AAC  >> Vol. 6 No. 3 (August 2016)

    Review on Analysis of Related Structure Impurities in Synthetic Peptide Medicines

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陈松辉,陈 妍:国家精细化学品质量监督检验中心,泰州市产品质量监督检验所,江苏 泰州 ;
李 明,李红梅:中国计量科学研究院,化学计量与分析科学研究所,北京

多肽药物杂质质量控制质谱综述Peptide Medicine Impurity Quality Control Mass Spectrometry Review



Peptide medicines have been widely used because of the advantages of relatively low cost, high biological activity, low side effects, target specificity, etc. At present, the peptide drug market is growing twice as fast as other drug markets. Currently, most of the peptides are manufactured by solid-phase peptide synthesis. During synthesis and transportation process, related structure im-purities such as amino acid deletion, amino acid insertion, incomplete removal of protecting groups, oxidation/reduction are easily generated. Many related structure impurities don’t have therapeutic effect; on the contrary they have toxic and side effect. In the paper, the analysis of related structure impurities in synthetic peptide medicines is systematically reviewed. This will be helpful to establish related regulation on quality control of medicine and improve quality of peptide medicine.

陈松辉, 李明, 李红梅, 陈妍. 合成多肽药物中相关结构杂质分析综述[J]. 分析化学进展, 2016, 6(3): 43-50. http://dx.doi.org/10.12677/AAC.2016.63007


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