Study on Bacterial Endotoxin Test of Cytidine Disodium Triphosphate for Injection
Objective To establish a method for bacterial endotoxin test of Cytidine Disodium Triphosphate for Injection.Methods The bacterial endotoxin limit of Cytidine Disodium Triphosphate for Injection was strictly determined according to General Rule 1143 Bacterial Endotoxin Test Method listed in the Fourth Part of Chinese Pharmacopoeia(2020 Edition),and the methodology validation and bacterial endotoxin test were performed by the gel method.Results Four batches of test articles from two manufacturers at the concentration of 0.2 mg/ml did not interfere with the limulus test reagents from two manufacturers.The limit value of bacterial endotoxin was set as 2.5 EU/mg.The results of bacterial endotoxin test for four batches of Cytidine Disodium Triphosphate for Injection met the requirements.Conclusion The bacterial endotoxin test method established in this study can be used to substitute the rabbit pyrogen test and meet the quality control requirements of Cytidine Disodium Triphosphate for Injection.
Cytidine Disodium Triphosphate for Injectionbacterial endotoxingel methodinterference test
万方数据
维普
