As the requirements for related substances in Ph. Eur. monographs have been adapted in accordance with the principles of ICH Guideline Q3A(R2), there is a need for more appropriate format for quantitative purposes. The Chairs of EDQM's Chemical Groups have developed a model text to which new or revised monographs would be adapted.
In European Pharmacopoeia monographs, the acceptance criteria for related substances have so far usually been expressed in terms of comparison of peak areas (“… not more than the area of the principal peak in the chromatogram obtained with reference solution …”), which, strictly speaking, leads to a pass/fail decision but not to a true quantitative test result.
Send your comments to the appropriate national pharmacopoeia authority. Readers from countries that are not members of the European Pharmacopoeia Commission should send their comments directly to the European Directorate for the Quality of Medicines and HealthCare (EDQM). Comments on this proposal should be submitted by 30 May 2010.
EDQM/ Announcement and Model Text