Since the start of the sartan crisis in summer 2018, OMCLs of the European Network have elaborated a number of test methods to qualify and quantify nitrosamines in Active Pharmaceutical Ingredients (APIs) and drug products of the sartan group. While at the beginning, work focused on the two major reported contaminants, N-nitrosodimethylamine (NDMA) and N-nitrosodiethylamine (NDEA), laboratories of the Network are now extending their test methods to other potential nitrosamines.

Recently, the first method for the determination of N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) developed by the Bavarian OMCL at the “Landesamt für Gesundheit und Lebensmittelsicherheit” (LGL) has been published on the EDQM website under “Ad-hoc projects of the OMCL Network”. This LC-MS/MS method is validated for the quantification of NMBA in losartan K drug substance.