EP5.1.10细菌内毒素测试使用指南(中英文11)技术方案.docVIP

EP5.1.10 细菌内毒素测试使用指南（中英文1/2）?? 2015-12-28 22:58:13|??分类：?EP 07/2016: 50110 5.1.10. GUIDELINES FOR USING THE TEST FOR BACTERIAL ENDOTOXINS 1. INTRODUCTION?概述 Endotoxins from gram-negative bacteria are the most common cause of toxic reactions resulting from contamination of pharmaceutical products with pyrogens; their common pyrogenic activity is much higher than that of other known pyrogenic substances. These endotoxins are lipopolysaccharides. Although there are a small number of pyrogens that possess a different structure, the conclusion is generally justified that the absence of bacterial en