News about GMP/cGMP

26.02.2021

EDQM: Five Pharmacopoeia monographs on Nitrosamine contamination in Sartans revised and implemented immediately

EDQM: Five Pharmacopoeia monographs on Nitrosamine contamination in Sartans revised and implemented immediately

On 23 February 2021, the European Directorate for the Quality of Medicines & HealthCare (EDQM) announced that five monographs on sartans have been revised. They will be effective immediately as of 1 April 2021. 


This concerns the following sartans with a tetrazole ring: 

  • Valsartan (2423) 
  • Losartan potassium (2232) 
  • Irbesartan 
  • Candesartan cilexetil (2573) 
  • Olmesartan medoxomil (2600) 

The monographs are thus consistent with the latest regulatory recommendations issued by the Committee for Medicinal Products for Human Use (CHMP) on 13 November 2020 (see EMA nitrosamine website). Therefore, they were not published in the Pharmeuropa for public consultation. In addition, the monographs were implemented in a rapid revision process to best align the effective date with regulatory decisions.  

The changes concern a new wording of the section "Production" and the deletion of the section on N-nitrosamine testing.  

The monographs can be found in Supplements 10.4 and 10.5 in the download version. The PDF is available on the EDQM website. In the print version, you will find the monographs starting in Supplement 10.6.  

Two other monographs have also been revised. They now contain recommendations for manufacturers on the handling and evaluation of nitrosamine impurities in active substances and medicinal products for human use:  

  • Substances for pharmaceutical use (2034)   
  • Pharmaceutical preparations (2619)  

These monographs will be published in Pharmeuropa 33.2 (April to June 2021). 


Sources:

EDQM: European Pharmacopoeia: Rapid implementation of the revised sartan monographs on 1 April 2021 

EDQM: Control of N-nitrosamine impurities in sartans: revision and rapid implementation of five Ph. Eur. monographs 


 

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