Determination of Bacterial Endotoxin in Fat Emulsion(10%)/Amino Acid (15)/Glucose (20%) Injection by Gel Method

VernacularTitle:凝胶法测定脂肪乳(10%)/氨基酸(15)/葡萄糖(20%)注射液中的细菌内毒素
Author: Wenjia WANG ; Zhiming CHEN ; Namin ZHANG ; Mengying ZHOU ; Huahong HE ; Wei LI
Keywords: Fat emulsion (10％)/amino acid (15)/glucose (20％) injection; Bacterial endotoxin test; Gel method; Interfer-ence test; Chromogenic method
From: China Pharmacy 2017;28(18):2576-2578
CountryChina
Language:Chinese
Abstract: OBJECTIVE:To adopt gel method for the determination of bacterial endotoxin in Fat emulsion(10%)/amino acid (15)/glucose (20%) injection. METHODS:According to the gel method in term ofbacterial endotoxin test methodin Chinese Pharmacopeia(2015 edition),the maximal valid dilution(MVD)of samples were determined through interference test and the vali-dated. The results were compared with chromogenic method. RESULTS:In gel method,the interference to agglutination reaction of TAL and bacterial endotoxin can be excluded when samples were diluted 24 times or less. In chromogenic method,the samples should be diluted 76 times or less. CONCLUSIONS:Gel method can be used for bacterial endotoxin test of Fat emulsion(10%)/amino acid(15)/glucose(20%)injection.