Discussion on the use and preservation methods of control standard endotoxin
WANG Li
GOU Zhimei
BAI Chunyun
WANG Ying
Abstract：Objective To study the use and preservation methods of control standard endotoxin(CSE),in order to rea-sonable and economical use it,and reduce waste.Methods According to the Appendix of China Pharmacopoeia in 2020 Vol Ⅲ 1143"Bacterial endotoxins test"and"Test for confirmation of labeled lysate sensitivity",dissolve and store the con-trol standard endotoxin solution at 4 ℃.Then take the test of labeled lysate sensitivity at different storage times and compare the changes in the results of it.Measure the reaction time of endpoint at the same concentration but different storage times with turbidimetric technique at the same time,and compare the changes in the reaction time.Results Control standard en-dotoxin solution can be used for gel-clot technique within 9 days when it is stored at 4 ℃,and there is no statistical signifi-cance in turbidimetric technique reaction time of endpoint within 7 days.Conclusion Control standard endotoxin produced and calibrated by NIFDC can be used for 7 days after it is dissolved and stored at 4 ℃.
Keywords：Control standard endotoxin(CSE)Storage timeStability
Publication Date：2025-03-30
Online Publishing Date：2025-08-15(First online date of this platform, not the publication date of the document)
Pages：4( 253-256 )