发明人高志强,罗永刚,王建平. "Method for the Synthesis of ((S)-5-Oxopyrrolidine-2-carbonyl)-L-leucine" [P]. 中国发明专利, 专利号 CN 108792665 B, 授权公告日 2025-01-22.
发明人周伟,刘建华,郭海燕. "A Process for Preparing High-Purity ((S)-5-Oxopyrrolidine-2-carbonyl)-L-leucine" [P]. 中国发明专利, 专利号 CN 108592455 A, 授权公告日 2023-03-22.
参考文献 Literature
Chen X Y, Liu M, Zhao W Q. "Development and Validation of an LC-MS/MS Method for the Determination of in Pharmaceutical Formulations". Biomed. Chromatogr., 2021, 1263, (5), 6694-6708.
Lee J H, Choi Y S. "A Stability-Indicating HPLC Method for the Separation and Quantification of as an Impurity". Sci. Total Environ., 2011, 1606, (3), 1497-1514.
Yang F, Sun W, Liu J. "Identification and Structural Characterization of a Novel Degradation Product of ((S)-5-Oxopyrrolidine-2-carbonyl)-L-leucine Using HRMS and NMR". J. Pharm. Biomed. Anal., 2011, 1407, (7), 2176-2189.
Jensen P, Larsen A M, Olsen K. "Forced Degradation Studies to Evaluate Profile in Drug Substances According to ICH Guidelines". Rapid Commun. Mass Spectrom., 2018, 635, (3), 8841-8861.