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| 摘要: |
| 目的 探讨多肽合成中非对映异构体杂质的研究和控制。方法 介绍多肽合成中氨基酸消旋的机制，从合成原料质量控制、工艺过程控制和检测方法选择等方面提供有益建议。结果 部分氨基酸消旋产生的非对映异构体杂质是合成多肽药物有关物质研究的重要内容之一。结论 应重视非对映异构体杂质的研究和控制。 |
| 关键词: 合成多肽 消旋 非对映异构体 |
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| Control of the Diastereoisomeric Impurities in Synthetic Peptide Drugs |
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KANG Jianlei1 XU Bingzhu2 LI Jianyu3
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| Abstract: |
| OBJECTIVE To discuss the research and control of diastereoisomeric impurities in synthetic peptide drugs development. METHODS The racemic mechanisms during a peptide-bond-forming reation were introduced, recommendations were provided on quality control of synthetic materials, control of manufacturing process, and choice of analytical methods. RESULTS Diastereoisomers are important part of related substances in synthetic peptide drugs development. CONCLUSION More attention should be paid to the research and control of diastereoisomeric impurities. |
| Key words: synthetic peptides racemization diastereoisomers |
