Registration Board in its 323rd meeting observed that various USP monographs for drug products prescribe more than one dissolution tests and that the pharmacopoeia in such cases recommends that “When more than one Dissolution Test is given, the labeling states the Dissolution Test used only if Test 1 is not used.”
Keeping in the USP labeling requirements narrated above and to comply to the Pharmacopeial specifications, the Board decided as under:
“The manufacturer shall mention the dissolution test Number on the secondary packing / unit carton of product for dissolution tests No 2,3 or 4 as per requirement of USP otherwise it would be presumed that dissolution test No.1 shall be performed on the finished product.”
Accordingly, the decision of Registration Board is circulated for information and compliance by relevant stakeholders / manufacturers.