ICH Q4B Annex 5 Disintegration test
Table of contents
This 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.
Keywords: Disintegration test, tablets, capsules, pharmacopoeia
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ICH guideline Q4B Annex 5 on evaluation and recommendation of pharmacopoeial texts for use in the ICH regions on disintegration test - general chapter - Step 5 (PDF/205.89 KB)
Adopted
First published: 11/02/2013
Last updated: 13/07/2017
Legal effective date: 01/12/2009
EMA/CHMP/ICH/308895/2008 -
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ICH: Q 4 B Annex 5: To note for evaluation and recommendation of pharmacopoeial texts for use in the ICH regions on disintegration test general chapter - Step 3 (PDF/162.17 KB)
Draft: consultation closed
First published: 01/06/2008
Last updated: 01/06/2008
EMEA/CHMP/ICH/308895/2008