forward-looking analytical labs have developed screens that can alert to the presence of eight small molecule nitrosamines, including N-nitrosodimethylamine (NDMA), N-nitrosomethylethylamine (NMEA), N-nitrosodiethylamine (NDEA), N-nitroso-di-n-propylamine (NDPA), N-nitrosomorpholine (NMOR), N-nitrosopyrrolidine (NPYR), N-nitrosopiperidine (NPIP) and N-nitrosodi-n-butylamine (NDBA). Deuterated and native standards are available from stock for all these compounds. Find out more about CIL's full nitrosamine offerings by downloading our product spotlight.