The European Pharmacopoeia Commission (EPC) held its 174th session on 22 and 23 November 2022. The 85 texts adopted by the Commission at this session will be published in European Pharmacopoeia (Ph. Eur.) Supplement 11.3 (July 2023), with an implementation date of 1 January 2024.
These 85 texts included 13 new monographs and 1 new general chapter:
- monographs on:
- Dabigatran etexilate mesilate (3095), established under the P4 procedure;
- Levocetirizine dihydrochloride (3115); Bupivacaine (2761);
- Gallium (68Ga) oxodotreotide injection (3050); Gallium (68Ga) DOTA-NOC injection (3051);
- Eclipta prostrata (2852); Helichrysi flos (3089); Horse-chestnut bark (2945); Burdock root (2943); Adhatoda vasica leaf (2738);
- Lonicera japonica flower (3159); Chrysanthemum flower (3162);
- the general chapter entitled Particle size analysis by image analysis (2.9.48).
The Ph. Eur. Commission adopted revised versions of 72 texts. These included:
- the general chapter Friability of uncoated tablets (2.9.7), revised within the Pharmacopoeial Discussion Group (PDG) to unify the presentation of the apparatus dimensional requirements and to clarify the test criteria;
- the general chapter Osmolality (2.2.35), that now includes a more thorough calibration protocol with detailed preparation of standard solutions.
For more information, read the press release “Outcome of the 174th session of the European Pharmacopoeia Commission, November 2022”.