General chapter 2.6.32. Test for bacterial endotoxins using recombinant factor C was published in Supplement 10.3 of the European Pharmacopoeia (Ph. Eur.) and came into force on 1 July 2021. This new general chapter describes a bacterial endotoxins test (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 European Directorate for the Quality of Medicines & HealthCare (EDQM) has now published updated versions of two fundamental Ph. Eur. monographs in Pharmeuropa 34.3 (July 2022) for comment: Water for injections (0169) and Purified water (0008). Both texts have been revised to allow the use of recombinant factor C (rFC) to test for bacterial endotoxins, as described in general chapter 2.6.32. For users, this proposed revision will mean that they can select the test described in 2.6.32 directly when testing pharmaceutical waters, i.e. without a side-by-side comparison against the tests described in general chapter 2.6.14 Bacterial endotoxins…
