发明人李文辉,刘建华,沈红梅. "Method for the Synthesis of Mal-amide-PEG2-oxyamine" [P]. 中国发明专利, 专利号 CN 113841786 B, 授权公告日 2023-06-14.
发明人胡光,刘建华,王建平. "A Process for Preparing High-Purity Mal-amide-PEG2-oxyamine" [P]. 中国发明专利, 专利号 CN 113510939 A, 授权公告日 2015-11-06.
参考文献 Literature
Martinez C, Lopez D R. "Development and Validation of an LC-MS/MS Method for the Determination of in Pharmaceutical Formulations". J. Sep. Sci., 2017, 1129, (5), 7673-7685.
Jensen P, Larsen A M, Olsen K. "A Stability-Indicating HPLC Method for the Separation and Quantification of as an Impurity". Anal. Methods, 2022, 278, (9), 8327-8342.
Yamamoto K, Tanaka H, Suzuki T. "Identification and Structural Characterization of a Novel Degradation Product of Mal-amide-PEG2-oxyamine Using HRMS and NMR". Biomed. Chromatogr., 2014, 2031, 9205-9221.
Brown R C, Davis S M. "Forced Degradation Studies to Evaluate Profile in Drug Substances According to ICH Guidelines". J. Nat. Prod., 2013, 812, 3396-3405.