Revised versions of the widely used monographs, Water for injections (0169) and Purified water (0008), will be published in Supplement 11.4 of the European Pharmacopoeia (Ph. Eur.).
Adopted by the Ph. Eur. Commission at its 175th session in March this year, these two fundamental texts now allow the use of recombinant factor C (rFC) to test for bacterial endotoxins in pharmaceutical waters. The revision work was launched after the Ph. Eur. Commission adopted a new general chapter, Test for bacterial endotoxins using recombinant factor C (2.6.32), describing a bacterial endotoxin 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 general chapter was published in Supplement 10.3 and came into force on 1 January 2021.
For users, this 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.
In contrast to LAL, rFC is a synthetic reagent that does not rely on lysate derived from species of horseshoe crab that are known to be endangered in some parts of the world. The use of rFC is therefore a step towards alleviating the need for these animal resources. The revised monographs will be published in Supplement 11.4 of the Ph. Eur. (October 2023), with an implementation date of 1 April 2024.
See also:
- European Pharmacopoeia 11th Edition
- Outcome of the 175th session of the European Pharmacopoeia Commission, March 2023
- Recombinant factor C: new Ph. Eur. chapter available as of 1 July 2020
- Webinar “Using recombinant factor C for bacterial endotoxin testing in the Ph. Eur.: how far have we come, how far have we to go?”