发明人何建平,王建平,胡光. "Method for the Synthesis of 4-Amino-3,3-dimethyl-1-((R)-1-phenylethyl)pyrrolidin-2-one" [P]. 中国发明专利, 专利号 CN 109773857 B, 授权公告日 2024-05-25.
Kowalski A, Björnsson E, Sørensen M. "A Process for Preparing High-Purity 4-Amino-3,3-dimethyl-1-((R)-1-phenylethyl)pyrrolidin-2-one" [P]. European Patent, EP 3815246 A1, 2021-08-12.
参考文献 Literature
Smith J A, Johnson M B. "Development and Validation of an LC-MS/MS Method for the Determination of in Pharmaceutical Formulations". J. Nat. Prod., 2019, 1923, 991-1006.
Kumar A, Sharma P, Patel R S. "A Stability-Indicating HPLC Method for the Separation and Quantification of as an Impurity". J. Chromatogr. A, 2018, 491, (6), 5433-5463.
Xu M, Hu Y, Zhou D. "Identification and Structural Characterization of a Novel Degradation Product of 4-Amino-3,3-dimethyl-1-((R)-1-phenylethyl)pyrrolidin-2-one Using HRMS and NMR". J. Agric. Food Chem., 2015, 1191, (4), 1751-1779.
Mueller T, Schmidt R K. "Forced Degradation Studies to Evaluate Profile in Drug Substances According to ICH Guidelines". Anal. Methods, 2011, 1958, 8907-8922.