Case Studies

The Development of Cutaneous Limits for Elemental Impurities

As interest grows in drugs that are delivered using a dermal absorption delivery system, there is increased focused on raw materials.

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Released By Almac Group

As interest grows in drugs that are delivered using a dermal absorption delivery system, there is increased focused on raw materials. As with all drug products, the raw materials used in the manufacture of the drug substance and the drug product itself must be rigorously tested prior to selling in different global markets.

With these new guidelines in place, it is in the interest of harmonisation that manufacturers of both prescription and over-the-counter products determine the levels of elemental impurities to provide a full and detailed risk assessment to regulators. Industries in both ICH and non-ICH regions are beginning to express interest in the risk associated with new drug products that use a dermal adsorption delivery system.

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