20619-12-9Relevant academic research and scientific papers
Preparation method of chlorpheniramine maleate impurities
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Paragraph 0030; 0033-0034; 0037-0038; 0041, (2021/04/26)
The invention relates to the technical field of pharmaceutical and chemical quality control, in particular to a preparation method of chlorpheniramine maleate impurities. The preparation method of the chlorpheniramine maleate impurity comprises the following steps: (1) reacting a compound 1 with N-(tert-butyloxycarbonyl)-2-chloroethylamine under an alkaline condition and under the action of a phase transfer catalyst to obtain a compound 2; and (2) reacting the compound 2 with a reducing agent to obtain the chlorpheniramine maleate impurities. The preparation method provided by the invention can be used for directionally synthesizing the European pharmacopoeia EP impurity C in chlorpheniramine maleate, is simple, convenient and feasible in process operation, has the advantages of high yield, high purity, short reaction time and the like, solves the problem of shortage of impurity reference substances, and is more beneficial to quality control on a chlorpheniramine maleate crude drug finished product.
