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目的:对合成的唑来膦酸中残留有机溶剂检查研究。方法:根据新药审评的技术要求,对合成唑来磷酸生产过程中引入的有害有机溶剂氯苯、二氯甲烷、丙酮进行检查。结果:确定了残留有机溶剂测定方法。结论:该方法可有效用于合成的唑来膦酸中残留有机溶剂质量控制。
Objective: To study the residual organic solvent in the synthesized zoledronic acid. Methods: According to the technical requirements of the new drug review, the harmful organic solvents chlorobenzene, methylene chloride and acetone introduced during the synthesis of zoledronic acid were examined. Results: The residual organic solvent was determined. Conclusion: This method is effective for the quality control of residual organic solvents in the synthesized zoledronic acid.