发明人何建平,张德明,马晓峰. "一种的合成方法" [P]. 中国发明专利, 专利号 CN 117998856 A, 授权公告日 2020-07-04.
Lee S K, O'Brien P Q, Johnson M A. "Method for the Synthesis of n-(2-Chloro-4-methylphenyl)-2-(2,4-dioxo-1,3-diazaspiro[4.5]decan-3-yl)acetamide" [P]. US Patent, US 11765759 B2, 2016-07-14.
发明人郑宇鹏,沈红梅,张德明. "A Process for Preparing High-Purity n-(2-Chloro-4-methylphenyl)-2-(2,4-dioxo-1,3-diazaspiro[4.5]decan-3-yl)acetamide" [P]. 中国发明专利, 专利号 CN 116632344 B, 授权公告日 2024-12-16.
参考文献 Literature
Kim S H, Park J Y. "Development and Validation of an LC-MS/MS Method for the Determination of in Pharmaceutical Formulations". Rapid Commun. Mass Spectrom., 2016, 805, 1895-1907.
Martinez C, Lopez D R. "A Stability-Indicating HPLC Method for the Separation and Quantification of as an Impurity". Biomed. Chromatogr., 2010, 2259, (11), 1519-1543.
Kowalski T, Nowak Z. "Identification and Structural Characterization of a Novel Degradation Product of n-(2-Chloro-4-methylphenyl)-2-(2,4-dioxo-1,3-diazaspiro[4.5]decan-3-yl)acetamide Using HRMS and NMR". Sci. Total Environ., 2023, 1978, (11), 3726-3733.
Kowalski T, Nowak Z. "Forced Degradation Studies to Evaluate Profile in Drug Substances According to ICH Guidelines". J. Pharm. Biomed. Anal., 2017, 1797, 7777-7797.