ICH Q4B Annex 14 Bacterial endotoxins tests

  • Email
  • Help
Current effective version

Adopted 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

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 0 ratings

Add your rating:

See all ratings
0 ratings
0 ratings
0 ratings
0 ratings
0 ratings
    

Tell us more