News about GMP/cGMP

06.09.2019

EMA: Limits for further nitrosamines in sartans

In summer 2018, production-related contamination of the antihypertensive valsartan with the nitrosamines NDMA and NDEA caused a stir in the pharmaceutical world (we reported). A risk assessment conducted by the European Medicines Agency (EMA) followed this. The results can be found in the detailed EMA report from February 2019.

The EMA report also contains information on the third nitrosamine contamination by NMBA. In the beginning of July 2019, the new Sartan monographs were included in the European Pharmacopoeia. However, the monographs only take NDMA and NDEA into account. On August 20, 2019, the EMA released additional limits for the structurally related nitrosamines NMBA, DIPNA and EIPNA.
In February 2019, the  Committee for Medicinal Products for Human Use (CHMP) of the EMA published a first conclusion on the case of valsartan and other sartanes contaminated with nitrosamines. Soon after, there were further batch recalls of losartan in both Germany and the USA. However, NMBA was found in these batches, not NMDA and NDEA.

Glossary of nitrosamines:

NDMA: N-nitrosodimethylamine

NDEA: N‑nitrosodiethylamine 

NMBA: N-nitroso-N-methylamino butyric acid

DIPNA: N-nitrosodiisopropylamine

EIPNA: N-nitrosoethylisopropylamine


Sources:

DAZ.Online: Newsportal

EMA: Report on new limits



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