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发明公开
CN104792892A 一种伊曲康唑2S,4R,2’S异构体中杂质含量测定方法 有权 转让

一种伊曲康唑2S,4R,2’S异构体中杂质含量测定方法
摘要：
本发明公布了一种伊曲康唑2S,4R,2’S异构体中杂质含量测定方法。伊曲康唑2S,4R,2’S异构体中杂质含量测定方法，以十八烷基硅烷键合硅胶为填充剂的色谱柱，以有机相和水相的混合溶剂作为流动相梯度洗脱，测定伊曲康唑2S,4R,2’S异构体合成过程中产生的杂质，检测方法科学、合理、准确、客观，从而能够更好的控制伊曲康唑2S,4R,2’S异构体的质量。
摘要（英）：

The invention discloses a testing method for the content of impurities in an itraconazole 2S,4R,2'S isomer. According to the testing method for the content of the impurities in the itraconazole 2S,4R,2'S isomer, octadecylsilane chemically bonded silica is used as a chromatographic column of a filling agent, organic phase and water phase mixed solvents are used as mobile phases to conduct gradient elution, the impurities generated in the synthesis process of the itraconazole 2S,4R,2'S isomer can be tested, and the testing method is scientific, reasonable, accurate and objective, so that the quality of the itraconazole 2S,4R,2'S isomer can be better controlled.

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