| Baricitinib |
Tablet |
II (Paddle) |
75 |
Acetate buffer pH 4.5 |
900 |
5, 15, 30, 45 |
2023/03/30 |
| Bedaquiline Fumarate |
Tablet |
I (Basket) |
150 |
0.01 N HCl |
900 |
10, 15, 20, 30 and 45 |
2013/06/06 |
| Belzutifan |
Tablet |
II (Paddle) |
50 |
50 mM potassium phosphate buffer at pH 6.5 with 68 mM potassium chloride (@37°C) |
900 |
10, 15, 20, 30, 45 and 60 |
2023/07/07 |
| Bempedoic Acid |
Tablet |
II (Paddle) |
50 |
0.05 M Phosphate buffer, pH 6.6 |
900 |
5, 10, 15, 20 and 30 |
2021/08/19 |
| Bempedoic Acid/Ezetimibe |
Tablet |
II (Paddle) |
50 |
Bempedoic Acid: 0.05 M Phosphate buffer, pH 6.6; Ezetimibe: 0.05M Sodium
Acetate Buffer pH 4.5 with 0.45% SLS |
900 |
5, 10, 15, 20, 30, and 45 |
2021/08/19 |
| Benazepril HCl |
Tablet |
|
|
Develop a dissolution method |
|
|
2023/09/15 |
| Benazepril HCl/Hydrochlorothiazide |
Tablet |
I (Basket) |
100 |
0.1 N HCl |
500 |
10, 20, 30 and 45 |
2004/01/16 |
| Bendroflumethiazide/Nadolol |
Tablet |
|
|
Refer to USP |
|
|
2007/07/25 |
| Benzgalantamine Gluconate |
Tablet, Delayed Release |
I (Basket) |
50 |
Acid Stage: 0.1N HCl; Buffer Stage: 0.05M Sodium Phosphate buffer pH 6.8 with 0.5% SDS |
1000 |
Acid stage: 120; Buffer stage: 15, 20, 30, 45, 60 and 75 |
2025/06/23 |
| Benzonatate |
Capsule |
|
|
Develop a dissolution method |
|
|
2024/01/03 |
| Benzoyl Peroxide; Clindamycin Phosphate |
Gel |
|
|
Develop a method to characterize in vitro release |
|
|
2023/05/18 |
| Benzphetamine HCl |
Tablet |
|
|
Refer to FDA's Dissolution Guidance, 2018 |
|
|
2020/07/02 |
| Bepridil HCl |
Tablet |
I (Basket) |
100 |
0.1 N HCl |
900 |
10, 20, 30, 45 and 60 |
2004/01/16 |
| Berotralstat HCl |
Capsule |
|
|
Refer to FDA's Dissolution Guidance, 2018 |
|
|
2023/02/09 |
| Betamethasone Acetate/Betamethasone Sodium Phosphate |
Injectable Suspension |
IV (Flow through cell) |
Flow @ 8 mL/min |
0.05% SLS, pH 3.0 or Develop an in vitro release method using USP IV (Flow-Through Cell), and, if applicable, Apparatus II (Paddle) or any other appropriate method, for comparative evaluation by the Agency |
|
5, 10, 15, 30, 45, 60, 90, 120, 180, 240, 300, and 360 |
2010/04/08 |
| Bethanechol Chloride |
Tablet |
|
|
Refer to FDA's Dissolution Guidance, 2018 |
|
|
2020/07/02 |
| Bethanechol Chloride |
Tablet |
|
|
Refer to USP |
|
|
2008/10/06 |
| Betrixaban |
Capsule |
|
|
Refer to FDA's Dissolution Guidance, 2018 |
|
|
2020/07/02 |
| Bexagliflozin |
Tablet |
I (Basket) |
50 |
0.1 N HCl |
900 |
1, 3, 5, 8 and 10 hours |
2024/05/31 |
| Bexarotene |
Capsule |
II (Paddle) |
50 |
Tier 1 Medium: 0.5% HDTMA in 0.05 M phosphate buffer, pH 7.5
Tier 2 Medium: 0.5% HDTMA in 0.05 M phosphate buffer, pH 7.5 with 0.05 g/L pancreatin enzyme |
900 |
15, 30, 45 and 60 |
2006/08/17 |