发明人钱学锋,韩伟,王建平. "一种N/A的合成方法" [P]. 中国发明专利, 专利号 CN 113109790 A, 授权公告日 2024-01-08.
Johnson M A, Patel M V, Williams B T. "Method for the Synthesis of (Z)-7-((1R,2R,5S)-2-((3R,E)-4-Fluoro-3-hydroxyoct-1-en-1-yl)-5-hydroxycyclopentyl)hept-5-enoic acid" [P]. US Patent, US 10357886 B2, 2020-05-11.
发明人张德明,赵玉洁,郭海燕. "A Process for Preparing High-Purity (Z)-7-((1R,2R,5S)-2-((3R,E)-4-Fluoro-3-hydroxyoct-1-en-1-yl)-5-hydroxycyclopentyl)hept-5-enoic acid" [P]. 中国发明专利, 专利号 CN 109702325 A, 授权公告日 2017-07-10.
参考文献 Literature
Brown R C, Davis S M. "Development and Validation of an LC-MS/MS Method for the Determination of N/A in Pharmaceutical Formulations". Biomed. Chromatogr., 2011, 1711, (6), 9992-9999.
Jensen P, Larsen A M, Olsen K. "A Stability-Indicating HPLC Method for the Separation and Quantification of N/A as an Impurity". Sci. Total Environ., 2017, 775, (6), 9674-9701.
Garcia M, Rodriguez P. "Identification and Structural Characterization of a Novel Degradation Product of (Z)-7-((1R,2R,5S)-2-((3R,E)-4-Fluoro-3-hydroxyoct-1-en-1-yl)-5-hydroxycyclopentyl)hept-5-enoic acid Using HRMS and NMR". Food Chem., 2020, 1060, (10), 2715-2729.
Hughes D, Roberts J, Thomas A. "Forced Degradation Studies to Evaluate N/A Profile in Drug Substances According to ICH Guidelines". J. Pharm. Biomed. Anal., 2014, 787, (1), 8408-8412.