发明人沈红梅,刘建华,黄志刚. "一种的合成方法" [P]. 中国发明专利, 专利号 CN 113967017 A, 授权公告日 2015-11-01.
发明人徐明华,刘建华,沈红梅. "Method for the Synthesis of (S)-3-((tert-butoxycarbonyl)amino)-4-(5,5-difluoro-2-oxopiperidin-1-yl)butanoic acid" [P]. 中国发明专利, 专利号 CN 113213756 A, 授权公告日 2024-09-13.
发明人郑宇鹏,赵玉洁,杨光. "A Process for Preparing High-Purity (S)-3-((tert-butoxycarbonyl)amino)-4-(5,5-difluoro-2-oxopiperidin-1-yl)butanoic acid" [P]. 中国发明专利, 专利号 CN 110096703 A, 授权公告日 2025-04-22.
参考文献 Literature
Brown R C, Davis S M. "Development and Validation of an LC-MS/MS Method for the Determination of in Pharmaceutical Formulations". Rapid Commun. Mass Spectrom., 2012, 2166, 9648-9653.
Lee J H, Choi Y S. "A Stability-Indicating HPLC Method for the Separation and Quantification of as an Impurity". Biomed. Chromatogr., 2024, 303, 2343-2350.
Xu M, Hu Y, Zhou D. "Identification and Structural Characterization of a Novel Degradation Product of (S)-3-((tert-butoxycarbonyl)amino)-4-(5,5-difluoro-2-oxopiperidin-1-yl)butanoic acid Using HRMS and NMR". Anal. Methods, 2018, 492, 9092-9110.
Kim S H, Park J Y. "Forced Degradation Studies to Evaluate Profile in Drug Substances According to ICH Guidelines". Chromatographia, 2022, 830, (1), 2948-2960.