On April 2, 2019, the European Commission issued its final, legally binding decision on drugs containing valsartan, candesartan, irbesartan, losartan and olmesartan. Since these sartans have a tetrazole group, there is a risk of contamination with nitrosamines. Under the above decree, companies must review manufacturing processes to prevent the presence of nitrosamine contaminants.
As a result, the new sartan monographs were included in the European Pharmacopoeia at the beginning of July.
These are the sartan monographs concerned:
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