Identification, synthesis and strategy for minimization of potential impurities in the synthesis of suvorexant

Xunlei Lva School of Pharmacy, Fudan University, Shanghai, China;b State Key Laboratory of New Drug and Pharmaceutical Process, Shanghai Key Laboratory of Anti-infectives, State Institute of Pharmaceutical Industry, Shanghai, China

Jing Pana School of Pharmacy, Fudan University, Shanghai, China;b State Key Laboratory of New Drug and Pharmaceutical Process, Shanghai Key Laboratory of Anti-infectives, State Institute of Pharmaceutical Industry, Shanghai, China

Weiyuan Liub State Key Laboratory of New Drug and Pharmaceutical Process, Shanghai Key Laboratory of Anti-infectives, State Institute of Pharmaceutical Industry, Shanghai, China

Xue Mengb State Key Laboratory of New Drug and Pharmaceutical Process, Shanghai Key Laboratory of Anti-infectives, State Institute of Pharmaceutical Industry, Shanghai, China

Liang Chenb State Key Laboratory of New Drug and Pharmaceutical Process, Shanghai Key Laboratory of Anti-infectives, State Institute of Pharmaceutical Industry, Shanghai, China

Ting Zhoub State Key Laboratory of New Drug and Pharmaceutical Process, Shanghai Key Laboratory of Anti-infectives, State Institute of Pharmaceutical Industry, Shanghai, China

Kuaile Linb State Key Laboratory of New Drug and Pharmaceutical Process, Shanghai Key Laboratory of Anti-infectives, State Institute of Pharmaceutical Industry, Shanghai, China

Deyong Yea School of Pharmacy, Fudan University, Shanghai, ChinaCorrespondence[email protected]

Weicheng Zhoub State Key Laboratory of New Drug and Pharmaceutical Process, Shanghai Key Laboratory of Anti-infectives, State Institute of Pharmaceutical Industry, Shanghai, ChinaCorrespondence[email protected]

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Abstract

Eight process-related impurities in the synthesis of suvorexant were identified, while six of them were described for the first time. In order to get the references for the process optimization and quality control of API, the eight compounds were synthesized. According to the possible formation pathways, a modified synthesis and the strategy for impurity control in the corresponding reactions were established.

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Identification, synthesis and strategy for minimization of potential impurities in the synthesis of suvorexant

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Identification, synthesis and strategy for minimization of potential impurities in the synthesis of suvorexant

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