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Risk evaluation of nitrosamines in pharmaceuticals

As of October 2020, EMA and the national competent authorities are asking marketing authorisation holders for metformin-containing medicines to test their medicines before releasing them onto the market. The risk evaluation for chemical medicines should be completed at the latest by 31 March 2021 and 1 July 2021 for biological medicines.

If a risk is identified for an active substance, marketing authorisation holders should proceed with confirmatory testing of the finished products identified to be at risk of N-nitrosamine formation. Precautionary testing to ensure patient safety are required for special drug products while the investigation is still ongoing.

The GMP-analytics experts at DSI-pharm support marketing authorisation holders to be in line with the requirements. A tailored solution is needed to overcome the hurdle of matrix effects and the low limit of quantifications.

“Our lab is capable to perform LC-MS or GC-MS depending on the matrix. Both methods are validated and can easily be adapted to all products. If necessary a product-specific full-validation according ICH-guidelines is performed. This is how we ensure the quality of your product!” explains Serap Acikgöz, Managing Director at DSI-pharm.

Do you have any questions about testing, or would you like to take advantage of our services? Our expert will be happy to advise you:

Dr. Serap Acikgöz
General Manager Pharma at DSI-pharm
Phone: +49 441 3613265 449


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