ICH 4 QB Annex 9 Tablet friability

Current effective version

PDF iconAdopted guideline

Reference number CHMP/ICH/379801/09
Published 01/12/2009
Effective from 01/05/2010
Keywords Tablet friability, pharmacopoeia
Description This 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

PDF iconAdopted guideline


PDF iconDraft guideline

In operation: 01/05/2010–present


Published: 01/06/2009

Related content

How useful was this page?

Add your rating