883555-07-5Relevant articles and documents
Synthesis method of process impurity of amisulpride
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Paragraph 0012-0013, (2021/07/09)
The invention discloses a synthesis method of a process impurity of amisulpride, and belongs to the technical field of chemical pharmacy. N-ethyl-2-aminomethylpyrrolidine (2) reacts with (BOC)2O to obtain 1-ethyl pyrrolidine-2-methyl tert-butyl carbamate (3); CH3I is added under the alkaline condition of NaH, and methylation is performed to obtain N-(1-ethyl pyrrolidine-2-methyl), N-methyl tert-Butyl carbamate (4); under an acidic condition, hydrolysis is carried out to obtain N-ethyl-2-methylaminomethylpyrrolidine (5); and finally reaction with 4-amino-5-(ethylsulfonyl)-2-methoxybenzoic acid (6) is performed under the catalysis of theorganic alkali N',N-carbonyldiimidazole (CDI) to obtain an amisulpride impurity (1). The synthesized high-purity amisulpride impurity is used as an impurity standard substance in detection and analysis ofamisulpride finished products, so that the positioning accuracy of the amisulpride impurity is improved; control on impurities is enhanced, and the purpose of controlling the quality of the finished amisulpride is finally achieved; and the raw materials are simple and easy to obtain, and operation is simple.