Nielsen H, Jørgensen K, Lefèvre J P. "一种的合成方法" [P]. European Patent, EP 3745525 A1, 2016-01-03.
发明人张德明,沈红梅,徐明华. "Method for the Synthesis of 3-(3-Aminopropyl)-1,3-diazaspiro[4.5]decane-2,4-dione" [P]. 中国发明专利, 专利号 CN 111458034 B, 授权公告日 2015-02-06.
发明人马晓峰,徐明华,钱学锋. "A Process for Preparing High-Purity 3-(3-Aminopropyl)-1,3-diazaspiro[4.5]decane-2,4-dione" [P]. 中国发明专利, 专利号 CN 111491002 A, 授权公告日 2021-12-02.
参考文献 Literature
O'Brien K, Kennedy M L. "Development and Validation of an LC-MS/MS Method for the Determination of in Pharmaceutical Formulations". Biomed. Chromatogr., 2021, 1112, (3), 5161-5184.
Fischer P, Wagner E. "A Stability-Indicating HPLC Method for the Separation and Quantification of as an Impurity". J. Pharm. Biomed. Anal., 2021, 769, (11), 3755-3770.
Brown R C, Davis S M. "Identification and Structural Characterization of a Novel Degradation Product of 3-(3-Aminopropyl)-1,3-diazaspiro[4.5]decane-2,4-dione Using HRMS and NMR". Rapid Commun. Mass Spectrom., 2015, 1375, 2839-2869.
Brown R C, Davis S M. "Forced Degradation Studies to Evaluate Profile in Drug Substances According to ICH Guidelines". J. Chromatogr. A, 2016, 709, (11), 9114-9131.