Since early July 2018 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 tetrazole structure. 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.
Today the first method for simultaneous determination of NDMA and NDEA in sartan tablets, developed and validated for Valsartan tablets has been released by the German OMCL in Karlsruhe. It is based on the principle of UHPLC-APCI-MS/MS and allows to determine simultaneously both contaminants.
Additional methods based on different analytical principles will be published once available.
Full detail on this new CVUA Karlsruhe method can be found here.