ICH Q4B Annex 5 Disintegration test - Scientific guideline

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

Current effective version

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

Adopted Reference Number: EMA/CHMP/ICH/308895/2008 Legal effective date: 01/12/2009

Document history - First version (current)

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

Adopted Reference Number: EMA/CHMP/ICH/308895/2008 Legal effective date: 01/12/2009

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

Draft: consultation closed Reference Number: EMEA/CHMP/ICH/308895/2008