ICH 4 QB Annex 9 Tablet friability

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Current effective version

Adopted guideline

Reference numberCHMP/ICH/379801/09
Effective from01/05/2010
KeywordsTablet friability, pharmacopoeia
DescriptionThis annex is the result of the Q4B process for the Tablet Fragibility General Chapter. The proposed texts were submitted by the Pharmacopoeial Discussion Group. It aims to facilitate the recognition by regulatory authorities of pharmacopoeial analytical procedures and acceptance crieria relating to tablet friabilty for use in the ICH regions.

Document history

First version

Current version

Adopted guideline

Draft guideline

In operation: 01/05/2010–present

Published: 01/06/2009

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