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Nitrosamine Impurities | EDQM Supplements General Monographs 2034 and 2619

At its 174th meeting in November 2022, the European Pharmacopoeia Commission adopted the two revised general monographs Substances for pharmaceutical use (2034) and Pharmaceutical preparations (2619) .

Based on the comments received during the last round of consultations in Pharmeuropa , a section was added to each of the two monographs containing requirements regarding possible contamination by nitrosamines .

Accordingly, manufacturers of active pharmaceutical ingredients must observe the following requirements:

  • A risk assessment of possible nitrosamine contamination must be prepared for each active ingredient. The entire manufacturing process as well as the storage of the active substance must be included.
  • If such a risk is identified, measures must be taken to minimize the risk (e.g. changes in the manufacturing process).
  • A control strategy must be implemented that reliably detects and monitors nitrosamine contamination.

These core requirements are supplemented in the section of the monograph Pharmaceutical preparations (2619) with the restriction that these requirements do not apply to manufacturers of veterinary medicinal products and unlicensed products ( "... manufacturers of medicinal products, except products for veterinary use only and unlicensed pharmaceutical preparations..." ) and that for the risk assessment the entire shelf life of the product has to be considered according to the requirements of the regulatory authorities.

The revised monographs will appear in Supplement 11.3 of the European Pharmacopoeia in July 2023 and will apply from January 1, 2024.

Further information on the subject of nitrosamine contamination can be found under the heading N-nitrosamine contamination in brief on the EDQM website.

Read also: Nitrosamine Risk Assessment

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