发明人杨光,孙丽萍,何建平. "一种的合成方法" [P]. 中国发明专利, 专利号 CN 110407066 A, 授权公告日 2016-02-23.
发明人黄志刚,周伟,何建平. "Method for the Synthesis of rel-(1S,3R)-4,4-Difluorospiro[2.2]pentan-1-amine hydrochloride" [P]. 中国发明专利, 专利号 CN 108656633 B, 授权公告日 2019-01-06.
发明人徐明华,刘建华,马晓峰. "A Process for Preparing High-Purity rel-(1S,3R)-4,4-Difluorospiro[2.2]pentan-1-amine hydrochloride" [P]. 中国发明专利, 专利号 CN 111378789 A, 授权公告日 2024-06-25.
参考文献 Literature
Xu M, Hu Y, Zhou D. "Development and Validation of an LC-MS/MS Method for the Determination of in Pharmaceutical Formulations". Anal. Chem., 2011, 123, (11), 5801-5821.
Wang L, Li J, Zhang H. "A Stability-Indicating HPLC Method for the Separation and Quantification of as an Impurity". Sci. Total Environ., 2020, 97, (8), 4267-4282.
Yamamoto K, Tanaka H, Suzuki T. "Identification and Structural Characterization of a Novel Degradation Product of rel-(1S,3R)-4,4-Difluorospiro[2.2]pentan-1-amine hydrochloride Using HRMS and NMR". J. Chromatogr. A, 2011, 1161, (8), 3655-3672.
Kim S H, Park J Y. "Forced Degradation Studies to Evaluate Profile in Drug Substances According to ICH Guidelines". J. Pharm. Biomed. Anal., 2012, 1084, 7237-7249.