羧甲司坦中杂质的分离和鉴定
Separation and identification of impurities in carbocisteine
分类号：
出版年·卷·期（页码）：2014,34 (4):0-0
DOI:
10.16155/j.0254-1793.2017.01.01
-----摘要：-------------------------------------------------------------------------------------------
目的：分离和鉴定羧甲司坦中的杂质。 方法： 采用离子对HPLC法分析羧甲司坦中的有机杂质。通过与对照品比较，鉴定了其中的3个杂质；合成了其中1个无对照品的未知杂质，并采用MS和NMR对其结构进行鉴定。 结果： 确定了羧甲司坦中的4个有机杂质分别为氯乙酸、胱氨酸、羧甲基半胱氨酸内酰胺和N，S-（二羧甲基）半胱氨酸。 结论： N，S-（二羧甲基）半胱氨酸是羧甲司坦的合成副产物，为首次报道。
-----英文摘要：---------------------------------------------------------------------------------------
Objective: To separate and identify impurities in carbocisteine. Methods: Reversed phase ion-pair chromatography was adopted to analyze organic impurities in carbocisteine.Three impurities were identified when compared with standard substances;another impurity was synthesized and identified by NMR and MS. Results: Four impurities of carbocisteine were confirmed to be chloroacetic acid,cystine,lactam of (s)-carboxymethyl-L-cysteine and N,S-dicarboxymethyl-cysteine. Conclusion: N,S-dicarboxymethyl-cysteine as a synthesis by-product of carbocisteine was first reported.
-----参考文献：---------------------------------------------------------------------------------------
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