ICH Q4B Annex 5 Disintegration test
| Current effective version | |
| Reference number | CHMP/ICH/308895/08 |
| Published | 01/06/2009 |
| Effective from | 01/12/2009 |
| Keywords | Disintegration test, tablets, capsules, pharmacopoeia |
| Description | 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. |
Document history
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First version Current version |
In operation: 01/12/2009–present Published: 01/06/2008 |