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Isolation and Structural Elucidation of an Unknown Impurity in Prasugrel by Semi-Preparative Liquid Chromatography
Chao Liu1, Zhangxin Yu2, Fujun Wang2
1College of Pharmaceutical Sciences, Zhejiang University, Hangzhou, Zhejiang Province, China Zhejiang Charioteer Pharmaceutical Co. Ltd., Tongyuanxi, Dazhan, Xinju County, Zhejiang Province, China.
Abstract:
A brand-new impurity was detected by RP-HPLC in the prasugrel. The impurity was named as Impurity X. Impurity X was isolated by using semi-preparative HPLC followed by characterization using nuclear magnetic resonance spectroscopy and liquid chromatography-mass spectrometry. The functional mechanism of Impurity X was speculated. Impurity X could be controlled in the manufacture process of the prasugrel active pharmaceutical ingredient effectively.
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