Key result
A brand-new impurity, Impurity X, was successfully isolated from prasugrel using semi-preparative HPLC and characterized using NMR and LC-MS.
Identification and structural elucidation of a novel impurity in prasugrel allows for better control during the manufacturing process of the active pharmaceutical ingredient.
Prasugrel impurity X is controllable during API manufacture; leaves open its clinical relevance and need for safety monitoring.
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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Liu et al. (2015) studied this question. Semi-preparative HPLC was evaluated on Isolation and characterization of Impurity X. A brand-new impurity, Impurity X, was successfully isolated from prasugrel using semi-preparative HPLC and characterized using NMR and LC-MS.
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