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甜菜安原药主要杂质成因及其控制方法研究

     

摘要

The process for manufacture of desmedipham is usually known via two-step method by using m-aminophenol,ethyl chloroformate and phenyl isocyanate as starting materials.In this paper,4 main impurities from desmedipham technical were structurally identified by HPLC-MS analysis data combined with reasonable speculation according to its manufacturing process,described the chemical formation processes of those impurities in the technical production,and thus proposed the improvements for the individual process so as to control & minimize the formation of each impurity.%甜菜安的生产工艺通常是以间氨基苯酚、氯甲酸乙酯和苯基异氰酸酯为主要原料经2步法合成.利用HPLC-MS分析并结合对生产工艺的合理推测,确定了甜菜安原药中4个主要杂质的化学结构,分析了其化学成因,提出了通过优化工艺过程控制这些杂质的方法.

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