| Boceprevir |
Capsule |
II (Paddle) with sinker |
50 |
50 mM phosphate buffer, pH 6.8 with 0.1% sodium dodecyl sulfate |
900 |
10, 20, 30, 45, 60 and 75 |
2013/01/31 |
| Bosentan |
Tablet |
|
|
Develop a dissolution method |
|
|
2023/09/15 |
| Bosentan |
Tablet (For Suspension) |
II (Paddle) |
75 |
0.1 N HCl with 0.5% sodium dodecyl sulfate (SDS), pH 1.1 |
900 |
5, 10, 15, 20 and 30 |
2017/11/16 |
| Bosutinib Monohydrate |
Capsule |
II (Paddle) |
50 |
0.1 N HCl |
900 |
5, 10, 15, 20, 30, 45 and 60 |
2026/05/22 |
| Bosutinib Monohydrate |
Tablet |
II (Paddle) |
50 |
0.1 N HCl |
900 |
10, 15, 20, 30 and 45 |
2015/06/25 |
| Brensocatib |
Tablet |
|
|
Refer to FDA's Dissolution Guidance, 2018 |
|
|
2026/05/22 |
| Brexpiprazole |
Tablet |
II (Paddle) |
50 |
0.05 M Acetate buffer, pH 4.3 |
900 |
10, 15, 20, 30 and 45 |
2016/10/20 |
| Brigatinib |
Tablet |
II (Paddle) |
70 |
50 mM Potassium Phosphate Buffer, pH 7.2 |
900 |
5, 10, 15, 20, 30 and 45 |
2017/11/02 |
| Brimonidine Tartrate/Brinzolamide |
Ophthalmic Suspension |
|
|
Develop a method to characterize in vitro release |
|
|
2015/01/15 |
| Brincidofovir |
Tablet |
I (Basket) |
50 |
50 mM sodium phosphate buffer, pH 6.4 + 0.3% SDS |
900 |
5, 10, 15, 20, 30, 45, 60, 75 and 90 |
2023/07/07 |
| Brincidofovir |
Suspension |
II (Paddle) |
50 |
0.05 M Sodium Phosphate Monobasic, Monohydrate Buffer, pH 6.4 + 0.05% Tween 80 |
900 |
5, 10, 15, 20, 30, 45, 60, 75 and 90 |
2023/07/07 |
| Brinzolamide |
Ophthalmic Suspension |
|
|
Develop a method to characterize in vitro release |
|
|
2011/09/01 |
| Brivaracetam |
Tablet |
II (Paddle |
50 |
Phosphate Buffer, pH 6.4 |
2.5 and 5 mg tablets: 500 mL; 10, 25, 50, 75 and 100 mg tablets: 900 mL |
5, 10, 15, 20 and 30 |
2016/07/28 |
| Bromocriptine Mesylate |
Capsule |
I (Basket) |
75 |
0.1 N HCl |
500 |
5, 10, 15, 20, 30, 45 and 60 |
2026/05/22 |
| Bromocriptine Mesylate |
Tablet |
|
|
Refer to USP |
|
|
2007/07/25 |
| Budesonide |
Tablet (Extended Release) |
II (Paddle) |
100 |
Acid Stage: 0.1 M HCl containing
0.5% Macrogol Cetostearyl Ether; Buffer Stage: pH 7.2 phosphate buffer containing 0.5% Macrogol
Cetostearyl Ether. |
Acid Stage: 500 mL ; Buffer Stage: 1000 mL |
Acid Stage: 2 hours; Buffer Stage: 1, 2, 4, 6, 8 and 10 hours |
2015/04/02 |
| Budesonide |
Capsule |
II (Paddle) with sinker |
75 |
Acid stage: 0.1 N HCl; Buffer stage: Phosphate Buffer, pH 7.5 |
Acid stage: 1000; Buffer stage: 1000 |
Acid stage: 2 hours; Buffer stage: 0.25, 0.5, 1, 2, 4, 6 and 8 hours |
2015/02/25 |
| Budesonide |
Suspension |
II (Paddle) |
50 |
0.25% SDS in 0.009 N HCl |
500 |
5, 10, 15, 20, 30, 45 and 60 |
2026/01/28 |
| Bumetanide |
Tablet |
|
|
Develop a dissolution method |
|
|
2024/01/03 |
| Bupivacaine |
Solution (Extended Release), Infiltration |
II (Paddle) |
50 |
0.025 M Sodium Phosphate Buffer with 0.03% Sodium Dodecyl Sulfate (SDS), pH 7.4 |
900 |
1, 2, 4, 8, 12, 16, 24, 36 and 48 hours |
2022/07/07 |