Overview of USP Chapter <86>
For the past 50 years, the Limulus amebocyte lysate (LAL) test has served as the foundation of endotoxin control for drug and medical device manufacturing. The United States Pharmacopeia (USP), however, has recognized the need to transition to recombinant methods, providing advantages in sustainability, conservation, and supply chain assurance.

Chapter <86> “contains additional techniques” to the Bacterial Endotoxins Test (BET) <85> allowing manufacturers to use recombinant Factor C (rFC) or recombinant cascade reagents (rCR) to detect or quantify endotoxins. These solutions eliminate reliance on animal-derived products and align with global efforts to reduce the risks associated with supply chain interruptions.

What does USP <86> mean for you?
Chapter <86> offers distinct advantages for pharmaceutical and medical device manufacturers:

• Sustainability: The new chapter facilities the use of non-animal derived reagents, reducing the use of materials derived from horseshoe crabs, contributing to sustainability efforts on a global scale.
• Streamlined Implementation: USP <86> includes stated requirements for rFC or rCR implementation included as verification steps for method suitability and for specific products.
• Simplified Validation: As per the USP FAQs document, “the user needs to review the primary validation package provided by the vendor (or developed internally) to ensure the validation status of the method is suitable for its intended use.” Additionally, “successful completion of these steps (primary validation review and successful completion of the Preparatory Testing in Chapter <86>) can be used to demonstrate that the method selected is appropriate for the specific material being tested.”

Download the scientific summary here and learn about the implications of the new USP Chapter <86> for endotoxin testing .