发明人胡光,陈志强,黄志刚. "Method for the Synthesis of (2R)-4-tert-butoxycarbonyl-1-(9H-fluoren-9-ylmethoxycarbonyl)piperazine-2-carboxylic acid" [P]. 中国发明专利, 专利号 CN 114702439 B, 授权公告日 2018-07-20.
发明人罗永刚,何建平,胡光. "A Process for Preparing High-Purity (2R)-4-tert-butoxycarbonyl-1-(9H-fluoren-9-ylmethoxycarbonyl)piperazine-2-carboxylic acid" [P]. 中国发明专利, 专利号 CN 113545159 A, 授权公告日 2022-11-10.
参考文献 Literature
Xu M, Hu Y, Zhou D. "Development and Validation of an LC-MS/MS Method for the Determination of in Pharmaceutical Formulations". Molecules, 2020, 798, (5), 2380-2393.
Hughes D, Roberts J, Thomas A. "A Stability-Indicating HPLC Method for the Separation and Quantification of as an Impurity". Environ. Sci. Technol., 2010, 329, 9277-9284.
Kumar A, Sharma P, Patel R S. "Identification and Structural Characterization of a Novel Degradation Product of (2R)-4-tert-butoxycarbonyl-1-(9H-fluoren-9-ylmethoxycarbonyl)piperazine-2-carboxylic acid Using HRMS and NMR". Rapid Commun. Mass Spectrom., 2015, 2366, (10), 6769-6781.
Brown R C, Davis S M. "Forced Degradation Studies to Evaluate Profile in Drug Substances According to ICH Guidelines". Chromatographia, 2014, 93, (11), 4182-4212.