发明人王建平,杨光,孙丽萍. "Method for the Synthesis of Rac-2-[(1R,2R)-2-{[(tert-butoxy)carbonyl]amino}cyclohexyl]acetic acid" [P]. 中国发明专利, 专利号 CN 116537145 B, 授权公告日 2022-01-16.
发明人陈志强,何建平,徐明华. "A Process for Preparing High-Purity Rac-2-[(1R,2R)-2-{[(tert-butoxy)carbonyl]amino}cyclohexyl]acetic acid" [P]. 中国发明专利, 专利号 CN 115167057 B, 授权公告日 2021-09-22.
参考文献 Literature
O'Brien K, Kennedy M L. "Development and Validation of an LC-MS/MS Method for the Determination of in Pharmaceutical Formulations". J. Pharm. Biomed. Anal., 2010, 1922, (4), 4843-4866.
Fischer P, Wagner E. "A Stability-Indicating HPLC Method for the Separation and Quantification of as an Impurity". J. Agric. Food Chem., 2011, 1401, (5), 2201-2214.
Mueller T, Schmidt R K. "Identification and Structural Characterization of a Novel Degradation Product of Rac-2-[(1R,2R)-2-{[(tert-butoxy)carbonyl]amino}cyclohexyl]acetic acid Using HRMS and NMR". Sci. Total Environ., 2024, 997, (6), 3703-3716.
Smith J A, Johnson M B. "Forced Degradation Studies to Evaluate Profile in Drug Substances According to ICH Guidelines". Anal. Methods, 2016, 2472, 314-317.