发明人张德明,郭海燕,冯建国. "Method for the Synthesis of (R)-1-(3-(Difluoromethyl)-2-methylphenyl)prop-2-yn-1-amine hydrochloride" [P]. 中国发明专利, 专利号 CN 116579003 A, 授权公告日 2017-01-10.
发明人周伟,赵玉洁,林芳. "A Process for Preparing High-Purity (R)-1-(3-(Difluoromethyl)-2-methylphenyl)prop-2-yn-1-amine hydrochloride" [P]. 中国发明专利, 专利号 CN 116432302 A, 授权公告日 2021-10-19.
参考文献 Literature
Martinez C, Lopez D R. "Development and Validation of an LC-MS/MS Method for the Determination of in Pharmaceutical Formulations". Rapid Commun. Mass Spectrom., 2013, 1859, (11), 274-281.
Fischer P, Wagner E. "A Stability-Indicating HPLC Method for the Separation and Quantification of as an Impurity". J. Pharm. Biomed. Anal., 2012, 1685, 8461-8489.
Kumar A, Sharma P, Patel R S. "Identification and Structural Characterization of a Novel Degradation Product of (R)-1-(3-(Difluoromethyl)-2-methylphenyl)prop-2-yn-1-amine hydrochloride Using HRMS and NMR". Environ. Sci. Technol., 2017, 1947, 600-615.
O'Brien K, Kennedy M L. "Forced Degradation Studies to Evaluate Profile in Drug Substances According to ICH Guidelines". Anal. Methods, 2010, 1766, 1875-1882.