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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