The European Pharmacopoeia (Ph. Eur.) Commission held its 173rd session on 21 and 22 June 2022. Forty-eight texts were adopted and will be published in Ph. Eur. Supplement 11.2, effective as of 1 July 2023.
Of these 48 texts, four were new monographs: Pumpkin seed (2941), Propylene glycol monocaprylate (2799), Mirabegron (3132) and Saxagliptin monohydrate (3136).
The remaining 44 were revisions and included:
- 6 monographs on excipients revised to include a functionality-related characteristics (FRC) section and 2 others whose FRC section had been updated. As of Supplement 11.2 and with these 6 additions, the Ph. Eur. will contain more than 100 excipient monographs with an FRC section supporting the definition of critical material attributes for specific applications;
- a revised version of the general monograph on Monoclonal antibodies for human use (2031), to ensure alignment with the dosage form monograph Parenteral preparations (0520) with regard to visible particles. The revised monograph now refers directly to new general chapter 5.17.2. Recommendations on testing of particulate contamination: visible particles, and includes the requirement ‘practically free from visible particles’ for liquid parenteral preparations, together with recommendations on testing for visible particles;
- four monographs on somatropin revised to harmonise their content. In particular, the analytical procedure capable of detecting additional oxidised forms already included in Somatropin injection (2370) was also introduced in Somatropin concentrated solution (0950), Somatropin (0951) and Somatropin powder for injection (0952). In combination with the CZE detection of deamidation forms, this approach offers a superior control of the related proteins in somatropin.
For more information, read the press release “Outcome of the 173rd session of the European Pharmacopoeia Commission, June 2022”.