Pyrogen detection is essential for ensuring the safety of parenteral medicines. For decades, the rabbit pyrogen test (RPT) has been the traditional method.
The RPT involves measuring the rise in body temperature in rabbits following intravenous injection of the substance to be examined.
Despite multiple efforts to encourage medicine developers to move away from the RPT, the test is still widely used to detect pyrogenic substances, consuming a large number of rabbits worldwide.
At its 179th session in June 2024, as the outcome of a broad exercise aiming at the complete removal of the RPT from the European Pharmacopoeia (Ph. Eur.), the Ph. Eur. Commission adopted 57 revised texts from which the RPT has been deleted, together with a new general chapter on Pyrogenicity (5.1.13), marking the end of the RPT era in the Ph. Eur…
