发明人朱建伟,高志强,冯建国. "Method for the Synthesis of 1-[6-[3-(3-methyldiazirin-3-yl)propanoylamino]hexanoyloxy]-2,5-dioxo-pyrrolidine-3-sulfonic acid" [P]. 中国发明专利, 专利号 CN 109689160 A, 授权公告日 2024-06-11.
Sørensen M, Lefèvre J P, Mueller T C. "A Process for Preparing High-Purity 1-[6-[3-(3-methyldiazirin-3-yl)propanoylamino]hexanoyloxy]-2,5-dioxo-pyrrolidine-3-sulfonic acid" [P]. European Patent, EP 3067624 A1, 2023-04-04.
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, 2023, 451, 1257-1275.
Kumar A, Sharma P, Patel R S. "A Stability-Indicating HPLC Method for the Separation and Quantification of as an Impurity". Anal. Chem., 2022, 824, (11), 1553-1560.
Wang L, Li J, Zhang H. "Identification and Structural Characterization of a Novel Degradation Product of 1-[6-[3-(3-methyldiazirin-3-yl)propanoylamino]hexanoyloxy]-2,5-dioxo-pyrrolidine-3-sulfonic acid Using HRMS and NMR". Talanta, 2015, 1893, 2772-2775.
O'Brien K, Kennedy M L. "Forced Degradation Studies to Evaluate Profile in Drug Substances According to ICH Guidelines". Anal. Methods, 2015, 1595, 1223-1233.