为了提高雷美替胺药品的质量,结合已报道的合成工艺路线,针对其关键的还原工序,设计并定向合成了3种雷美替胺的杂质Imp1、Imp2和Imp3,所有杂质均通过1HNMR、13CNMR和MS确证了结构.所合成的杂质可作为对照品,为雷美替胺合成工艺优化、分析方法开发和质量研究提供一定的帮助.
In order to improve the quality of ramelteon drug,three impurities Imp1,Imp2 and Imp3 of ramelteon were designed and synthesized according to the reported synthesis process and the key reduction process.The chemical structures of the impurities were confirmed by 1HNMR,13CNMR and MS.These impurities can be used as reference materials to promote the synthesis process optimization,analytical method development and quality research of ramelteon drug.