细菌内毒素USP.docxVIP

BACTERIAL ENDOTOXINS TEST 85 USP35Portions of this general chapter have been harmonized with the corresponding texts of the?European Pharmacopoeia?and/or the?Japanese Pharmacopoeia. Those portions that are not harmonized are marked with symbols () to specify this fact.这一章节已经和欧洲药典（EP）与日本药典（JP）统一。没有统一的部分已经用标记出来。The Bacterial Endotoxins Test (BET) is a test to detect or quantify endotoxins from Gram-negative bacteria using amoebocyte lysate from the horseshoe crab (Limulus polyphemus?or?Tachypleus tridentatus).细菌内毒素检查法（BET）是通过鲎的阿米巴细胞溶解产物来检测或定量来自革兰氏阴性菌的内毒素。There are three techniques for this test: the gel-clot technique, which is based on gel formation; the turbidimetric technique, based on the development of turbidity after cleavage of an endogenous substrate; and the chromogenic technique, based on the development of color after cleavage of a synthetic peptide-chromogen complex. Proceed by any of the three techniques for the test. In the event of doubt or dispute, the final decision is made based upon the gel-clot technique unless otherwise indicated in the monograph for the product being tested. The test is carried out in a manner that avoids endotoxin contamination.细菌内毒素检查法有3种：凝胶法，基于凝胶的形成；浊度法，BACTERIAL ENDOTOXINS TEST USP32Portions of this general chapter have been harmonized with the corresponding texts of the European Pharmacopeia and/or the Japanese Pharmacopeia. Those portions that are not harmonized are marked with symbols () to specify this fact.This chapter provides a test to detect or quantify bacterial endotoxins that may be present in or on the sample of the article(s) to which the test is applied. It uses Limulus Amebocyte Lysate (LAL) obtained from the aqueous extracts of circulating amebocytes of horseshoe crab (Limulus polyphemus?or?Tachypleus tridentatus) which has been prepared and characterized for use as an LAL Reagent.1There are two types of techniques for this test: the gel-clot techniques, which are based on gel formation, and the photometric