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Endotoxin Detection - Recombinant Factor C

New Ph. Eur. Chapter Available as of 1 July 2020

July 02, 2020


Published in EuropeanPharmacopoeia Supplement 10.3, the new general chapter 2.6.32. Test for bacterialendotoxins using recombinant factor C describes a test for bacterial endotoxins (BET) that can be used as an alternative to the classic limulus amoebocyte lysate (LAL)-based methods for the quantification of endotoxins from gram-negative bacteria. The method described involves the use of a recombinant factor C rFC based on the gene sequence of the horseshoecrab and fluorimetric detection, in keeping with the kits currently available on the European market.

Also published in Supplement 10.3 is the revised chapter 5.1.10. Guidelines for using the test for bacterial endotoxins, which has been updated to reflect the new status of rFC-based methods and give prerequisites for their deployment by users of the pharmacopoeia.

See the original publication: Recombinant factor C: new Ph. Eur. chapter available as of 1 July 2020