Rivaroxaban related substance preparation method

The invention discloses a rivaroxaban related substance A preparation method. The method comprises the following steps: rivaroxaban is hydrolyzed and subjected to a ring opening reaction to obtain a compound A under action of inorganic base. The method firstly designs and synthesizes the rivaroxaban...

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1. Verfasser: SONG XUEPAN
Format: Patent
Sprache:chi ; eng
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Zusammenfassung:The invention discloses a rivaroxaban related substance A preparation method. The method comprises the following steps: rivaroxaban is hydrolyzed and subjected to a ring opening reaction to obtain a compound A under action of inorganic base. The method firstly designs and synthesizes the rivaroxaban related substance A which can be used as a reference material for qualitative and quantitative research on impurities in rivaroxaban quality research, and the content of the related substance in the bulk drug is controlled to ensure the quality of the bulk drug. The preparation method provided by the invention has the advantages of high yield, high purity, mild reaction condition, and easy operation, and is suitable industrial production. 本发明公开了种利伐沙班有关物质A的制备方法,包括如下步骤:在无机碱作用下,利伐沙班水解开环反应得到化合物A。本发明首次定向设计并合成利伐沙班有关物质A,其可作为对照品供利伐沙班质量研究中杂质的定性定量研究使用,控制原料药中有关物质的含量,保证原料药的质量;且本发明提供的制备方法,产率较高、纯度高、反应条件温和,易于操作,适宜工业化生产。