Since early July 2018 the Official Medicines Control Laboratories (OMCLs) of the General European OMCL Network (GEON) have been involved in investigations and actions to address the issues related to the detection of N-nitrosodimethylamine (NDMA) potentially present in valsartan and other sartan drugs containing a 5-substituted tetrazole structure (i.e. candesartan cilexetil, irbesartan, losartan, olmesartan medoxomil). NDMA is classified as a probable human carcinogen (a substance that could cause cancer) based on results from laboratory tests. Several analytical methods have been developed by the Network and published by EDQM. The Network has extended its efforts to develop methods for the specific testing of N-Nitrosodiethylamine (NDEA) in sartans.
Qualimetrix employs the analytical method proposed by the EDQM for the determination of NDMA and NDEA in various sartan APIs and final products.
The method is based on the principle of UHPLC-APCI-MS/MS that enables the simultaneous determination of both contaminants in all types of sartans.