The European Pharmacopoeia Commission (EPC) held its 177th session on 21 and 22 November 2023. The EPC adopted 77 texts at this session, to be published in European Pharmacopoeia (Ph. Eur.) Supplement 11.6 (July 2024) and be effective as of 1 January 2025.
These 77 texts included nine new individual monographs on:
- Chloroxylenol (2980), Etravirine (3121) and Ursodoxicoltaurine dihydrate (3150) ;
- Clematis rhizome and root (2527), Hedge mustard (2942), Loquat leaf (2978) and Sesame seed (2979) ;
- Ioflupane (123I) injection (3144) ;
- Golimumab concentrated solution (3103).
New versions of 68 texts were also adopted, including the monograph on Propylene Glycol (0430). The monograph was revised in response to the public health risk posed by the discovery of ethylene glycol (EG) and diethylene glycol (DEG) contamination in several medicinal products in African and Asian countries (WHO alerts No. 6-7/2022, No. 1/2023 and No. 4-6/2023). Further updates to the monograph include an identification test by infrared (IR) spectrophotometry and a modernised procedure for the Acidity test. The monograph has been pre-published on the website of the European Directorate for the Quality of Medicines & HealthCare (EDQM) to give users advance warning of the upcoming change.
It was also agreed to look closer into potentially revising monographs on substances at risk of adulteration with EG and DEG and to liaise with international stakeholders on the topic.
For more information, read the press release “Outcome of the 177th session of the European Pharmacopoeia Commission, November 2023”.
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