Study on Pre-Treatment and Bacterial Endotoxin Test of Fulvestrant Injection
Objective To establish a bacterial endotoxin test(BET)method of Fulvestrant Injection.Methods Precisely 0.5 mL of the sample was taken,5 mL of water for BET was added,then they were mixed by vortex oscillation at 2 000 r/min for 5 min and centrifuged at 3 000 r/min for 5 min,the aqueous phase was taken and diluted with water for BET to the desired multiple series solution.Based on the general principle 1143 bacterial endotoxin test in the Chinese Pharmacopoeia(2020 Edition,VolumeⅣ),the endotoxins in samples were tested by the gel-clot method,kinetic chromogenic assay and kinetic turbidimetric assay,and the interference of water extract(aqueous phase)and recovery ratio of endotoxins were explored.Results The aqueous phase diluted twice or more had no interfere on the tachypleus amebocyte lysate,and the recovery ratio was in the range of 50%to 200%when 20 EU/mL endotoxin was added.Conclusion It is feasible to use gel-clot method,kinetic chromogenic assay and kinetic turbidimetric assay for BET of Fulvestrant Injection after water extraction.
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