News about GMP/cGMP

06.12.2019

Sartan monographs of the European Pharmacopoeia revised due to nitrosamine impurities

During the last months, there have been repeated cases of nitrosamine contamination in sartans (we reported). As a consequence, the sartan monographs of the European Pharmacopoeia were revised: Transiently, new strict limits apply for the contamination of sartans with nitrosamines. The monographs will come into force on January 1, 2020.

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

Swissmedic: News and Updates



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