发明人罗永刚,郭海燕,张德明. "Method for the Synthesis of 5-Chloro-N-(2,4-difluorophenyl)-2-oxo-1-(4-(trifluoromethyl)benzyl)-1,2-dihydropyridine-3-carboxamide" [P]. 中国发明专利, 专利号 CN 116867505 B, 授权公告日 2021-04-24.
发明人郑宇鹏,李文辉,陈志强. "A Process for Preparing High-Purity 5-Chloro-N-(2,4-difluorophenyl)-2-oxo-1-(4-(trifluoromethyl)benzyl)-1,2-dihydropyridine-3-carboxamide" [P]. 中国发明专利, 专利号 CN 111736090 A, 授权公告日 2019-07-15.
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". Talanta, 2010, 850, (2), 4403-4412.
Zhou X P, Huang L, Wu G. "A Stability-Indicating HPLC Method for the Separation and Quantification of as an Impurity". Rapid Commun. Mass Spectrom., 2024, 990, (2), 9505-9519.
Martinez C, Lopez D R. "Identification and Structural Characterization of a Novel Degradation Product of 5-Chloro-N-(2,4-difluorophenyl)-2-oxo-1-(4-(trifluoromethyl)benzyl)-1,2-dihydropyridine-3-carboxamide Using HRMS and NMR". Anal. Chim. Acta, 2021, 1431, 9252-9261.
Kowalski T, Nowak Z. "Forced Degradation Studies to Evaluate Profile in Drug Substances According to ICH Guidelines". Sci. Total Environ., 2022, 671, 1327-1340.