Determination of the Source of the N-Methyl Impurity in the Synthesis of Pemetrexed Disodium Heptahydrate

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• 作者：Douglas P. Kjell ; Dallas W. Hallberg ; J. Michael Kalbfleisch ; Cynthia K. McCurry ; Michael J. Semo ; Edward M. Sheldon ; Jeremy T. Spitler ; and Ming Wang
• 刊名：Organic Process Research & Development
• 出版年：2005
• 出版时间：November 2005
• 年：2005
• 卷：9
• 期：6
• 页码：738 - 742
• 全文大小：75K
• 年卷期：v.9,no.6(November 2005)
• ISSN：1520-586X

文摘

The synthesis of Pemetrexed Disodium Heptahydrate hasconsistently resulted in a very low level (ca. 0.02%) unknownimpurity. To ensure long-term control, the identity and sourceof the impurity were desired. Isolation and characterizationidentified the impurity as the N-methyl derivative. The sourcewas identified as the methyl groups on the peptide couplingagent, 2,6-Dimethoxy-1,3,5-triazine (CDMT). Further workassured the current conditions provide adequate control.