多替拉韦钠有关物质的合成与表征

Synthesis and Characterization of Dolutegravir Sodium Related Substance

系统研究了多替拉韦钠合成工艺中的一系列关键工艺杂质和降解杂质,并对杂质的传递情况进行分析。通过实用的定向合成方法,简便高效地制备出纯度高于99%的杂质标准品,并进行全面的表征,为多替拉韦钠原料药的杂质研究和质量控制策略提供科学依据。

A series of key process impurities and degradation impurities in the synthesis process of dolutegravir sodium are systematically studied,and the transmission of impurities is analyzed.The impuritiy standards with purity higher than 99%are prepared easily and efficiently by a practical directional synthesis method,and are characterized comprehensively,thus providing a scientific basis for impurity research and quality control strategy of dolutegravir sodium API.