Module 3 - Strategic case studies in practice

Any Additives - Antioxidants and Preservatives?

Note for Guidance (Excipients, antioxidants and preservatives)…  The reason for inclusion  Proof of efficacy  Method of control in the DP  Details of the labelling  …and the physical and chemical compatibility of the antioxidant and preservative with other constituents of the drug product, container and closure

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