ICH Q4B Annex 5 Disintegration test

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Current effective version

Adopted guideline

Reference numberCHMP/ICH/308895/08
Published01/06/2009
Effective from01/12/2009
KeywordsDisintegration test, tablets, capsules, pharmacopoeia
DescriptionThis annex is the result of the Q4B process for Disintegration Test General Chapter. The proposed texts were submitted by the Pharmacopoeial Discussion Group. It aims to facilitate the recognition of pharmacopoeial procedures for the disintegration test by regulatory authorities in the ICH regions. It describes special requirements for this test to be considered interchangable for use in the ICH regions.


Document history

First version

Current version

Adopted guideline


Draft guideline

In operation: 01/12/2009–present


Published: 01/06/2008


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