The pH range for dissolution, particularly in the context of simulating physiological conditions for drug testing, is typically 1.2 to 6.8.
This pH range is used to mimic the varying acidity levels found in the gastrointestinal tract, allowing for evaluation of how a drug dissolves under different conditions. Here's a more detailed breakdown:
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pH 1.2: This simulates the highly acidic environment of the stomach.
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pH 6.8: This is used to simulate intestinal fluid (SIF), representing a more neutral or slightly acidic environment found in the small intestine.
The use of this pH range in dissolution testing helps predict how a drug will behave in the body and ensures its effectiveness and safety. The ionic strength of the buffers used should be the same as in the United States Pharmacopeia (USP).
