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
Sertraline HCl Capsule II (Paddle) with sinker 75 0.1 N HCl 900 10, 15, 20, 30 and 45 2023/07/07
Sertraline HCl Tablet II (Paddle) 75 0.05 M Sodium Acetate Buffer, pH 4.5 900 10, 20, 30 and 45 2004/02/20
Sevelamer Carbonate Tablet Disintegration Testing in 0.1 N HCl as per USP <701> 2008/10/06
Sevelamer HCl Capsule Disintegration Testing in 0.1 N HCl as per USP <701> 2008/04/09
Sevelamer HCl Tablet Disintegration Testing in 0.1 N HCl as per USP <701> 2008/04/09
Sibutramine HCl Capsule II (Paddle) 50 0.05 M Acetate Buffer, pH 4.0 500 10, 20, 30, 45 and 60 2004/02/25
Sildenafil Citrate Tablet I (Basket) 100 0.01 N HCl 900 5, 10, 15 and 30 2006/03/04
Sildenafil Citrate Suspension II (Paddle) 50 McIlvaine Buffer, pH 5.0 500 5, 10, 15, 20 and 30 2015/05/28
Silodosin Capsule Refer to FDA's Dissolution Guidance, 2018 2020/07/02
Simeprevir Sodium Capsule II (Paddle) 75 0.05 M Phosphate Buffer, pH 6.8 with 1.0% polysorbate 20 900 10, 15, 20, 30 and 45 2015/05/28
Simvastatin Suspension II (Paddle) 50 Phosphate Buffer, pH 7.0, with 0.14% sodium dodecyl sulfate (SDS) 900 10, 15, 20, 30 and 45 2016/12/22
Simvastatin Tablet Refer to USP 2007/06/18
Simvastatin Tablet (Orally Disintegrating) II (Paddle) 75 0.15% SDS Buffer, pH 6.8 900 5, 10, 15 and 30 2008/09/03
Siponimod Fumaric Acid Tablet II (Paddle) 50 Phosphate Buffer, pH 6.8 with 0.1% (m/v) Polysorbate 80 900 mL [for 2 mg strength] 500 mL [for 0.25 mg strength] 5, 10, 15, 20 and 30 2021/08/19
Sirolimus Tablet Develop a dissolution method 2023/09/15
Sirolimus Gel Develop a method to characterize in vitro release 2023/05/18
Sitagliptin Phosphate Tablet Refer to FDA's Dissolution Guidance, 2018 2020/07/02
Sitagliptin Phosphate/Simvastatin Tablet II (Paddle) with stainless steel stationary quadrangular hanging basket 100 10 mM Sodium phosphate buffer containing 1% Tween 80 with 50 μg/mL Butylated hydroxyanisole 900 5, 10, 15, 20, 30, and 45 2013/10/31
Sodium Iodide I-123 Capsule Develop a dissolution method 2023/09/15
Sodium Iodide I-131 Capsule Develop a dissolution method 2022/07/07

数据库说明:

当前数据更新日期:2025年06月27日。
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