FDA药品溶出方法数据库
(FDA-Recommended Dissolution Methods Database)
药品通用名称 剂型 USP溶出装置 速度 溶出介质 介质体积 建议取样时间(分钟) 更新日期
Sucralfate Suspension II (Paddle) 75 0.1N HCl/0.067 M KCl, pH 1.0 900 10, 20, 30 and 45 2006/03/04
Sucralfate Tablet II (Paddle) 75 0.1 N HCl/0.067 M KCl, pH 1.0 900 15, 30, 45, 60, 180, 240 and 480 2009/04/02
Sucroferric Oxyhydroxide Tablet (Chewable) II (Paddle) 50 0.1 N HCl 900 10, 15, 20, 30, 45 and 60 2017/11/02
Sufentanil Citrate Tablet (Sublingual) II (Paddle) 50 pH 4.5 Acetate Buffer 50 2, 4, 8, 12 and 15 2022/05/12
Sulfadiazine Tablet Refer to USP 2008/07/14
Sulfamethoxazole/Trimethoprim Tablet Refer to USP 2008/01/14
Sulfamethoxazole/Trimethoprim Suspension II (Paddle) 50 1 mL of 0.2 N HCl in water 900 10, 20, 30, 45, 60 and 90 2004/02/25
Sulfasalazine Tablet Refer to USP 2009/12/15
Sulfasalazine Tablet (Delayed Release) Refer to USP 2009/12/15
Sulfisoxazole Acetyl Oral Suspension (Pediatric) II (Paddle) 30 1% SLS in 0.1N HCl 900 15, 30, 45, 60 and 90 2006/08/17
Sumatriptan Succinate Tablet Refer to FDA's Dissolution Guidance, 2018 2020/07/02
Sunitinib Malate Capsule Refer to FDA's Dissolution Guidance, 2018 2020/07/02
Suvorexant Tablet Develop a dissolution method 2023/09/15
Tacrolimus Capsule II (Paddle) 50 Hydroxypropyl Cellulose Solution (1 in 20,000). Adjust to pH 4.5 by Phosphoric Acid 900 30, 60, 90 and 120 2004/02/20
Tacrolimus For Suspension II (Paddle) 50 Hydroxypropyl Cellulose Solution (1 in 20,000). Adjust to pH 4.5 by Phosphoric Acid 15, 30, 45, 60, 90 and 120 2023/02/09
Tacrolimus Tablet (Extended Release) II (Paddle) 100 0.005% HPC in Water with 0.50% SLS adjusted to pH 4.5 900 0.5, 1, 2.5, 4.5, 6.5, 8.5 and 12 hours 2016/06/30
Tadalafil Tablet II (Paddle) 50 0.5% Sodium Lauryl Sulfate 1000 10, 20, 30 and 45 2006/01/26
Tafamidis Capsule II (Paddle) with sinker 75 Tier 1 Medium: 0.05M Sodium Phosphate Buffer, pH 6.8 with 1.0% Tween 80; Tier II Medium: 0.05M Sodium Phosphate Buffer, pH 6.8 with 1.0% Tween 80 and enzyme with protease activity as per USP 900 5, 10, 15, 20, 30 and 45 2021/04/22
Tafamidis Meglumine Capsule II (Paddle) with sinker 75 Tier 1 Medium: 0.05M Sodium Phosphate Buffer, pH 6.8. Tier 2 Medium: 0.05M Sodium Phosphate Buffer, pH 6.8, and pancreatin with protease activity as per USP 900 5, 10, 15, 20, 30 and 45 2021/04/22
Tafenoquine Succinate Tablet II (Paddle) 75 0.01M Sodium phosphate buffer, pH 6.8, with 0.20% w/v of Polysorbate 20 900 5, 10, 20, 30, 45 and 60 2020/08/27

数据库说明:

当前数据更新日期:2025年01月11日。
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