Endotoxin testing is a critical step in ensuring the quality and safety of many sterile pharmaceutical products.
The Bacterial Endotoxins Test (BET) described in USP General Chapter <85> Bacterial Endotoxins Test is a test to detect or quantify endotoxins from Gram-negative bacteria using amoebocyte lysate from the horseshoe crab.
Whereas General Chapter <86> Bacterial Endotoxins Test Using Recombinant Reagents provides techniques for bacterial endotoxin testing using non-animal derived reagents. The new chapter includes methods that use both recombinant cascade (rCR) and recombinant Factor C (rFC) reagents and provides information for manufacturers of new and existing pharmaceutical products on how to incorporate them into their quality testing.
The USP Endotoxin Reference Standard helps support the testing outlined in both chapters. As per General Chapter <85> regarding the preparation of solutions: "A Standard Endotoxin Stock Solution is prepared from a USP Endotoxin Reference Standard that has been calibrated to the current WHO International Standard for Endotoxin."
