ICH Q4B Annex 7 Dissolution test

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Current effective version

Adopted guideline

Reference numberCHMP/ICH/645469/08
Published01/12/2009
Effective from01/05/2010
KeywordsDissolution test, solid dosage form, pharmacopoeia, basket apparatus (apparatus 1), paddle apparatus (apparatus 2), flow-through cell, validation
DescriptionThis annex is the result of the Q4B process for the Dissolution Test General Chapter. The proposed texts were submitted by the Pharmacopoeial Discussion Group (PDG). It aims to facilitate the recognition of pharmacopoeial dissolution test procedures by regulatory authorities in the ICH regions. It lists special conditions for which dissolution test cannot be considered as interchangeable in the ICH regions.


Document history

First version

Current version

Adopted guideline


Draft guideline

In operation: 01/05/2010–present


Published: 01/12/2008


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