Back Update on detection of nitrosamines in valsartan and validated testing method

EDQM Strasbourg, France 14/09/2018
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The EDQM continues investigating and defining actions to address the presence of all kinds of nitrosamines, including NDMA and NDEA in valsartan and other sartans which may be affected. As mentioned in a previous press release, the EDQM has contacted those manufacturers holding CEPs (Certificates of Suitability to the monographs of the European Pharmacopoeia) and whose substances may present a risk of contamination with nitrosamines.

N‑nitrosodiethylamine (NDEA) has been detected in valsartan made by Zhejiang Huahai using the same manufacturing process as the one used before changes were introduced in 2012 to the process covered by the CEP. This process is included in the current investigations made by the EDQM.

The EDQM is continuing involvement in the coordination of the activities of the Official Medicines Control Laboratories (OMCLs) Network in Europe to ensure that methods are available to control these impurities.  

Both NDEA and NDMA belong to the class of nitrosamines and are classified as probable human carcinogens (substances that may cause cancer).