1. Home
  2. News
  3. Risk evaluation of nitrosamines in pharmaceuticals

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
Serap.Acikgoez(at)tentamus.com

Contact

Source: https://www.dsi-pharm.de/en/risk-evaluation-nitrosamines/

Tentamus laboratories in your vicinity