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发明公开
CN107857795A 甘氨酰谷氨酰胺杂质的制备方法 无效 - 驳回

甘氨酰谷氨酰胺杂质的制备方法
摘要：
本发明涉及一种甘氨酰谷氨酰胺杂质的制备方法，属于医药合成技术领域。所述的制备方法，具体步骤如下：(1)N-Pht-甘氨酸的制备；(2)N-Pht-甘氨酰氯的制备；(3)N-Pht-甘氨酰甘氨酰-L-谷氨酰胺的制备；(4)甘氨酰甘氨酰-L-谷氨酰胺的制备。本发明提供了一种甘氨酰谷氨酰胺原料药中杂质甘氨酰甘氨酰-L-谷氨酰胺的制备方法，该路线设计合理，操作简单，反应条件温和，原料易得，所得杂质纯度达99％以上，能够作为甘氨酰谷氨酰胺杂质研究的对照品使用，用于杂质的定性定量分析，对甘氨酰谷氨酰胺原料药质量研究有积极意义。
摘要（英）：

The invention relates to a preparation method of glycyl glutamine impurity, and belongs to the technical field of medicine synthesis. The preparation method specifically comprises the following stepsof (1) preparing N-Pht-glycine; (2) preparing N-Pht-glycyl chloride; (3) preparing N-Pht-glycyl glycyl-L-glutamine; (4) preparing glycyl glycyl-L-glutamine. The preparation method of the glycyl glutamine impurity glycyl glycyl-L-glutamine in crude drug is provided and has the advantages that the route design is reasonable, the operation is simple, the reaction conditions are moderate, the obtaining of raw materials is easy, and the purity of the prepared impurity reaches 99% or above; the impurity can be used as a contrast product for studying the glycyl glutamine impurity, the impurity can bequalitatively and quantitatively analyzed, and the positive meaning is realized for the study of the quality of the crude drug of glycyl glutamine.

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