Pretreatment of torasemide and bacterial endotoxin test methods research

VernacularTitle:托拉塞米原料药前处理及细菌内毒素检查方法研究
Author: Yuhuan MO ¹ ; Xian HUANG ¹
Author Information

1. 广西壮族自治区药品检验研究院,南宁 530021
Publication Type:Journal Article
Keywords: torasemide; bacterial endotoxin; DMSO; gel method; dynamic chromogenic method; dynamic turbidity method
From: Drug Standards of China 2024;25(6):600-606
CountryChina
Language:Chinese
Abstract: Objective:To establish a bacterial endotoxin test method for torasemide.Methods:Torasemide was dissolved in dimethyl sulfoxide(DMSO),and then diluted with bacterial endotoxin test water(BET water).According to the bacterial endotoxin test method of general rule 1143 in the fourth part of the 2020 edition of the"Pharmacopoeia of the People's Republic of China,"the endotoxin in the sample was detected by gel method,dy-namic turbidity method and dynamic chromogenic method,respectively.The interference of torasemide solution and the recovery ratio of endotoxin were investigated.Results:After the sample was dissolved in DMSO and diluted with BET water,there was no precipitation.The interference test of gel method,dynamic chromogenic method and dynamic turbidity method met the requirements and could be excluded.Conclusion:After dissolution of torasemide by DMSO,it is feasible to use gel method,dynamic turbidimetric method and dynamic chromogenic method for bacterial endotoxin test.