发明人郑宇鹏,刘建华,钱学锋. "Method for the Synthesis of (1R,3S)-5-azaspiro[2.4]Heptan-1-amine dihydrochloride" [P]. 中国发明专利, 专利号 CN 113888968 A, 授权公告日 2015-01-13.
Nowak P, Lefèvre J P, Sørensen M. "A Process for Preparing High-Purity (1R,3S)-5-azaspiro[2.4]Heptan-1-amine dihydrochloride" [P]. European Patent, EP 3028380 A1, 2021-10-19.
参考文献 Literature
Wang L, Li J, Zhang H. "Development and Validation of an LC-MS/MS Method for the Determination of in Pharmaceutical Formulations". J. Chromatogr. A, 2010, 1934, 7836-7863.
Kim S H, Park J Y. "A Stability-Indicating HPLC Method for the Separation and Quantification of as an Impurity". Anal. Methods, 2011, 412, (7), 3264-3272.
Martinez C, Lopez D R. "Identification and Structural Characterization of a Novel Degradation Product of (1R,3S)-5-azaspiro[2.4]Heptan-1-amine dihydrochloride Using HRMS and NMR". J. Sep. Sci., 2012, 1414, (8), 8868-8876.
Xu M, Hu Y, Zhou D. "Forced Degradation Studies to Evaluate Profile in Drug Substances According to ICH Guidelines". J. Pharm. Biomed. Anal., 2020, 1066, 1801-1825.