Establishment of bacterial endotoxin test for Dexamethasone Suspension for Intraocular Injection
HUANG Youxing
GAN Li
Abstract：Objective To establish and validate the bacterial endotoxin test method for Dexamethasone Suspension for Intraocular Injection.Methods According to Bacterial Endotoxin Test in Chinese Pharmacopoeia(2020 edition,Volume IV,1143),Dexamethasone Suspension for Intraocular Injection was dissolved by dimethylsulfoxide and diluted with bacterial endotoxin test water.Interference test and endotoxin recovery test were carried out with two manufacturers'gel tachypleus a-mebocyte lysate.Bacterial endotoxin test of the sample were performed too.Results There was no interference between bac-terial endotoxin and limulus reagent when Dexamethasone Suspension for Intraocular Injection was diluted 40 times.Dimeth-ylsulfoxide can be used for dissolving Dexamethasone Suspension for Intraocular Injection to perform bacterial endotoxin test.Conclusion Bacterial endotoxin test is suitable for the detection of Dexamethasone Suspension for Intraocular Injection.
Keywords：Dexamethasone Suspension for Intraocular InjectionBacterial endotoxinGel methodInterference test
Publication Date：2024-10-28
Online Publishing Date：2025-08-15(First online date of this platform, not the publication date of the document)
Pages：4( 968-971 )