Answer:
This question is addressed in the Ph. Eur. General Notices. The tests and assays described are the official methods upon which the standards of the Pharmacopoeia are based. With the agreement of the competent authority, alternative methods of analysis may be used for control purposes, provided that the methods used enable an unequivocal decision to be made as to whether compliance with the standards of the monographs would be achieved if the official methods were used (cross-validation). In the event of doubt or dispute, the methods of analysis of the Pharmacopoeia are alone authoritative. It is not the role of the EDQM to approve alternative methods or reagents.
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