FDA溶出度方法库2730条
药品名称
剂型
USP溶出方法
转速（转/min）
溶出介质
容积
荐采样时间
更新时间
Estradiol
Vaginal Tablet
I (Basket)
40
Phosphate Buffer, pH 4.75 ± 0.05
500
1, 2, 3, 5, 8, 10 and 12 hours
07/21/2009
Estradiol
Vaginal Ring
Incubator shaker
130
0.9% Saline
250
1, 9, 16, 17, 18, 19, 45 days
01/03/2007
Estradiol (0.014 mg/24 hr)
Film, Transdermal (Extended Release)
Develop a method to characterize in vitro release
10/28/2010
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
10/28/2010
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
1, 2, 4, 6, 8, 10 and 12 hours
10/28/2010
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
10/28/2010
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
1, 2, 4, 6, 10, 12, 18, 24 and 36 hours
10/31/2013
Estradiol/Norethindrone Acetate
Tablet
Refer to USP
01/05/2012
Estradiol/Norgestimate (1mg/0.09mg)
Tablet
II (Paddle)
50
0.3% SLS in water
500
10, 20, 30 and 45
07/09/2004
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
01/30/2020
Estramustine Phosphate Sodium
Capsule
I (Basket)
100
Water
900
10, 20, 30 and 45
07/15/2009
Estrogens Conjugated Synthetic A
Tablet
I (Basket)
50
Water
900
1, 2, 3, 5, 8, 10 and 12 hours
09/02/2010
Estrogens, Conjugated (EC)/Medroxyprogesterone Acetate (MPA)
Tablet
II (Paddle) with sinker
50
EC: 0.02 M Na Acetate Buffer (pH 4.5); MPA: 0.54% Sodium Lauryl Sulfate [SLS] in water
900
12/24/2015
Estrogens, Conjugated Synthetic B
Tablet
II (Paddle)
50
Water
900
2, 5, 8 and 12 hours
10/06/2008
Eszopiclone
Tablet
Refer to FDA's Dissolution Guidance, 2018
07/02/2020
Ethacrynic Acid
Tablet
Refer to USP
12/23/2010
Ethambutol HCl
Tablet
Refer to USP
01/14/2008
Ethinyl Estradiol
Tablet
Refer to USP
09/22/2011
Ethinyl Estradiol/Ethynodiol Diacetate
Tablet
II (Paddle)
75
0.25% Sodium Lauryl Sulfate (SLS) in Water
600
10, 20, 30 and 45
07/14/2008
Ethinyl Estradiol/Etonogestrel
Vaginal Ring
Develop a method to characterize in vitro release
01/31/2013