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) in valsartan. The Network has meanwhile developed methods for the specific testing of nitrosamines in sartans on the basis different analytical principles.
Three of these methods - established by the Irish OMCL in the Public Analyst’s Laboratory in Galway (PALG), by the French OMCL at the ANSM site in Montpellier and the German OMCL at the Chemisches und Veterinär-Untersuchungsamt (CVUA) Karlsruhe on behalf of the Network - are now publicly available and can be accessed via the following links - PALG method, ANSM method and CVUA Karlsruhe method.
- 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 uses HPLC-UV as general analytical principle for the determination of NDMA in valsartan (API and drug product).
- 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.