ICH Q4B Annex 6 Uniformity of dosage unites general chapter

Current effective version

PDF iconAdopted guideline

Reference numberEMA/CHMP/ICH/645408/2008
Published31/01/20014
Effective from01/06/2014
KeywordsDosage units, content uniformity, pharmacopeia
DescriptionThis annex is the result of the Q4B process for the Uniformity of Dosage Units General Chapter. The proposed texts were submitted by the Pharmacopoeial Discussion Group. It aims to facilitate the recognition of pharmacopoeial procedure for the uniformity of dosage units by regulatory authorities in the ICH regions. It describes special requirements for this test to be considered interchangeable for use in the ICH regions.


Document history

First version

Current version

PDF iconAdopted guideline


PDF iconDraft guideline

In operation: 01/06/2014–present


Published: 01/12/2008


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