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Abstract

Isolation and characterization of process-related impurity inMephenytoin

Author(s): Krishnamoorthy Balamurugan, Kannan Gokulakrishnan

One unknown impurity inMephenytoin bulk material at a level 0.15% was detected by a reverse phase high performance liquid chromatography (HPLC). This impurity was isolated from a crude sample of Mephenytoin using reverse phase preparative LC. The impurity isolated by preparative LC was characterized by IR, NMR, MS experimental data. Based on the results obtained from different spectroscopic experiments, these impurity was characterized as 1, 3-Dimethyl-5, 5-phenylethyl hydantoin. Formation of this impurity is also discussed.


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Organic Chemistry: An Indian Journal received 565 citations as per Google Scholar report

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