Press release BfArM October 16, 2020
The EU supervisory authorities require nitrosamine tests on medicinal products containing metformin.
„The European Medicines Agency (EMA) and the responsible 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 to the market.
This is a preventive measure to ensure patient safety while ongoing research on these drugs is completed.“
We at AZ-Biopharm have a GC-MS method with a sufficient sensitivity for the quantification of nitrosamines (NMDA) in metformin FDP formulations. This method can be easily adapted to your medicinal product.