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).

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