When we analyze the Uniformity of Dosage Units (content uniformity) in compressed tablets during PPQ, should we use the same or different methodology and acceptance criteria as those described in respective USP monograph (905) that is used for CU evaluation of routine product batches? Please explain.

When we analyze the Uniformity of Dosage Units (content uniformity) in compressed tablets during PPQ, should we use the same or different methodology and acceptance criteria as those described in respective USP monograph (905) that is used for CU evaluation of routine product batches? Please explain.

EBK A SMALL SCALE APPROACH TO ORGANIC L

4th Edition

ISBN:9781305446021

Author:Lampman

Publisher:Lampman

Chapter2: Crystallization

Section: Chapter Questions

Problem 3Q

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