【摘要】 为解决国内缺少阿奇霉素杂质对照品的现状,加强阿奇霉素的质量控制,通过化学合成或半制备液相色谱分离的方法制备了红霉素A 6,9-亚胺醚,红霉素A 9,11-亚胺醚,3-去克拉定糖阿奇霉素,3′-N-去甲基阿奇霉素,3′-N-去甲基-3′-N-对-乙酰胺基苯磺酰基阿奇霉素和阿奇霉素B 6种杂质的纯品.经过核磁共振、质谱等手段确认各化合物结构正确;并从生产工艺出发详细分析了各杂质的来源和可行的控制方法.更多还原

【Abstract】 Six compounds were made by chemical synthesis or semi-preparative HPLC separation for azithromycin to promote quality and impurity control.They are erythromycin A 6,9-imino ether,erythromycin A 9,11-imino ether,3′-N-demethyl azithromycin,3′-N-[[4-(acetylamino) phenyl] sulphonyl]-3′-N-demethyl azithromycin, 3-decladinosylazithromycin and 12-dedeoxyazithromycin(azithromycin B),which were obtained through chemical synthesis or semipreparative HPLC separation.Their structures are identified by MS,1 H NMR and 13C NMR. The source and control methods of these impurities are also presented to improve azithromycin production process.更多还原