Dear Mms and Sirs,
You are sure to be informed about it: Nitrosamines in medicinal products – after valsartan, ranitidine now metformin! Press release from BfArM as of 10/16/2020: The EU supervisory authorities request nitrosamine tests on medicinal products containing metformin. “The European Medicines Agency EMA and the competent national authorities in the EU will contact all marketing authorization holders of metformin-containing medicinal products and ask them to test all metformin-containing finished medicinal products for the presence of nitrosamines before they are released on the market.
This is a preventive measure, to ensure the safety of the patients while the ongoing investigations on these drugs are completed. ” At AZ-Biopharm, we established a GC-MS method with a sensitivity that allows us to detect nitrosamines (NMDA) into metformin finished drug product formulations. In addition, we have established a highly sensitive LC-MSMS method that allows orthogonal verification of the GC results or can be used as a test method itself. This method can easily be adapted to your medicine.