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- Sampling time recommendations during fasted state gastrointestinal dissolution testing
Sampling time recommendations during fasted state gastrointestinal dissolution testing
Recommended sampling time points for a formulation that has not previously been explored in the fasted state biorelevant medium are:
For FaSSGF: 5, 10, 20, 30, 45, 60, 90 minutes
For FaSSIF: 5, 10, 20, 30, 45, 60, 90, 120, and 180 minutes
These time points help evaluate how the drug product behaves (dissolution and stability) in the biorelevant medium over physiologically relevant time frames. For immediate-release dosage forms, carefully observe and record the disintegration behaviour during the first 2 to 3 minutes.
