Chinese Journal of Pharmacovigilance ›› 2016, Vol. 13 ›› Issue (12): 730-732.

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Research on Preparation Process Optimizing of Fluoxertine Hydrochloride Impurity

LIU Bo1, WANG Teng1, WU Di1, 2, PANG Yu3, SONG Yong-ji1, *   

  1. 1 Chemical Engineering College, Beijing Institute of Petrochemical Technology, Beijing 102607, China;
    2 Chemical Engineering College, Beijing University of Chemical Technology, Beijing 100029, China;
    3 Center of Drug reevaluation, CFDA, Beijing 100045, China
  • Received:2017-01-13 Revised:2017-01-13 Online:2016-12-20 Published:2017-01-13

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Abstract: Objective To develop a rapid and effective method for preparation of the fluoxertine hydrochloride related substanceⅢ in ChP 2015 by optimizing the preparation process. Methods Via verification of multiple factors (temperature, concentration and pH condition) and structure confirmation by NMR and HR-MS, finally, the optimum condition was founded. Results The process was an one-pot continuous method, the total yield was 82.05%. Conclusion An effective and rapid preparation route to synthesize compound hydrochloride N-menthyl-3-benzedrine was developed, which is the fluoxertine hydrochloride related substanceⅢ in ChP 2015. It also laid a foundation for the study of toxic mechanism, quality specification improvement and adverse reaction reducing of fluoxertine hydrochloride.

Key words: fluoxertine hydrochloride, fluoxertine hydrochloride impurity Ⅲ, process optimizing, related substance

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