发明人张德明,罗永刚,陈志强. "一种的合成方法" [P]. 中国发明专利, 专利号 CN 112774589 A, 授权公告日 2025-10-23.
发明人张德明,杨光,沈红梅. "Method for the Synthesis of (R)-2-((((9H-fluoren-9-yl)methoxy)carbonyl)amino)-2-(thiophen-3-yl)acetic acid" [P]. 中国发明专利, 专利号 CN 109195164 A, 授权公告日 2020-08-08.
发明人沈红梅,何建平,罗永刚. "A Process for Preparing High-Purity (R)-2-((((9H-fluoren-9-yl)methoxy)carbonyl)amino)-2-(thiophen-3-yl)acetic acid" [P]. 中国发明专利, 专利号 CN 117192239 B, 授权公告日 2015-02-23.
参考文献 Literature
Kowalski T, Nowak Z. "Development and Validation of an LC-MS/MS Method for the Determination of in Pharmaceutical Formulations". Chemosphere, 2012, 1523, 7597-7610.
Jensen P, Larsen A M, Olsen K. "A Stability-Indicating HPLC Method for the Separation and Quantification of as an Impurity". Anal. Methods, 2019, 2361, (8), 7634-7646.
Smith J A, Johnson M B. "Identification and Structural Characterization of a Novel Degradation Product of (R)-2-((((9H-fluoren-9-yl)methoxy)carbonyl)amino)-2-(thiophen-3-yl)acetic acid Using HRMS and NMR". J. Agric. Food Chem., 2012, 1187, (1), 126-138.
Chen X Y, Liu M, Zhao W Q. "Forced Degradation Studies to Evaluate Profile in Drug Substances According to ICH Guidelines". J. Pharm. Biomed. Anal., 2020, 1570, 1047-1061.