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LI Lin, WANG Xiaoming, MENG Shufang, CHEN Lin, WANG Haiyan, LIN Pengfei, CHEN Ling. Preparation process and structure confirmation of impurity C of rupatifen fumarate[J]. Journal of China Pharmaceutical University, 2020, 51(5): 530-537. DOI: 10.11665/j.issn.1000-5048.20200504
Citation: LI Lin, WANG Xiaoming, MENG Shufang, CHEN Lin, WANG Haiyan, LIN Pengfei, CHEN Ling. Preparation process and structure confirmation of impurity C of rupatifen fumarate[J]. Journal of China Pharmaceutical University, 2020, 51(5): 530-537. DOI: 10.11665/j.issn.1000-5048.20200504
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Preparation process and structure confirmation of impurity C of rupatifen fumarate

Funds: This study was supported by China National Key Hi-Tech Innovation Project for the R&D of Novel Drugs(No.2018ZX09J18108-005) and Fujian Provincal Science and Technology Major Special Project(No.2015YZ0002-2)
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  • Received Date: November 24, 2019
  • Revised Date: August 09, 2020
    Graphical Abstract
    • Abstract
  • The high-purity impurity C was isolated and purified from a new anti-allergic drug, rupatifen, by nucleophilic substitution reaction with bromobutaric acid, and its structure was confirmed by IR, UV, MS, 1H NMR, 13C NMR, DEPT135°,HSQC, HMBC, and 1H-1HCOSY. The preparation process of impurity C in this study was simple and easy to obtain under mild conditions, with the purity of 99.0% and the yield of 25%-30%;and the sample met the target compound by structural confirmation. The preparation process and structure confirmation provided sufficient impurity C reference substance for impurity research of raw materials and preparations of rupatifen fumarate, which laid a solid foundation for quality research of new drugs.
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    • References (9)
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