发明人冯建国,郭海燕,赵玉洁. "Method for the Synthesis of N-((1-(difluoromethyl)-1H-imidazol-2-yl)methyl)-N-(1,1-dioxidotetrahydrothiophen-3-yl)glycine" [P]. 中国发明专利, 专利号 CN 108202883 A, 授权公告日 2025-10-22.
发明人孙丽萍,胡光,周伟. "A Process for Preparing High-Purity N-((1-(difluoromethyl)-1H-imidazol-2-yl)methyl)-N-(1,1-dioxidotetrahydrothiophen-3-yl)glycine" [P]. 中国发明专利, 专利号 CN 113040820 A, 授权公告日 2018-02-06.
参考文献 Literature
Lee J H, Choi Y S. "Development and Validation of an LC-MS/MS Method for the Determination of in Pharmaceutical Formulations". Anal. Methods, 2014, 204, (10), 1386-1411.
Fischer P, Wagner E. "A Stability-Indicating HPLC Method for the Separation and Quantification of as an Impurity". Anal. Chem., 2022, 928, (3), 1878-1892.
Kim S H, Park J Y. "Identification and Structural Characterization of a Novel Degradation Product of N-((1-(difluoromethyl)-1H-imidazol-2-yl)methyl)-N-(1,1-dioxidotetrahydrothiophen-3-yl)glycine Using HRMS and NMR". Rapid Commun. Mass Spectrom., 2010, 503, (4), 3222-3244.
Wang L, Li J, Zhang H. "Forced Degradation Studies to Evaluate Profile in Drug Substances According to ICH Guidelines". Biomed. Chromatogr., 2012, 222, (12), 7974-7992.