Nitrosamine Impurities: EDQM completes General Monographs 2034 and 2619
The European Pharmacopoeia Commission adopted the two revised general monographs Substances for pharmaceutical use (2034) and Pharmaceutical preparations (2619). These monographs were each extended by a section containing requirements with regard to possible contamination by nitrosamines.
Manufacturers of APIs must observe the following requirements:
- For each API, a risk assessment on possible nitrosamine impurities has to be carried out. This must include the entire manufacturing process as well as the storage of the API.
- If such a risk is identified, measures must be taken to minimise the risk (e.g. through changes in the manufacturing process).
- A control strategy must be implemented to reliably detect and monitor nitrosamine contamination.
The revised monographs will appear in Supplement 11.3 of the European Pharmacopoeia in July 2023 and will be effective from January 2024.
See Ph. Eur. Publication schedule
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