ICH Q4B Annex 14 Bacterial endotoxins tests

  • Email
  • Help
Current effective version

Adopted guideline

Reference numberCHMP/ICH/529785/10
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

Adopted guideline

Draft guideline

In operation: 01/05/2013–present

Published: 24/09/2010

Related content

How helpful is this page?

Average rating:

 Based on 25 ratings

Add your rating:

See all ratings
5 ratings
5 ratings
5 ratings
5 ratings
5 ratings

Tell us more