The 168th session of the European Pharmacopoeia (Ph. Eur.) Commission took place on 24 and 25 November 2020.
At this session, the Commission adopted 114 texts for publication in Ph. Eur. Supplement 10.6, including 101 revised texts and the following 13 new texts:
- 4 general chapters: Particulate contamination: sub-visible particles in non-injectable liquid preparations (2.9.53), Balances for analytical purposes (2.1.7), N-Nitrosamines in active substances (2.5.42) and Contaminant pyrrolizidine alkaloids (2.8.26); and
- 9 individual monographs: Trazodone hydrochloride (2857), Phenoxybenzamine hydrochloride (2983), Methylaminolevulinate hydrochloride (3073), Vibriosis vaccine (inactivated) for sea bass (3090), Fluticasone furoate (2768), Toxicodendron quercifolium for homoeopathic preparations (2519), Sanguinaria canadensis for homoeopathic preparations (2687), Thunberg fritillary bulb (2588) and Scrophularia root (2973).
Further information on specific outcomes will be published on the website of the European Directorate for the Quality of Medicines & HealthCare (EDQM) soon, including the new Ph. Eur. approach for dissolution or disintegration tests described in a revised version of Ph. Eur. chapter 1. General Notices, the general chapters N-Nitrosamines in active substances (2.5.42) and Contaminant pyrrolizidine alkaloids (2.8.26) and the monograph Thunberg fritillary bulb (2588).
For more information, read the press release “Outcome of the 168th session of the European Pharmacopoeia Commission”.