ICH Q4B Annex 14 Bacterial endotoxins tests

Current effective version

PDF iconAdopted guideline

Reference numberCHMP/ICH/529785/10
Published01/05/2013
Effective from01/05/2013
KeywordsBacterial endotoxins tests, pharmacopoeia
DescriptionThis annex is the result of the Q4B process for the Bacterial Endotoxins Test General Chapter. The proposed texts were submitted by the Pharmacopoeial Discussion Group. It aims to facilitate the recognition of pharmacopoeial bacterial endotoxins test procedures by regulatory authorities in the ICH regions.


Document history

First version

Current version

PDF iconAdopted guideline


PDF iconDraft guideline

In operation: 01/05/2013–present


Published: 24/09/2010


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