What are the brief procedures for analytical method validation (AMV) (Specificity and Method Precision) for content uniformity of capsule product?

23 August 2021 1 1K Report

While I understand the validation parameters and the procedures for assay AMV, I do not get the concept for determination of Specificity and Method Precision (Repeatability) for content uniformity.

Appreciate it if someone who has done AMV for content uniformity of tablets/capsules to answer my question. Thanks.

Andrei Blasko

The content uniformity is in fact an assay method with additional dose testing, thus content uniformity. There is an accuracy number for n>=6 and the associated relative standard deviation that need to meet the acceptance criteria.

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