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EDQM: Related Substances
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.
Outcome:
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.