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
Esomeprazole Magnesium Tablet (Delayed Release) II (Paddle) 100 Acid stage: 0.1 N HCl; Buffer stage: Phosphate Buffer, pH 6.8 Acid stage: 300; Buffer stage: 1000 Acid stage: 120; Buffer stage: 10, 20, 30, 45 and 60 2016/10/20
Estazolam Tablet Develop a dissolution method 2023/09/15
Esterified Estrogens Tablet Develop a dissolution method 2023/09/15
Estradiol Vaginal Insert III (Reciprocating Cylinder) 30 dips/min 0.1 N HCl with 0.5% SLS 250 30, 60, 90 and 120 2024/11/01
Estradiol Vaginal Tablet I (Basket) 40 Phosphate Buffer, pH 4.75 ± 0.05 500 1, 2, 3, 5, 8, 10 and 12 hours 2009/07/21
Estradiol Vaginal Ring Incubator shaker 130 0.9% Saline 250 1, 9, 16, 17, 18, 19, 45 days 2007/01/03
Estradiol (0.014 mg/24 hr) Film, Transdermal (Extended Release) Develop a method to characterize in vitro release 2010/10/28
Estradiol (0.025 mg/24 hr, 0.0375 mg/24 hr, 0.05 mg/24 hr, 0.06 mg/24 hr, 0.075 mg/24 hr and 0.1 mg/24 hr) Film, Transdermal (Extended Release) Develop a method to characterize in vitro release 2010/10/28
Estradiol (Test 1) (0.025 mg/24 hr, 0.0375 mg/24 hr, 0.05 mg/24 hr, 0.075 mg/24 hr and 0.1 mg/24 hr) Film, Transdermal (Extended Release) VI (Cylinder) attach the patch to a disk at the bottom of the cylinder 50 Water at 32 ± 0.5°C 0.025 mg/24 hr and 0.0375 mg/24 hr: 500 mL; 0.05 mg/24 hr, 0.075 mg/24 hr and 0.1 mg/24 hr: 900 mL 1, 2, 4, 6, 8, 10 and 12 hours 2010/10/28
Estradiol (Test 2) (0.05 mg/24 hr and 0.1 mg/24 hr) Film, Transdermal (Extended Release) V (Paddle over Disk) with a stainless steel disk 50 Water at 32 ± 0.5°C 900 6, 12, 18, 24, 36, 48, 60, 72 and 96 hours 2010/10/28
Estradiol (Test 3) 0.0375 mg/24 hr, 0.05 mg/24 hr, 0.075 mg/24 hr and 0.1 mg/24 hr) Film, Transdermal (Extended Release) VI (Cylinder) attach the patch to the cylinder with double-sided tape 50 Water at 32 ± 0.5°C 0.0375 mg/24 hr: 500 mL; 0.05 mg/24 hr, 0.075 mg/24 hr and 0.1 mg/24 hr: 900 mL 1, 2, 4, 6, 10, 12, 18, 24 and 36 hours 2013/10/31
Estradiol/Levonorgestrel Film, Transdermal (Extended Release) V (Paddle over Disk) attach the patch to the stainless steel plate with double-sided tape 50 30% Ethanol in water at 32±0.5°C 660 30, 60, 120, 180, 240 and 300 2023/03/30
Estradiol/Norethindrone Acetate Film, Transdermal (Extended Release) V (Paddle over Disk) 50 0.24% SDS in water at 32±0.5°C 0.05 mg/0.14 mg/24 hr: 500; 0.05mg/0.25 mg/24 hr: 900 1, 2, 4, 8, 12 and 14 hours 2023/03/30
Estradiol/Norethindrone Acetate Tablet Develop a dissolution method 2024/01/03
Estradiol/Norgestimate (1mg/0.09mg) Tablet Develop a dissolution method 2023/09/15
Estradiol/Progesterone Capsule III (Reciprocating Cylinder) [40 mesh for bottom and top of the inner tube] 3% sodium lauryl sulfate (SLS) in 0.1N HCl 250 10, 20, 30, 45 and 60 2020/01/30
Estramustine Phosphate Sodium Capsule Develop a dissolution method 2023/09/15
Estrogens Conjugated Synthetic A Tablet Develop a dissolution method 2023/09/15
Estrogens, Conjugated (EC)/Medroxyprogesterone Acetate (MPA) Tablet II (Paddle) with sinker 50 EC: 0.02 M Na Acetate Buffer (pH 4.5); MPA: Develop a dissolution method 900 2023/09/15
Estrogens, Conjugated Synthetic B Tablet Develop a dissolution method 2023/09/15

数据库说明:

当前数据更新日期:2025年12月14日。
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