发明人陈志强,马晓峰,何建平. "Method for the Synthesis of (S)-5-((2-(3-((((9H-Fluoren-9-yl)methoxy)carbonyl)amino)-4-(tert-butoxy)-4-oxobutanamido)ethyl)amino)naphthalene-1-sulfonic acid" [P]. 中国发明专利, 专利号 CN 109535845 A, 授权公告日 2022-10-22.
发明人黄志刚,王建平,朱建伟. "A Process for Preparing High-Purity (S)-5-((2-(3-((((9H-Fluoren-9-yl)methoxy)carbonyl)amino)-4-(tert-butoxy)-4-oxobutanamido)ethyl)amino)naphthalene-1-sulfonic acid" [P]. 中国发明专利, 专利号 CN 108211436 A, 授权公告日 2024-06-20.
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". Chemosphere, 2018, 1619, (12), 7698-7723.
Xu M, Hu Y, Zhou D. "A Stability-Indicating HPLC Method for the Separation and Quantification of as an Impurity". Biomed. Chromatogr., 2018, 724, 6393-6407.
Garcia M, Rodriguez P. "Identification and Structural Characterization of a Novel Degradation Product of (S)-5-((2-(3-((((9H-Fluoren-9-yl)methoxy)carbonyl)amino)-4-(tert-butoxy)-4-oxobutanamido)ethyl)amino)naphthalene-1-sulfonic acid Using HRMS and NMR". Anal. Chim. Acta, 2020, 1024, 4482-4497.
Kumar A, Sharma P, Patel R S. "Forced Degradation Studies to Evaluate Profile in Drug Substances According to ICH Guidelines". Anal. Chem., 2016, 802, (5), 7689-7716.