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
Buprenorphine
Film, Transdermal (Extended Release)
VI (Cylinder) with adapter, if needed
50
0.9% Sodium Chloride at 32°C
600
0.5,1, 2, 4, 6, 8,12, 16 and 24 hours
05/09/2013
Buprenorphine HCl
Implant
II (Paddle
50
Water
900
1, 4, 12, 24, 36, 48, 72, 96, 120, 144 and 168 hours
07/28/2016
Buprenorphine HCl
Film (Buccal)
I (Basket) 100 mL round bottom vessel
100
0.05M NaH2PO4.H2O Phosphate Buffer, pH 4.5
60
10, 15, 20, 30, 45 and 60
10/20/2016
Buprenorphine HCl
Tablet (Sublingual)
I (Basket)
100
Water
500
2, 5, 8, 10, 15, and until at least 80% of the labeled content is dissolved
04/09/2007
Buprenorphine HCl/Naloxone HCl
Film (Sublingual)
V (Paddle over Disk) with 56 mm, 40 mesh stainless steel disk.
100
Acetate Buffer, pH 4.0 (12.5mM Sodium acetate trihydrate and 60mM glacial acetic acid. Adjust the pH with glacial acetic acid or ammonium hydroxide).
900
1, 2, 3, 5, 7 and 10
10/31/2013
Buprenorphine HCl/Naloxone HCl
Tablet (Sublingual)
I (Basket)
100
Water
500
1, 3, 5, 7.5, 10, 15 and 20
07/01/2010
Bupropion HCl
Tablet (Extended Release)
Refer to USP
07/25/2007
Bupropion HCl
Tablet
Refer to FDA's Dissolution Guidance, 2018
07/02/2020
Bupropion Hydrobromide
Tablet (Extended Release)
I (Basket)
75
0.1 N HCl
900
1, 2, 4, 6, 8 and 10 hours
06/10/2009
Buspirone Hydrochloride
Tablet
Refer to FDA's Dissolution Guidance, 2018
07/02/2020
Busulfan
Tablet
Refer to FDA's Dissolution Guidance, 2018
07/02/2020
Busulfan
Tablet
II (Paddle)
50
Water (Deaerated)
500
5, 10, 15 and 30
07/14/2008
Cabergoline
Tablet
Refer to FDA's Dissolution Guidance, 2018
07/02/2020
Cabozantinib S-Malate
Tablet
II (Paddle
75
0.01 N HCl with 0.375% Triton X-100 (degassed)
900
5, 10, 15, 20 and 30
07/28/2016
Cabozantinib S-Malate
Capsule
II (Paddle) with sinker
75
0.01 N HCl with 0.5% Triton X-100 (degassed)
900
5, 10, 15, 20 and 30
06/02/2016
Calcifediol
Capsule (Extended Release)
II (Paddle) with sinker
75
0.5% SDS in 5 mM Sodium Dihydrogenphosphate Monohydrate, pH 6.8
500
1, 2, 4, 6, 8, 10 and 12 hours
10/20/2016
Calcitriol
Capsule
Develop a quantitative rupture test
06/03/2008
Calcium Acetate
Capsule
Refer to FDA's Dissolution Guidance, 2018
07/02/2020
Calcium Acetate
Tablet
Refer to FDA's Dissolution Guidance, 2018
07/02/2020
Calcium Acetate
Tablet
Refer to USP
01/14/2008