European Pharmacopoeia Abolishes Rabbit Pyrogen Test

Date

July 24, 2024

Category

EU Regulations

Description

At their session June 2024 the European Pharmacopoeia Commission decided that they would abolish the use of the traditional rabbit pyrogen test (RPT) from 1 July 2025. From this date, it will be the responsibility of medicine developers to select a suitable in vitro test, based on a risk assessment, to control the pyrogenicity of their product.

European Pharmacopoeia monographs Water for injections (0169) and Purified water (0008) were revised earlier in 2024 to allow the use of recombinant factor C (rFC) to test for bacterial endotoxins.