Determination of Bacterial Endotoxin by the Micro-Gel Method
Objective To establish a micro-gel method for the determination of bacterial endotoxin in samples.Methods Test was conducted according to 1143 bacterial endotoxin test method in the China Pharmacopoeia(2020 Edition,Volume Ⅳ),the tube diameter(4,8 mm)and sample volume(0,20,30,40,50,60,70 µL)suitable for the test were determined through pre-test,and then the sensitivity check test of tachypleus amebocyte lysate(TAL)and the bacterial endotoxin test of samples were conducted and compared with the current gel method collected in the China Pharmacopoeia.Results The pre-test results showed that the flat glass test tube with the inner diameter of 8 mm and the sample volume of 40 µL or 50 µL were determined to be used for the micro-gel method.The sensitivity check test of TAL was conducted and the sensitivity check result of micro-gel method was consistent with the current gel method in the China Pharmacopoeia,and they were within the acceptable range of sensitivity.The bacterial endotoxin test of samples was conducted,and the result of the micro-gel method test was consistent with the current gel method in the China Pharmacopoeia.Conclusion The micro-gel method can be used as a supplement or alternative to the current gel method in the China Pharmacopoeia,which can be used for the bacterial endotoxin test of sterilized preparations in the absence of TAL.
micro-gel methodbacterial endotoxin testtachypleus amebocyte lysatesupplemental or alternative method
万方数据
维普
