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。
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.
出处
《中国现代应用药学》
CAS
CSCD
北大核心
2010年第5期387-389,共3页
Chinese Journal of Modern Applied Pharmacy
关键词
合成多肽
消旋
非对映异构体
synthetic peptides
racemization
diastereoisomers
