European Pharmacopoeia
The European Pharmacopoeia is published by the European Directorate for the Quality of Medicines & HealthCare (EDQM) of the Council of Europe in Strasbourg. The publication contains standardised specifications defining the quality of pharmaceutical preparations, their constituents and containers.
The Finnish Medicines Agency Fimea is the Finnish national authority in pharmacopoeia matters.
The European Pharmacopoeia can be ordered from EDQM Online Store.
Valid version of the European Pharmacopoeia
The second supplement of the eleventh edition of the European Pharmacopoeia (European Pharmacopoeia 11th Edition, supplement 11.2) has been implemented on July 1st, 2023.
The National pharmacopoeia documents have been updated according to the eleventh edition.
New texts in Supplement 11.2
Monographs
- Mirabegron (3132)
- Propylene glycol monocaprylate (2799)
- Saxagliptin monohydrate (3136)
Herbal drugs and herbal drug preparations
- Pumpkin seed (2941
Special notices
Infliximab concentrated solution (2928), Isoniazid (0146), Lactose (1061), Lactose monohydrate (0187), Levomepromazine hydrochloride (0505) and Sevoflurane (2269)
An error has been detected in texts mentioned on the headline that were published in the English-language print version of Ph. Eur. Supplement 11.1. Due to a technical issue, the figures (chemical structures and chromatogram) are missing. This issue does not concern the French version of the monographs or Ph. Eur. online (English and French). The missing figures will be reintroduced in Ph. Eur. Supplement 11.3.
Read more (includes also the corrected texts): Erratum for Infliximab concentrated solution (2928), Isoniazid (0146), Lactose (1061), Lactose monohydrate (0187), Levomepromazine hydrochloride (0505) and Sevoflurane (2269)
2.2.46 Chromatographic separation techniques
The general chapter “Chromatographic separation techniques (2.2.46)” was revised in the 11th Edition of the European Pharmacopoeia in the framework of international harmonisation. After approval of the text, problems were revealed with one of the approved changes regarding instructions on calculation of signal-to-noise (S/N) ratio. Users are advised to continue using the earlier instructions.
The chapter has already been revised again. The new version, where the old instructions are restored, will be included in Supplement 11.3, which will be implemented on January 1st 2024 and which will be published in July 2023.
Read more on EDQM webpage: Signal-to-noise ratio: revision of Ph. Eur. general chapter Chromatographic separation techniques (2.2.46)
Human coagulation factor IX (1223)
An error has been detected in the English version of the corrected monograph on Human coagulation factor IX (1223). Three lines of the Labelling section were erroneously deleted. The missing three lines of the Labelling section will be formally reintroduced in Ph. Eur. Supplement 11.3 which will be implemented in 1.1.2024 and published in July 2023. Until then the corrected text can be found from Pharmeuropa webpage.
Read more (includes also the corrected text): Erratum - Human coagulation factor IX (1223)