Dermal drug delivery system elemental impurities testing laboratory
Drug Delivery

The Development of Cutaneous Limits for Elemental Impurities

Almac Group
Drug Delivery

Increased focus on raw materials as dermal absorption delivery systems grow.

With new guidelines in place, manufacturers of prescription and over-the-counter products need to determine elemental impurity levels to provide a full risk assessment.

With new guidelines in place, manufacturers of prescription and over-the-counter products need to determine elemental impurity levels to provide a full risk assessment.

Why Cutaneous Limits

Skin exposure differs from oral or parenteral routes, so dedicated limits are useful.

Risk Assessment

Evaluating raw materials and process contributions supports a defensible control strategy.

Harmonisation

Aligned expectations help manufacturers apply consistent standards.

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