Deadline for nitrosamine risk assessment extended to March 2021
The European Medicines Agency (EMA) has postponed the deadline for the risk assessment of possible N-nitrosamine formation or (cross) contamination,
- for chemical drugs until March 31, 2021,
- for biological drugs until July 1, 2021.
A risk assessment is required in any case. A report to EMA ist necessary in the event that nitrosamines are found in the end product. The Kirchhoff Berlin Institute offers analysis using GC-MS / MS and LC-MS / MS methods. Our procedures are based on the methods listed by the network of OMCLs (Official Medicines Control Laboratories) and, if necessary, are adapted and verified to your specific matrix.
Investigation of drugs containing metformin for nitrosamines since October 2020
Since this year manufacturers are obliged to test drugs containing metformin for nitrosamines before they are placed on the market. Here, too, we are happy to support you with the necessary analysis in the context of investigations and risk assessments.
Nitrosamines found in rifampicin-containing antibacterial drugs
Thanks to fast and flexible method development, we are able to detect the presence of typical nitrosamine impurities (1-nitroso-4-methylpiperazine, MeNP) in rifampicin samples. Rifampicin-containing tuberculosis drugs recently came into focus due to contamination with MeNP. In Europe, in the absence of limit values, pharmaceuticals are not yet to be withdrawn from the market, but their analysis and monitoring is urgently recommended. In the USA, however, the intake limits of 0.16 ppm for rifampicin with MeNP were set to avoid bottlenecks.
Secure yourself and contact us.
With a method newly developed by our task force, we are able to detect 1-nitroso-4-methylpiperazine (MeNP) in pharmaceutical products. Our method also allows us to screen up to 14 nitrosamines at the same time.
Further information from Mérieux NutriScience Group: