Active Ingredient

API

Definición

The component of a drug product that produces the intended therapeutic effect. The active pharmaceutical ingredient (API) is what the drug does — everything else in the formulation (binders, fillers, coatings) are inactive ingredients (excipients).

Ejemplo

In Tylenol Extra Strength, the active ingredient is acetaminophen 500 mg per tablet. The remaining mass consists of excipients.

Términos Relacionados

Excipient Generic Equivalence Inactive Ingredient

Mencionado en Guías

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