According toUSP, the breaking or separation of an oil phase that is not easily dispersed is indicative of a reaction in a(n):
Tincture
Solution
Suspension
Emulsion
Emulsionsaremixtures of two immiscible liquids (e.g., oil and water) stabilized by an emulsifying agent.
When an emulsion breaks (phase separation occurs), the oil and water separate permanently, rendering the medication unusable.
Why Other Options Are Incorrect:
A. Tinctures?❌Alcohol-based solutions with dissolved drug, no phase separation occurs.
B. Solutions?❌Homogeneous mixtures that do NOT separate.
C. Suspensions?❌May settle over time but can be re-mixed by shaking.
????Reference:USP <795> Compounded Dosage Forms, PTCE Compounding Guidelines.
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