USP哪些项目溶出介质为0.1M HCL中加SDS的？1. Divalproex sodium Tablet (Extended Release) II (Paddle) 100 Acid phase: 0.1 N HCl for 45 minutes; Drug Release: (after 45 minutes) 0.05 M Phosphate Buffer with 75 mM SDS, pH 5.5 Acid phase:500 mL; Drug release: 900 mL 1.5, 3, 6, 9, 12, 15, 18, 21 and 24 hours 2. Dutasteride Capsule (Soft-Gelatin) II (Paddle) 50 Tier I: Dissolution Medium: 0.1 N HCI with 2% (w/v) sodium dodecyl sulfate (SDS) (900 mL) Tier II: Dissolution Medium: 0.1 N HCI with pepsin (as per USP) (450 mL) for the first 25 minutes, followed by addition of 0.1 N HCI with SDS (4% w/v) (450 mL) for the remainder of the dissolution test. 900 15, 30, 45 and 60 min 3. Erlotinib HCl Tablet II (Paddle) 75 0.1 N HCl containing 1% SDS 1000 15, 30, 45 and 60 min 4. Ezetimibe/Simvastatin Tablet II (Paddle) 50 0.01 M Sodium Phosphate, pH 7.0/0.5% SDS 900 5, 10, 20 and 30 min 5. Fingolimod Capsule I (Basket) 100 0.1 N HCl with 0.2% SDS (sodium dodecyl sulfate) 500 5, 10, 15, 20 and 30 min 6 Sorafenib Tosylate Tablet II (Paddle) 75 0.1 M HCl with 1% SDS 900 5, 10, 15, 20 and 30 min查看更多
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