At its 169th session (March 2021), the European Pharmacopoeia (Ph. Eur.) Commission adopted a revised version of chapter 1. General Notices.
Overhauled to provide greater clarity for users, the structure and content of the chapter have also been reviewed.
The chapter features new additions such as a section on monographs for medicinal products containing chemically defined active substances (reproducing the paragraphs on dissolution and disintegration as adopted by the Ph. Eur. Commission in November 2020 – see news of 10 December 2020). This new section also provides information on related substances and impurities taken from the relevant Technical Guide (Technical Guide for the elaboration of monographs on medicinal products containing chemically defined active substances [2020]).
The wording and terminology have been further harmonised and clarified. For example, synonyms have been weeded out, with “medicinal product” selected over the formerly interchangeable “finished product” and “pharmaceutical preparation”.
Further terminological changes include “shelf life” and “re-test period” instead of “period of validity” and “period of use”, in accordance with the ICH guidelines. Definitions have also been added for “freshly prepared solution” and “immediately before use”.
Another addition is a sub-section on “Demonstration of suitability of monographs” that provides useful guidance for users.
The scope of first and second identification series and of alternative identifications described in monographs have been clarified and several changes, including an explanation of the rounding rule, information on chiral substances and an example of equivalents, have been introduced in the tests and assay sections of the General Notices.
Lastly, all the paragraphs concerning monographs on herbal drugs that were previously dispersed throughout the text are now gathered together in a single section, for enhanced readability.
The revised chapter will be published in Ph. Eur. Supplement 10.7, available in October 2021.
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