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5 C high throughout the physiological pH range Dose/solubility 250 mL pH 1. 2 6. 8 H 1 2 - 6 8 General single-point dissolution acceptance criteria with a lower limit are acceptable YES Using ICH Guideline Is d I dosage form f dissolving rapidly Dissolution 80 /15min at pH 1. 2 4. 0 and 6. 8 Has a relationship been determined between General disintegration upper time limit are acceptable and dissolution per se...
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