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Residual solvent in drug substance

  • 1.  Residual solvent in drug substance

    This message was posted by a user wishing to remain anonymous
    Posted 17-Mar-2022 10:30
    This message was posted by a user wishing to remain anonymous

    Hi All,

    How to determine the permissible daily exposure for a solvent which is not included in the ICH Q3C guideline for drug substance to be used to manufacture phase 2 drug product. Also, no toxicological data is available on literature search.