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:

• Candesartancilexetil (2573)
• Irbesartan (2465)
• Losartan potassium (2232)
• Olmesartanmedoxomil (2600)
• Valsartan (2423)

Important changes:

• "Manufacturing" section: N-nitrosodimethylamine (NDMA) and N-nitrosodiethylamine (NDEA) are classified as suspected carcinogens. Manufacturers must ensure that these impurities do not arise in their processes. A transitional period of two years is granted to adapt manufacturing processes. Meanwhile, strict limit values apply.
• A test for nitrosamine impurities and set limit values can now be found in the "Purity testing" section.

Sources:

EDQM: Control of nitrosamine impurities in sartans: revision of five Ph. Eur. monographs

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