As a general rule preservatives (both chemical, i.e. antioxidants and
antimicrobial) and any excipients that may have a significant biological
activity, e.g. alcohol in topical drug products, must be controlled in the
finished product. The only difference relative to the control of the active
is that the acceptance criteria should take into account the use of the
excipients in the drug product, e.g. an antioxidant is normally consumed
during storage.
Frederic Ivanow
Head of Dossier Management, Galderma R&D
Frederic.ivanow@galderma.com
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