INTRODUCTION

The first version of Bacterial Endotoxins Test 〈85〉 appeared in USP 20–NF 15 (1980). The chapter was subsequently harmonized with the Japanese Pharmacopoeia and European Pharmacopoeia, and the first harmonized chapter appeared in USP 25–NF 20 (2002). Bacterial Endotoxins Test Using Recombinant Reagents 〈86〉 has since been added in USP–NF 2025 Issue 1, which contains additional techniques using nonanimal-derived reagents. Since the first publication of 〈85〉, the content has changed very little, but years of experience, increasing knowledge, and more complex parenteral formulations suggest that the basic methodologies described herein could benefit from additional supporting information. The purpose of this general information chapter is to provide additional background information and guidance for the performance and proper application of the compendial bacterial endotoxins tests.