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| 药品名称 | 剂型 | USP 溶出方法 | 转速（转/min） | 溶出介质 | 容积 | 推荐采样时间 | 更新时间 | 查看详情 |
|---|---|---|---|---|---|---|---|---|
| Omega-3-Acid Ethyl Esters Type A | Capsule | Develop an in vitro release method using USP IV (Flow-Through Cell), and, if applicable, Apparatus II (Paddle) or any other appropriate pharmacopoeial apparatus, for comparative evaluation by the Agency. | 2025-09-08 | 查看 | ||||
| Nirogacestat Hydrobromide | Tablet | II (Paddle) | 75 | pH 1.2 HCl buffer | 500 | 5, 10, 15, 20, 30, 45 and 60 | 2025-09-08 | 查看 |
| Lumateperone Tosylate | Capsule | Refer to FDA's Dissolution Guidance, 2018 | 2025-09-08 | 查看 | ||||
| Glycopyrrolate | Tablet, Oral Disintegrating | Refer to FDA's Dissolution Guidance, 2018 | 2025-09-08 | 查看 | ||||
| Bupivacaine; Meloxicam | Solution, Extended Release | Develop a method to characterize in vitro release | 2025-09-08 | 查看 | ||||
| Ritonavir | Tablet | Develop a dissolution method | 2025-09-08 | 查看 | ||||
| Ibrutinib | Suspension | II (Paddle) | 25 | 0.05 M potassium phosphate buffer, pH 6.8, w/ 1.5% (w/v) Tween 20 | 900 | 5, 10, 15, 20, 30, 45 and 60 | 2025-09-08 | 查看 |
| Amantadine Hydrochloride | Capsule, Extended Release | Develop a dissolution method | 2025-09-08 | 查看 | ||||
| Clevidipine | Emulsion | Develop a dissolution method | 2025-09-08 | 查看 | ||||
| Metoprolol Succinate | Capsule, extended release | II (Paddle) | 50 | Phosphate buffer, pH 6.8 | 500 | 1, 4, 8, 12, 16, 20 and 24 hours | 2025-09-08 | 查看 |
| Vonoprazan Fumarate | Tablet | II (Paddle) | 50 | Acetate Buffer, pH 4.5 | 900 | 5, 10, 15, 20, 30, 45 and 60 | 2025-09-08 | 查看 |
| Fruquintinib | Capsule | II (Paddle) with sinker | 75 | Phosphate-buffered saline (PBS), pH 6.8, w/ 0.08% SLS | 900 | 5, 10, 15, 20, 30, 45 and 60 | 2025-09-08 | 查看 |
| Abiraterone Acetate; Niraparib Tosylate | Tablet | II (Paddle) | 75 | 0.05 M sodium phosphate buffer, pH 4.5, w/ 0.25% SLS | 900 | 5, 10, 15, 20, 30, 45 and 60 | 2025-09-08 | 查看 |
| Repotrectinib | Capsule | II (Paddle) with sinker | 75 | 50 mM Sodium Phosphate Buffer, pH 6.8, w/ 0.075% SLS | 900 | 5, 10, 15, 30, 45, 60 and 75 | 2025-06-23 | 查看 |
| Deutetrabenazine | Tablet, Extended Release | II (Paddle) with sinker | 75 | 50 mM Potassium Biphthalate pH 3.0 | 500 | 1, 2, 4, 6, 8, 10, 12, 16 and 20 hours | 2025-06-23 | 查看 |
| Zuranolone | Capsule | II (Paddle) with sinker | 75 | 50 mM Sodium Phosphate Buffer, pH 6.8, w/ 0.3% SDS | 900 | 10, 20, 30 and 45 | 2025-06-23 | 查看 |
| Norgestrel | Tablet | Refer to FDA's Dissolution Guidance, 2018 | 2025-06-23 | 查看 | ||||
| Benzgalantamine Gluconate | Tablet, Delayed Release | I (Basket) | 50 | Acid Stage: 0.1N HCl; Buffer Stage: 0.05M Sodium Phosphate buffer pH 6.8 with 0.5% SDS | 1000 | Acid stage: 120; Buffer stage: 15, 20, 30, 45, 60 and 75 | 2025-06-23 | 查看 |
| Gepirone Hydrochloride | Tablet, Extended Release | II (Paddle) | 50 | 0.01 N HCl | 900 | 1, 2, 4, 8, 10, 12, 14, 16, 18 and 20 hours | 2025-06-23 | 查看 |
| Migalastat Hydrochloride | Capsule | Refer to FDA's Dissolution Guidance, 2018 | 2025-06-23 | 查看 |
