Establish the method of bacterial endotoxins test for human papillomavirus bivalent(types 16,18)vaccine(pichia pastoris)
Objective Establish the method of bacterial endotoxins test for human papillomavirus bivalent(types 16,18)vaccine(pichia pastoris).Methods The method of gel-clot technique and photometric technique(kinetic-turbidimetric assay and kinetic-chromogenic assay)for the determination of bacterial endotoxins was carried out according to the Appendix of China Pharmacopoeia in 2020 Vol Ⅲ 1143"bacterial endotoxins test"and Vol IV 9251"guidelines for bacterial endotoxin test".Results There is no interference after more than forty times dilution for gel-clot technique,the recovery rates of kinetic-turbidimetric assay and kinetic-chromogenic assay can also meet the requirements.Conclusion It is feasible to establish gel-clot technique,kinetic-turbidimetric assay and kinetic-chromogenic assay for bacterial endotoxin test of human papillomavirus bivalent(types 16,18)vaccine(pichia pastoris).
Human papillomavirus bivalent(types16,18)vaccine(pichia pastoris)Bacterial endotoxins testGel-clot techniquePhotometric techniqueKinetic-turbidimetric assayKinetic-chromogenic assay
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维普
