Back Ph. Eur. allows the use of recombinant factor C for control of bacterial endotoxins in water monographs

EDQM Strasbourg, France 13/092023
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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.

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