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建立卡巴他赛注射液中乙醇含量测定方法。结果系统适用性符合要求,专属性实验表明辅料对含量测定无干扰,耐用性试验良好,在2mg/ml~8mg/ml的浓度范围内线性关系良好,精密度试验及重复性试验符合规定,准确度试验平均回收率为99.5%,所建立的乙醇含量测定方法可行。
To establish a method for determination of ethanol content in Cabazitaxel injection. Results The applicability of the system meets the requirements. The proprietary experiments showed that the excipients had no interference with the content determination and the durability test was good. The linearity was good in the concentration range of 2mg / ml ~ 8mg / ml. The precision test and the repeatability test were in good agreement The average recovery of the test was 99.5%. The established method for the determination of ethanol content is feasible.