Guideline on Validation of the Limulus Amebocyte Lysate Test as End-Product Endotoxin Test for Human and Animal Parenteral Drugs, Biological Products, and Medical Devices

摘要

The guideline sets forth acceptable conditions for use of the Limulus Amebocyte Lysate test. It also describes procedures for using this methodology as an end-product endotoxin test for human injectable drugs (including biological products), animal injectable drugs, and medical devices. The procedures may be used in lieu of the rabbit pyrogen test. For the purpose of the guideline, the terms 'lysate' or 'lysate reagent' refer only to Limulus Amebocyte Lysate licensed by the Center for Biologic Evaluation and Research. The term 'official test' means that a test is referenced in a United States Pharmacopeia drug monograph, a New Drug Application or a Biological License.