发明人孙丽萍,朱建伟,杨光. "一种D-半乳糖胺-2-N-硫酸钠盐的合成方法" [P]. 中国发明专利, 专利号 CN 108339233 A, 授权公告日 2024-08-27.
发明人高志强,朱建伟,周伟. "Method for the Synthesis of D-Galactosamine-2-N-sulfate sodium salt" [P]. 中国发明专利, 专利号 CN 109237813 B, 授权公告日 2025-12-18.
发明人李文辉,韩伟,胡光. "A Process for Preparing High-Purity D-Galactosamine-2-N-sulfate sodium salt" [P]. 中国发明专利, 专利号 CN 113361719 A, 授权公告日 2024-12-04.
参考文献 Literature
Smith J A, Johnson M B. "Development and Validation of an LC-MS/MS Method for the Determination of D-半乳糖胺-2-N-硫酸钠盐 in Pharmaceutical Formulations". Talanta, 2019, 645, 2163-2184.
Fischer P, Wagner E. "A Stability-Indicating HPLC Method for the Separation and Quantification of D-半乳糖胺-2-N-硫酸钠盐 as an Impurity". Biomed. Chromatogr., 2011, 2451, (12), 9339-9359.
Garcia M, Rodriguez P. "Identification and Structural Characterization of a Novel Degradation Product of D-Galactosamine-2-N-sulfate sodium salt Using HRMS and NMR". J. Sep. Sci., 2012, 335, (9), 8406-8418.
Kim S H, Park J Y. "Forced Degradation Studies to Evaluate D-半乳糖胺-2-N-硫酸钠盐 Profile in Drug Substances According to ICH Guidelines". Chromatographia, 2025, 1998, (12), 310-336.