发明人郭海燕,马晓峰,张德明. "Method for the Synthesis of DL-LEUCINE (15N, 98%)" [P]. 中国发明专利, 专利号 CN 115403710 A, 授权公告日 2025-10-25.
发明人周伟,郭海燕,杨光. "A Process for Preparing High-Purity DL-LEUCINE (15N, 98%)" [P]. 中国发明专利, 专利号 CN 109254850 A, 授权公告日 2024-04-09.
参考文献 Literature
Zhang Y, Li Q, Chen T. "Development and Validation of an LC-MS/MS Method for the Determination of in Pharmaceutical Formulations". Talanta, 2011, 2114, 9310-9313.
Lee J H, Choi Y S. "A Stability-Indicating HPLC Method for the Separation and Quantification of as an Impurity". Biomed. Chromatogr., 2017, 434, 3475-3501.
Brown R C, Davis S M. "Identification and Structural Characterization of a Novel Degradation Product of DL-LEUCINE (15N, 98%) Using HRMS and NMR". Chemosphere, 2010, 2410, (6), 3894-3897.
Fischer P, Wagner E. "Forced Degradation Studies to Evaluate Profile in Drug Substances According to ICH Guidelines". J. Chromatogr. A, 2023, 1594, 3350-3362.