头孢妥仑匹酯有关物质的合成及其结构确证

Synthesis and structure identification of related substances from cefditoren pivoxil

目的根据美国药典公布的头孢妥仑匹酯的杂质谱,合成3个杂质,并对其进行结构确证,为质量研究提供参考。方法通过化学法合成,运用NMR、HRMS进行结构解析。结果合成了目标化合物,并运用HMR、HRMS对3个杂质碳氢信号进行了归属和详解。结论杂质的合成及其结构的详解为头孢妥仑匹酯的杂质研究和质量控制提供了参考。

Objective According to the impurity profile of cefditoren pivoxil released by the USP,three impurities were synthesized and structurally confirmed,providing a reference for the quality research.Methods Synthesis of the impurities by using chemical methods and structural analysis by using NMR and HRMS data.Results The target compounds are synthesized and the 1H NMR and 13C NMR chemical signals were assigned and interpreted by HMR and HRMS.Conclusion The synthesis of impurities and the detailed solution of its structure provide the reference for the impurity study and the quality control of cefditoren pivoxil.