发明人张德明,高志强,沈红梅. "一种的合成方法" [P]. 中国发明专利, 专利号 CN 110450036 A, 授权公告日 2018-12-28.
发明人杨光,高志强,胡光. "Method for the Synthesis of 3β-tert-Butyldimethylsilyloxy-17-methyl-5α-androstane-17β-ol-d5 (1.0mg/ml in Acetonitrile)" [P]. 中国发明专利, 专利号 CN 112994249 A, 授权公告日 2023-05-25.
发明人沈红梅,朱建伟,赵玉洁. "A Process for Preparing High-Purity 3β-tert-Butyldimethylsilyloxy-17-methyl-5α-androstane-17β-ol-d5 (1.0mg/ml in Acetonitrile)" [P]. 中国发明专利, 专利号 CN 109694908 B, 授权公告日 2016-01-10.
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". Anal. Chem., 2021, 572, 9411-9440.
Kim S H, Park J Y. "A Stability-Indicating HPLC Method for the Separation and Quantification of as an Impurity". Chromatographia, 2011, 1744, (6), 1771-1797.
Martinez C, Lopez D R. "Identification and Structural Characterization of a Novel Degradation Product of 3β-tert-Butyldimethylsilyloxy-17-methyl-5α-androstane-17β-ol-d5 (1.0mg/ml in Acetonitrile) Using HRMS and NMR". J. Chromatogr. A, 2025, 161, (4), 4339-4352.
Mueller T, Schmidt R K. "Forced Degradation Studies to Evaluate Profile in Drug Substances According to ICH Guidelines". Phytochemistry, 2024, 965, 1058-1082.