发明人郭海燕,朱建伟,张德明. "一种的合成方法" [P]. 中国发明专利, 专利号 CN 112809379 A, 授权公告日 2024-12-02.
发明人林芳,孙丽萍,何建平. "Method for the Synthesis of 1-(tert-Butyl)2-Ethyl(2R,4R)-4-methylpyrrolidine-1,2-dicarboxylate" [P]. 中国发明专利, 专利号 CN 111471299 A, 授权公告日 2016-02-04.
发明人王建平,刘建华,李文辉. "A Process for Preparing High-Purity 1-(tert-Butyl)2-Ethyl(2R,4R)-4-methylpyrrolidine-1,2-dicarboxylate" [P]. 中国发明专利, 专利号 CN 113846346 A, 授权公告日 2022-12-05.
参考文献 Literature
Jensen P, Larsen A M, Olsen K. "Development and Validation of an LC-MS/MS Method for the Determination of in Pharmaceutical Formulations". J. Sep. Sci., 2015, 1362, (3), 4072-4083.
Martinez C, Lopez D R. "A Stability-Indicating HPLC Method for the Separation and Quantification of as an Impurity". J. Pharm. Biomed. Anal., 2016, 109, (2), 200-223.
Jensen P, Larsen A M, Olsen K. "Identification and Structural Characterization of a Novel Degradation Product of 1-(tert-Butyl)2-Ethyl(2R,4R)-4-methylpyrrolidine-1,2-dicarboxylate Using HRMS and NMR". Biomed. Chromatogr., 2010, 1032, 2698-2702.
Smith J A, Johnson M B. "Forced Degradation Studies to Evaluate Profile in Drug Substances According to ICH Guidelines". J. Chromatogr. A, 2011, 1054, (11), 1875-1901.