United States Pharmacopeial Convention Inc.
11/01/2024 | Press release | Distributed by Public on 11/02/2024 00:05
Chapter for endotoxin testing using non-animal derived reagents published for early adoption
November 1, 2024
Rockville, MD - The U.S. Pharmacopeia (USP) has published the final text of Chapter <86> Bacterial Endotoxins Test Using Recombinant Reagents to the United States Pharmacopeia-National Formulary (USP-NF) for early adoption. The chapter, which provides additional techniques for bacterial endotoxin testing using non-animal-derived reagents, is scheduled to become official in May 2025.
Endotoxin testing is a critical step in ensuring the quality and safety of many sterile pharmaceutical products. Chapter <86> includes methods that use both recombinant cascade (rCR) and recombinant Factor C (rFC) reagents and provides information for manufacturers to incorporate these reagents into their quality testing.
Currently, the methods in Chapter <86> are considered alternatives to Chapter <85> Bacterial Endotoxins Test (BET). The definition of an alternative method can be found in General Notices 6.30: "An alternative method or procedure is defined as any method or procedure other than the compendial method or procedure for the article in question."
The addition of Chapter <86> to the US Pharmacopeia is in line with USP's commitment to expanding the use of animal-free methods and materials.
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