12 units from 12 different bottles should be used - Dissolution for Suspensions [Regulatives / Guidelines]

posted by jag009  – NJ, 2019-10-22 23:29 (1699 d 07:04 ago) – Posting: # 20714
Views: 2,049

Hi,

❝ I wonder why some of the USFDA BE recommendations has "Conduct comparative dissolution testing on 12 dosage units each of all strengths of the test and reference products" and other specify as "A total of 12 units from 12 different bottles should be used"?


Please cite reference for the 2nd recommendation.

J

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