发明人周伟,黄志刚,高志强. "Method for the Synthesis of 3-(3,5-Dimethoxyphenyl)-8-methyl-1,4-diazaspiro[4.5]Dec-3-ene-2-thione" [P]. 中国发明专利, 专利号 CN 114594822 A, 授权公告日 2022-05-18.
Roberts E F, Hughes D C, Davis P L. "A Process for Preparing High-Purity 3-(3,5-Dimethoxyphenyl)-8-methyl-1,4-diazaspiro[4.5]Dec-3-ene-2-thione" [P]. US Patent, US 10366763 B2, 2019-03-28.
参考文献 Literature
Mueller T, Schmidt R K. "Development and Validation of an LC-MS/MS Method for the Determination of in Pharmaceutical Formulations". Anal. Chem., 2010, 828, (5), 5440-5462.
Garcia M, Rodriguez P. "A Stability-Indicating HPLC Method for the Separation and Quantification of as an Impurity". J. Pharm. Biomed. Anal., 2011, 2128, (2), 460-471.
Fischer P, Wagner E. "Identification and Structural Characterization of a Novel Degradation Product of 3-(3,5-Dimethoxyphenyl)-8-methyl-1,4-diazaspiro[4.5]Dec-3-ene-2-thione Using HRMS and NMR". Environ. Sci. Technol., 2017, 1597, (12), 9273-9289.
Xu M, Hu Y, Zhou D. "Forced Degradation Studies to Evaluate Profile in Drug Substances According to ICH Guidelines". Food Chem., 2015, 1392, (6), 8505-8530.