
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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