Zhejiang Charioteer Pharmaceutical Co. Ltd.

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.

The effective component of gemcitabine is β configuration, which produces β and α configurations in the process of synthesis.The β configuration of the product is obtained by separating the two configurations, and the other α configuration is racemized and then separated to obtain the β configuration, which reduces the cost and is more beneficial to industrialization.

2-Amino-3-methylpyridine was prepared from 3-methylpyridine and NaNH₂ by a Chichibabin amination reaction, formation of an intermediate salt, hydrolysis of that salt and product formation (80% overall yield).