发明人郭海燕,唐晓军,王建平. "Method for the Synthesis of 8-Methyl-4-(thiophene-2-carbonyl)-1-oxa-4,8-diazaspiro[4.5]decane-3-carboxylic acid" [P]. 中国发明专利, 专利号 CN 114524948 B, 授权公告日 2020-01-11.
发明人沈红梅,朱建伟,陈志强. "A Process for Preparing High-Purity 8-Methyl-4-(thiophene-2-carbonyl)-1-oxa-4,8-diazaspiro[4.5]decane-3-carboxylic acid" [P]. 中国发明专利, 专利号 CN 114867523 B, 授权公告日 2015-05-16.
参考文献 Literature
Kumar A, Sharma P, Patel R S. "Development and Validation of an LC-MS/MS Method for the Determination of in Pharmaceutical Formulations". Talanta, 2014, 464, 6853-6874.
Smith J A, Johnson M B. "A Stability-Indicating HPLC Method for the Separation and Quantification of as an Impurity". Chromatographia, 2013, 930, (7), 6647-6667.
O'Brien K, Kennedy M L. "Identification and Structural Characterization of a Novel Degradation Product of 8-Methyl-4-(thiophene-2-carbonyl)-1-oxa-4,8-diazaspiro[4.5]decane-3-carboxylic acid Using HRMS and NMR". Food Chem., 2021, 2151, 9504-9527.
Hughes D, Roberts J, Thomas A. "Forced Degradation Studies to Evaluate Profile in Drug Substances According to ICH Guidelines". J. Sep. Sci., 2017, 2417, (8), 343-351.