Sørensen M, Martínez F, Mueller T C. "Method for the Synthesis of 2-Hydrazinyl-4,5,6,7-tetrahydro-1H-1,3-diazepine hydrochloride" [P]. European Patent, EP 3180001 A1, 2024-09-02.
Björnsson E, Lefèvre J P, Kowalski A. "A Process for Preparing High-Purity 2-Hydrazinyl-4,5,6,7-tetrahydro-1H-1,3-diazepine hydrochloride" [P]. European Patent, EP 3326763 A1, 2023-12-04.
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". Chemosphere, 2015, 730, (7), 1876-1880.
Brown R C, Davis S M. "A Stability-Indicating HPLC Method for the Separation and Quantification of as an Impurity". Rapid Commun. Mass Spectrom., 2023, 2353, (11), 7450-7469.
Zhou X P, Huang L, Wu G. "Identification and Structural Characterization of a Novel Degradation Product of 2-Hydrazinyl-4,5,6,7-tetrahydro-1H-1,3-diazepine hydrochloride Using HRMS and NMR". J. Chromatogr. A, 2011, 2102, 7585-7615.
Chen X Y, Liu M, Zhao W Q. "Forced Degradation Studies to Evaluate Profile in Drug Substances According to ICH Guidelines". J. Pharm. Biomed. Anal., 2016, 789, (2), 1466-1496.