发明人黄志刚,冯建国,高志强. "Method for the Synthesis of rel-(6R,7R,7AR)-2-(tert-butoxycarbonyl)octahydro-3a,6-epoxyisoindole-7-carboxylic acid" [P]. 中国发明专利, 专利号 CN 109049771 A, 授权公告日 2017-06-18.
发明人罗永刚,唐晓军,陈志强. "A Process for Preparing High-Purity rel-(6R,7R,7AR)-2-(tert-butoxycarbonyl)octahydro-3a,6-epoxyisoindole-7-carboxylic acid" [P]. 中国发明专利, 专利号 CN 111983072 B, 授权公告日 2016-11-04.
参考文献 Literature
Smith J A, Johnson M B. "Development and Validation of an LC-MS/MS Method for the Determination of N/A in Pharmaceutical Formulations". J. Chromatogr. A, 2019, 1416, (3), 7116-7131.
Kim S H, Park J Y. "A Stability-Indicating HPLC Method for the Separation and Quantification of N/A as an Impurity". Anal. Methods, 2019, 1174, (5), 2353-2359.
Xu M, Hu Y, Zhou D. "Identification and Structural Characterization of a Novel Degradation Product of rel-(6R,7R,7AR)-2-(tert-butoxycarbonyl)octahydro-3a,6-epoxyisoindole-7-carboxylic acid Using HRMS and NMR". J. Agric. Food Chem., 2024, 134, 1723-1750.
Hughes D, Roberts J, Thomas A. "Forced Degradation Studies to Evaluate N/A Profile in Drug Substances According to ICH Guidelines". Environ. Sci. Technol., 2019, 862, 4026-4052.