Methods for Bacterial Endotoxin Test of Zoledronic Acid
Objective:lo establish a method for bacterial endotoxin test of zoledronic acid raw material.Methods:lhe detection limit of bacterial endotoxin of zoledronic acid raw material was established according to Appendix 1143 of Chinese Pharmacopoeia(Ⅳ)2020 edition.Results:Zoledronic acid had no interference with bacterial endotoxin test when the concentration was 0.05 mg/mL or less.Conclusion:The bacterial endotoxin limit of zoledronic acid raw material can be set to 10 EU/g.
zoledronic acidbacterial endotoxintachypleus amebocyte lysateinterference test
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