发明人王建平,黄志刚,张德明. "一种的合成方法" [P]. 中国发明专利, 专利号 CN 112188684 A, 授权公告日 2023-03-08.
发明人罗永刚,郑宇鹏,马晓峰. "Method for the Synthesis of tetrahydro-4-[(2-hydroxypropyl)amino]-Thiophene-3-ol,1,1-dioxide,ethanedioate (1:1)" [P]. 中国发明专利, 专利号 CN 111330706 B, 授权公告日 2025-06-04.
发明人王建平,刘建华,高志强. "A Process for Preparing High-Purity tetrahydro-4-[(2-hydroxypropyl)amino]-Thiophene-3-ol,1,1-dioxide,ethanedioate (1:1)" [P]. 中国发明专利, 专利号 CN 111030524 A, 授权公告日 2024-06-25.
参考文献 Literature
Yamamoto K, Tanaka H, Suzuki T. "Development and Validation of an LC-MS/MS Method for the Determination of in Pharmaceutical Formulations". J. Nat. Prod., 2011, 1534, 4904-4910.
Wang L, Li J, Zhang H. "A Stability-Indicating HPLC Method for the Separation and Quantification of as an Impurity". Anal. Methods, 2014, 406, (2), 3185-3192.
O'Brien K, Kennedy M L. "Identification and Structural Characterization of a Novel Degradation Product of tetrahydro-4-[(2-hydroxypropyl)amino]-Thiophene-3-ol,1,1-dioxide,ethanedioate (1:1) Using HRMS and NMR". Rapid Commun. Mass Spectrom., 2012, 176, (4), 4482-4500.
Yang F, Sun W, Liu J. "Forced Degradation Studies to Evaluate Profile in Drug Substances According to ICH Guidelines". Anal. Chim. Acta, 2021, 1213, 4051-4066.