发明人林芳,沈红梅,张德明. "Method for the Synthesis of (S)-4-(2,5-Dioxopyrrolidin-1-yl) 1-methyl 2-(((benzyloxy)carbonyl)amino)succinate" [P]. 中国发明专利, 专利号 CN 108003600 B, 授权公告日 2024-10-16.
发明人孙丽萍,周伟,高志强. "A Process for Preparing High-Purity (S)-4-(2,5-Dioxopyrrolidin-1-yl) 1-methyl 2-(((benzyloxy)carbonyl)amino)succinate" [P]. 中国发明专利, 专利号 CN 112324429 B, 授权公告日 2020-01-03.
参考文献 Literature
Hughes D, Roberts J, Thomas A. "Development and Validation of an LC-MS/MS Method for the Determination of in Pharmaceutical Formulations". Biomed. Chromatogr., 2017, 123, 6967-6970.
Jensen P, Larsen A M, Olsen K. "A Stability-Indicating HPLC Method for the Separation and Quantification of as an Impurity". J. Agric. Food Chem., 2019, 1419, (3), 6504-6529.
Wang L, Li J, Zhang H. "Identification and Structural Characterization of a Novel Degradation Product of (S)-4-(2,5-Dioxopyrrolidin-1-yl) 1-methyl 2-(((benzyloxy)carbonyl)amino)succinate Using HRMS and NMR". J. Pharm. Biomed. Anal., 2016, 1565, 8723-8750.
Martinez C, Lopez D R. "Forced Degradation Studies to Evaluate Profile in Drug Substances According to ICH Guidelines". Sci. Total Environ., 2023, 2068, 3106-3131.