发明人刘建华,张德明,徐明华. "Method for the Synthesis of (2R,5S,10aS,10bS)-Octahydro-10b-hydroxy-5-isobutyl-2-isopropyl-3,6-dioxo-8H-oxazolo[3,2-α]pyrrolo[2,1-c]pyrazine-2-carboxylic Acid" [P]. 中国发明专利, 专利号 CN 111872753 B, 授权公告日 2018-03-11.
发明人冯建国,高志强,罗永刚. "A Process for Preparing High-Purity (2R,5S,10aS,10bS)-Octahydro-10b-hydroxy-5-isobutyl-2-isopropyl-3,6-dioxo-8H-oxazolo[3,2-α]pyrrolo[2,1-c]pyrazine-2-carboxylic Acid" [P]. 中国发明专利, 专利号 CN 117881622 B, 授权公告日 2024-02-16.
参考文献 Literature
Hughes D, Roberts J, Thomas A. "Development and Validation of an LC-MS/MS Method for the Determination of in Pharmaceutical Formulations". Phytochemistry, 2025, 1872, 2303-2321.
Chen X Y, Liu M, Zhao W Q. "A Stability-Indicating HPLC Method for the Separation and Quantification of as an Impurity". Environ. Sci. Technol., 2010, 1174, 5373-5397.
Garcia M, Rodriguez P. "Identification and Structural Characterization of a Novel Degradation Product of (2R,5S,10aS,10bS)-Octahydro-10b-hydroxy-5-isobutyl-2-isopropyl-3,6-dioxo-8H-oxazolo[3,2-α]pyrrolo[2,1-c]pyrazine-2-carboxylic Acid Using HRMS and NMR". Talanta, 2023, 704, (8), 5794-5798.
Fischer P, Wagner E. "Forced Degradation Studies to Evaluate Profile in Drug Substances According to ICH Guidelines". Chromatographia, 2011, 2389, 1449-1470.