28/29 February 2024
Supplement 11.2 to the European Pharmacopoeia (Ph.Eur.) came into force on 01 July 2023 and contains several updated monographs. As reported in a news in March, all CEP holders (Certificate of Suitability of Monographs of the European Pharmacopoeia - holders) are required to adapt their specifications and thus the respective CEPs to the new monographs.
Furthermore, five excipient monographs have been updated for this purpose, which now contain the so-called "functionality-related characteristics (FRCs)" section. In total, there are now more than 100 Ph.Eur. Monographs that contain this section. This is intended to highlight the chemical and physical characteristics of excipients that could affect the functionality in a particular dosage form of a medicinal product. This information is not mandatory, but can provide helpful information, for example, for the development of new dosag forms and ultimately for the quality of the product.
The "Excipient Performance Working Party (EXP WP)" compiles the data for the FRCs sections, defines the associated test methods and checks existing monographs with and without FRC sections for updates. The latter is carried out in order to take into account the different types of use of excipients in medicinal products as fully as possible and to map them accordingly in the FRCs sections.
The chapter "5.15. Functionality-related characteristics of excipients" additionally contains general information on the FRCs.
Information on the FRCs for excipients and further information on Addendum 11.2 to the European Pharmacopoeia (Ph.Eur.) can be found on the EDQM website.