Impurities in Finasteride: Identification, Synthesis, Characterization and Control of Potential Carry-Over Impurities from Reagents Used for the Process

    January 2014 in “ Asian Journal of Chemistry ”
    Sandeep Mohanty, B. Pavan Kumar, Arun Karmakar
    TLDR Two impurities in finasteride were identified and characterized as cyclohexyl and phenyl analogs.
    The document assessed the impurity profile of finasteride, focusing on potential carry-over impurities from reagents used in its synthesis. Impurities in the reaction mass were monitored using HPLC, and potential impurities were isolated with preparative HPLC. Their structures were confirmed through 1H NMR, MS, and MS-MS. The study identified and characterized two impurities as cyclohexyl and phenyl analogs of finasteride, providing insights into the synthesis process and impurity control.
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