EDQM FAQs
- General chapter 5.1.13 entered into force on 1 July 2025. Does this new chapter apply to new products only?
- What methods should users employ now that the rabbit pyrogen test (RPT) is no longer an official Ph. Eur. test?
- What changes were made to general chapter 2.6.14. Bacterial endotoxins?
- Does the Ph. Eur. favour limulus amoebocyte lysate (LAL)-based methods over the recombinant factor C (rFC)-based method?
- I would like to use recombinant factor C (rFC), do I need to perform a validation?
- 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?
- What are the benefits of recombinant factor C (rFC)?
- What is the status of recombinant cascade reagents (rCR) in the Ph. Eur.?
- Does the revised version of general chapter 2.6.14. Bacterial endotoxins depart from the internationally harmonised version?