ICH Q4B Annex 7 Dissolution test

Current effective version

PDF iconAdopted guideline

Reference number CHMP/ICH/645469/08
Published 01/12/2009
Effective from 01/05/2010
Keywords Dissolution test, solid dosage form, pharmacopoeia, basket apparatus (apparatus 1), paddle apparatus (apparatus 2), flow-through cell, validation
Description This 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

PDF iconAdopted guideline


PDF iconDraft guideline

In operation: 01/05/2010–present


Published: 01/12/2008

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