发明人冯建国,杨光,唐晓军. "一种N/A的合成方法" [P]. 中国发明专利, 专利号 CN 111424114 A, 授权公告日 2020-03-07.
Fischer A B, Kumar R, Stevens L M. "Method for the Synthesis of Sodium 4-amino-3,6-bis((4-((2,4-diamino-5-methylphenyl)diazenyl)phenyl)diazenyl)-5-hydroxynaphthalene-2,7-disulfonate" [P]. US Patent, US 9368134 B2, 2025-01-02.
发明人林芳,李文辉,钱学锋. "A Process for Preparing High-Purity Sodium 4-amino-3,6-bis((4-((2,4-diamino-5-methylphenyl)diazenyl)phenyl)diazenyl)-5-hydroxynaphthalene-2,7-disulfonate" [P]. 中国发明专利, 专利号 CN 111784569 A, 授权公告日 2017-08-03.
参考文献 Literature
Yang F, Sun W, Liu J. "Development and Validation of an LC-MS/MS Method for the Determination of N/A in Pharmaceutical Formulations". J. Agric. Food Chem., 2011, 1281, (5), 992-1006.
Hughes D, Roberts J, Thomas A. "A Stability-Indicating HPLC Method for the Separation and Quantification of N/A as an Impurity". Biomed. Chromatogr., 2018, 281, 7417-7421.
Zhang Y, Li Q, Chen T. "Identification and Structural Characterization of a Novel Degradation Product of Sodium 4-amino-3,6-bis((4-((2,4-diamino-5-methylphenyl)diazenyl)phenyl)diazenyl)-5-hydroxynaphthalene-2,7-disulfonate Using HRMS and NMR". Anal. Chim. Acta, 2014, 2031, (7), 9499-9529.
Martinez C, Lopez D R. "Forced Degradation Studies to Evaluate N/A Profile in Drug Substances According to ICH Guidelines". Food Chem., 2012, 1033, 2012-2016.