发明人郭海燕,徐明华,韩伟. "Method for the Synthesis of (S)-2-Amino-1-((R)-3-(isopropyl(methyl)amino)piperidin-1-yl)-3-methylbutan-1-one" [P]. 中国发明专利, 专利号 CN 111604665 A, 授权公告日 2017-03-14.
发明人高志强,马晓峰,沈红梅. "A Process for Preparing High-Purity (S)-2-Amino-1-((R)-3-(isopropyl(methyl)amino)piperidin-1-yl)-3-methylbutan-1-one" [P]. 中国发明专利, 专利号 CN 108756522 B, 授权公告日 2020-03-05.
参考文献 Literature
Zhou X P, Huang L, Wu G. "Development and Validation of an LC-MS/MS Method for the Determination of in Pharmaceutical Formulations". J. Agric. Food Chem., 2018, 512, (3), 4278-4299.
Lee J H, Choi Y S. "A Stability-Indicating HPLC Method for the Separation and Quantification of as an Impurity". J. Sep. Sci., 2021, 1211, 2724-2738.
Jensen P, Larsen A M, Olsen K. "Identification and Structural Characterization of a Novel Degradation Product of (S)-2-Amino-1-((R)-3-(isopropyl(methyl)amino)piperidin-1-yl)-3-methylbutan-1-one Using HRMS and NMR". Biomed. Chromatogr., 2018, 502, 8435-8447.
Kim S H, Park J Y. "Forced Degradation Studies to Evaluate Profile in Drug Substances According to ICH Guidelines". Anal. Methods, 2010, 340, (7), 2875-2883.