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Guidance required for :Allowable Excess Volume/Content in Injectable Drug

  • 1.  Guidance required for :Allowable Excess Volume/Content in Injectable Drug

    Posted 22-Dec-2023 04:50

    Hi all,

    For Generic lyophilized powder for Injection product ,if RLD label says reconstitute with 2.5ml water, Do we need to add gross content as part of specification as per MAPP 5019.1 Allowable Excess Volume/Content in Injectable Drug and Biological Products?

    Regards,

    Sapna



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    sapna rathi
    Regulatory specialist
    AHME
    India
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