title: Isolation and Structural Elucidation of an Unknown Impurity in Prasugrel by Semi-Preparative Liquid Chromatography.
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.
authors: College of Pharmaceutical Sciences, Zhejiang University, Hangzhou, Zhejiang Province, China Zhejiang Charioteer Pharmaceutical Co. Ltd., Tongyuanxi, Dazhan, Xinju County, Zhejiang Province, China.
authors: Chao
authors: C
authors: Liu
authors: Zhejiang Charioteer Pharmaceutical Co. Ltd., Tongyuanxi, Dazhan, Xinju County, Zhejiang Province, China.
authors: Zhangxin
authors: Z
authors: Yu
authors: Zhejiang Charioteer Pharmaceutical Co. Ltd., Tongyuanxi, Dazhan, Xinju County, Zhejiang Province, China.
authors: Fujun
authors: F
authors: Wang
authors: Zhejiang Charioteer Pharmaceutical Co. Ltd., Tongyuanxi, Dazhan, Xinju County, Zhejiang Province, China.
authors: Xing
authors: X
authors: Zhong
authors: Zhejiang Charioteer Pharmaceutical Co. Ltd., Tongyuanxi, Dazhan, Xinju County, Zhejiang Province, China.
authors: Li
authors: L
authors: Jiang
authors: Zhejiang Charioteer Pharmaceutical Co. Ltd., Tongyuanxi, Dazhan, Xinju County, Zhejiang Province, China.
authors: Feifei
authors: F
authors: Zhang
authors: Zhejiang Charioteer Pharmaceutical Co. Ltd., Tongyuanxi, Dazhan, Xinju County, Zhejiang Province, China.
authors: Yinxia
authors: Y
authors: Tang
authors: Zhejiang Charioteer Pharmaceutical Co. Ltd., Tongyuanxi, Dazhan, Xinju County, Zhejiang Province, China.
authors: Zhaohua
authors: Z
authors: Yan
authors: College of Pharmaceutical Sciences, Zhejiang University, Hangzhou, Zhejiang Province, China.
authors: Su
authors: S
authors: Zeng
authors: Zhejiang Charioteer Pharmaceutical Co. Ltd., Tongyuanxi, Dazhan, Xinju County, Zhejiang Province, China putong@charioteer.cn.
authors: Tong
authors: T
authors: Pu
mesh_terms: D002851:Chromatography, High Pressure Liquid / Q000379:methods; D056148:Chromatography, Reverse-Phase / Q000379:methods; D004340:Drug Contamination; D009682:Magnetic Resonance Spectroscopy / Q000379:methods; D010975:Platelet Aggregation Inhibitors / Q000737:chemistry* / Q000302:isolation & purification; D000068799:Prasugrel Hydrochloride / Q000737:chemistry* / Q000302:isolation & purification
chemical_list: D010975:Platelet Aggregation Inhibitors; D000068799:Prasugrel Hydrochloride