The European Pharmacopoeia (Ph. Eur.) has launched a public consultation on a new general chapter, 2.6.32. Test for bacterial endotoxins using recombinant factor C (rFC). This is not a new topic for the Ph. Eur. which was one of the first pharmacopoeias to refer to rFC, namely in chapter 5.1.10 Guidelines for using the test for bacterial endotoxins in Supplement 8.8 (2016), allowing the recombinant protein to be used as an alternative to limulus amoebocyte lysate. Now, the Ph. Eur. is moving another step forward by publishing a standalone chapter on the test for bacterial endotoxins (BET) using rFC. This is a significant development since, for the BET, the world currently depends on a single source of lysate, the horseshoe crab family, and more specifically, two species of the crab, Limulus polyphemus and Tachypleus tridentatus, both of which are known to be endangered.
This chapter describes a BET that uses a rFC based on the gene sequence of the horseshoe crab for the quantification of endotoxins from gram-negative bacteria, and a fluorimetric end-point detection method. For now, only the fluorimetric method is described in the new chapter as the rFC kits currently available on the European market and most of the available scientific data are based on this method.
It is important to highlight that for the time being, this will be a standalone chapter which will therefore not be referenced in individual monographs.
Users and other interested parties can submit their comments on the text, published in Pharmeuropa 31.1, until 31 March 2019 by using the EDQM online Helpdesk.
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