ICH guideline
Q4B Annex 14 to note for evaluation and recommendation of pharmacopoeial texts
for use in the ICH regions on bacterial endotoxins tests – general chapter has
been adopted by the European Medicines Agency.
The document
allows for Ph.Eur. 2.6.14. Bacterial Endotoxins, JP 4.01 Bacterial Endotoxins
Test, and USP General Chapter <85> Bacterial Endotoxins Test, can be used
as interchangeable in the ICH regions. The proviso is that the gel-clot test
remains the reference test.
Furthermore, the
USP, JP, and Ph.Eur. reference standards are considered interchangeable as they
have been suitably calibrated against the WHO (World Health Organization)
International Standard for Endotoxin.
Document can be viewed here ICH Guideline Q4B Annex 14: Bacterial Endotoxins Test
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