Methods for determination of NDMA and NDEA in sartans
The Official Medicines Control Laboratories (OMCLs) of the General European OMCL Network (GEON) are involved in investigations and actions to address the issues related to the detection of N-nitrosodimethylamine (NDMA) and N-nitrosodiethylamine (NDEA) in valsartan and related sartans. The Network has developed methods for the specific testing of nitrosamines in sartans on the basis of different analytical principles.
The Irish OMCL in the Public Analyst’s Laboratory in Galway (PALG), the French OMCL at the ANSM site in Montpellier, the Chemisches und Veterinär-Untersuchungsamt (CVUA) Karlsruhe and the OMCL at Swissmedic established different methods on behalf of the Network.
These methods are publicly available and can be accessed below:
- NEW: the Swissmedic method (limit test) is based on GC-MS (Liquid-direct-injection) and allows determination of both NDMA and NDEA simultaneously in sartans. Please note that prior to use, the method must be appropriately validated. The German version is the official version. In order to access the official version please use the following link.
- the CVUA Karlsruhe method is based on UHPLC-APCI-MS/MS and allows determination of both NDMA and NDEA simultaneously in sartans.
- The PALG method is based on Headspace GC MS (single quad) and applicable to the determination of NDMA in Active Pharmaceutical Ingredients (API) and corresponding powdered tablets of the sartan group.
- The ANSM method is based on HPLC-UV and applicable to the determination of NDMA in API and corresponding powdered tablets of valsartan.
- The CVUA Karlsruhe method is based on APCI-UHPLC-MS/MS and applicable to the detection and quantitative determination of NDMA in valsartan drug products.
Please note that OMCLs of the General European Network are by their status and role only performing tests on behalf of competent authorities and for that reason are not in the position to accept contract work for private companies.
The U.S. FDA has also published methods for determination of NDMA and NDEA.