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郭伟, 解春文, 王文笙, 郑德强, 何淑旺. 替比培南酯有关物质的合成[J]. 中国药科大学学报, 2018, 49(3): 286-290. DOI: 10.11665/j.issn.1000-5048.20180305
引用本文: 郭伟, 解春文, 王文笙, 郑德强, 何淑旺. 替比培南酯有关物质的合成[J]. 中国药科大学学报, 2018, 49(3): 286-290. DOI: 10.11665/j.issn.1000-5048.20180305
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GUO Wei, XIE Chunwen, WANG Wensheng, ZHENG Deqiang, HE Shuwang. Synthesis of related substances of tebipenem pivoxil[J]. Journal of China Pharmaceutical University, 2018, 49(3): 286-290. DOI: 10.11665/j.issn.1000-5048.20180305
Citation: GUO Wei, XIE Chunwen, WANG Wensheng, ZHENG Deqiang, HE Shuwang. Synthesis of related substances of tebipenem pivoxil[J]. Journal of China Pharmaceutical University, 2018, 49(3): 286-290. DOI: 10.11665/j.issn.1000-5048.20180305
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替比培南酯有关物质的合成

Synthesis of related substances of tebipenem pivoxil

    摘要
  • 摘要: 为了完善与强化对替比培南酯原料药的质量控制，建立替比培南酯原料药的质量标准，从替比培南酯的合成路线入手，分析并合成其中可能存在的5种有关物质:P1、P2、P6、P8、P9，并经1H NMR和MS确证。纯度经HPLC确证在95%以上。合成的有关物质可以作为替比培南酯药物质量控制的杂质对照品，该合成方法条件温和、原料易得、操作简单。

     

    Abstract: To enhance the quality control of tebipenem pivoxil and establish its quality criteria, the synthetic route of tebipenem pivoxil was analyzed and five related substances(P1, P2, P6, P8 and P9)were synthesized and characterized by 1H NMR and MS. The purities of the related substances were over 95% via HPLC detection. The target compounds can be used as the reference of the related substances in the quality control of tebipenem pivoxil. The starting materials were cheap and easy to obtain; the reaction conditions were mild.

     

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