EP monographs allow rFC for water testing

Revised versions of two widely used European Pharmacopoeia (EP) monographs now allow the use of recombinant factor C (rFC) for testing of pharmaceutical waters.

The revised monographs – Water for injections (0169) and Purified water (0008) – mean that users can select the rFC test described in Ph. Eur. 2.6.32 directly when testing pharmaceutical waters. A side-by-side comparison against the tests described in general chapter 2.6.14. Bacterial endotoxins is no longer needed.

The new monographs became effective on 1 April 2024.

The changes to the monographs were first published in Supplement 11.4 of the European Pharmacopoeia in October 2023. This followed a revision effort launched after the adoption of a new general chapter, Test for bacterial endotoxins using recombinant factor C (2.6.32), which came into force on 1 January 2021.

Traditionally, endotoxin testing methods have relied on Limulus Amoebocyte lysate (LAL) – derived from the blood of the horseshoe crab. Over recent years there has been a move to replace LAL with synthetic reagents, driven by sustainability, ethical and other considerations.

As a synthetic reagent rFC does not rely on the use of animal-derived products. 

Cathie Vielle, Head of the European Pharmacopoeia Department at the EDQM and Secretary to the European Pharmacopoeia Commission told EPR: “These revised monographs will allow users to select the rFC directly to test for bacterial endotoxins without the need for a side-by-side comparison against the LAL.”

“The use of the rFC is a step towards alleviating the need for species of horseshoe crab that are known to be endangered in some parts of the world,” she added.