发明人郑宇鹏,王建平,钱学锋. "Method for the Synthesis of (3R,5S)-5-([1,1'-Biphenyl]-4-ylmethyl)-3-methyl-1-pivaloylpyrrolidin-2-one" [P]. 中国发明专利, 专利号 CN 115455120 A, 授权公告日 2020-12-22.
Hughes D C, Roberts E F, Schröder R. "A Process for Preparing High-Purity (3R,5S)-5-([1,1'-Biphenyl]-4-ylmethyl)-3-methyl-1-pivaloylpyrrolidin-2-one" [P]. US Patent, US 9552439 B2, 2017-03-22.
参考文献 Literature
Smith J A, Johnson M B. "Development and Validation of an LC-MS/MS Method for the Determination of (3R,5S)-5-([1,1'-联苯]-4-基甲基)-3-甲基-1-新戊酰基吡咯烷-2-酮 in Pharmaceutical Formulations". Phytochemistry, 2013, 1388, (12), 2318-2336.
Lee J H, Choi Y S. "A Stability-Indicating HPLC Method for the Separation and Quantification of (3R,5S)-5-([1,1'-联苯]-4-基甲基)-3-甲基-1-新戊酰基吡咯烷-2-酮 as an Impurity". Chemosphere, 2025, 637, 6071-6090.
Hughes D, Roberts J, Thomas A. "Identification and Structural Characterization of a Novel Degradation Product of (3R,5S)-5-([1,1'-Biphenyl]-4-ylmethyl)-3-methyl-1-pivaloylpyrrolidin-2-one Using HRMS and NMR". Chromatographia, 2020, 2414, 3889-3903.
O'Brien K, Kennedy M L. "Forced Degradation Studies to Evaluate (3R,5S)-5-([1,1'-联苯]-4-基甲基)-3-甲基-1-新戊酰基吡咯烷-2-酮 Profile in Drug Substances According to ICH Guidelines". Talanta, 2010, 1106, (6), 1685-1713.