null New edition of the Technical Guide for the elaboration of Ph. Eur. monographs ready for publication

EDQM Strasbourg, France 07/07/2022
New edition of the Technical Guide for the elaboration of Ph. Eur. monographs ready for publication

At its 173rd session, the European Pharmacopoeia Commission approved the publication of a new edition of the Technical Guide for the elaboration of monographs. This guide is an essential aid both to the drafting of monographs and for the transposition of analytical techniques into a pharmacopoeial procedure. It helps ensure a high level of harmonisation throughout the texts of the Ph. Eur., all of which are written by the experts of the different groups and, together with the Style Guide, can also serve more widely as a means of better understanding the requirements, format and set-up of a monograph.

With the previous version of the Guide dating back to 2015, it was clear that a substantial overhaul of the text would be necessary to incorporate the technical progress and new policies that have been adopted in the intervening years.

The 8th edition of the Technical Guide, as recently approved by the Ph. Eur. Commission, therefore contains all-new sections in addition to the existing parts, now comprehensively updated, to reflect these changes. The revision of the General Notices (1.), the implementation of the general chapter Balances (2.1.7) and the harmonisation of the general chapter, Degree of coloration of liquids (2.2.2), prompted several editorial and technical modifications, with other changes, such as the switch to a molecular sieve from phosphorous pentoxide in the revised general chapter Loss on drying (2.2.32), also now reflected.

This revised technical guide also applies to medicinal product monographs, where appropriate, and a reference to the Technical Guide on elaboration of monographs on medicinal products containing chemically defined active substances has been included as a footnote.

Other highlights of this new edition are the updated policy on substances with stereocenters, a more detailed description of the use of second identification tests and the possibility of including resolution criteria greater than 5.0 if no other critical pair is present in the chromatogram. The Guide now explains when a reporting threshold should be included in the analytical procedure, depending on the quantitation procedure used (external standardisation or normalisation) and whether one impurity or several (including the total) are to be quantified, and offers an updated policy on genotoxic impurities, amended to take account of the implementation of the ICH M7 guideline in the Ph. Eur.

The Guide, together with other guides dedicated to special classes of substances and products, are available on a dedicated page of the EDQM website.