Title: PYROGENICITY  
Author: MONTARD Laurence Jan 22, 2026
Last Changed by: MONTARD Laurence Jan 22, 2026
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Parent Page
    Page: General Chapters and Monographs
Children (9)
    Page: General chapter 5.1.13 entered into force on 1 July 2025. Does this new chapter apply to new products only?
    Page: What methods should users employ now that the rabbit pyrogen test (RPT) is no longer an official Ph. Eur. test?
    Page: What changes were made to general chapter 2.6.14. Bacterial endotoxins?
    Page: Does the Ph. Eur. favour limulus amoebocyte lysate (LAL)-based methods over the recombinant factor C (rFC)-based method?
    Page: I would like to use recombinant factor C (rFC), do I need to perform a validation?
    Page: I want to use recombinant factor C (rFC) for my bacterial endotoxins test (BET): do I have to validate its equivalence against Methods A-F?
    Page: What are the benefits of recombinant factor C (rFC)?
    Page: What is the status of recombinant cascade reagents (rCR) in the Ph. Eur.?
    Page: Does the revised version of general chapter 2.6.14. Bacterial endotoxins depart from the internationally harmonised version?
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Jan 22, 2026 14:50 MONTARD Laurence