| Dipyridamole |
Tablet |
|
|
Refer to USP |
|
|
2007/06/18 |
| Diroximel Fumarate |
Capsule (Delayed Release) |
II (Paddle) with sinker |
75 |
Acid Stage: 0.1 N HCl; Buffer Stage: Na.Phosphate Buffer, pH 6.5 |
|
Acid Stage: 120; Buffer Stage: 10, 20, 30, 45, 60, 75 and 90 |
2020/04/02 |
| Disopyramide Phosphate |
Capsule |
|
|
Develop a dissolution method |
|
|
2024/01/03 |
| Disopyramide Phosphate |
Capsule (Extended Release) |
|
|
Refer to USP |
|
|
2008/11/04 |
| Disulfiram |
Tablet |
II (Paddle) |
100 |
2% SDS |
900 |
15, 30, 45, 60, 75, 90, 105, and 120 |
2007/06/18 |
| Divalproex Sodium |
Tablet (Delayed Release) |
|
|
Refer to USP |
|
|
2007/07/25 |
| Divalproex Sodium |
Tablet (Extended Release) |
|
|
Refer to USP |
|
|
2016/06/30 |
| Divalproex Sodium |
Capsule (Delayed Release) |
|
|
Refer to USP |
|
|
2016/06/30 |
| Dofetilide |
Capsule |
|
|
Refer to FDA's Dissolution Guidance, 2018 |
|
|
2020/07/02 |
| Dolasetron Mesylate |
Tablet |
|
|
Develop a dissolution method |
|
|
2024/01/03 |
| Dolutegravir Na/Rilpivirine HCl |
Tablet |
II (Paddle) |
75 |
1.0 % Tween 20 in 0.01 M HCl, pH 2.0 |
900 |
10, 15, 20, 30, 45 and 60 |
2018/02/08 |
| Dolutegravir Sodium (10 mg) |
Tablet |
II (Paddle) |
50 |
0.01M pH 6.8 phosphate buffer |
900 |
5, 10, 15, 20, 30 and 45 |
2018/10/18 |
| Dolutegravir Sodium (25 mg) |
Tablet |
II (Paddle) |
50 |
0.01M pH 6.8 phosphate buffer containing 0.15% w/v sodium dodecyl sulfate (SDS) |
900 |
5, 10, 15, 20, 30 and 45 |
2018/10/18 |
| Dolutegravir Sodium (50 mg) |
Tablet |
II (Paddle) |
50 |
0.01M pH 6.8 phosphate buffer containing 0.25% w/v sodium dodecyl sulfate (SDS) |
900 |
5, 10, 15, 20, 30 and 45 |
2018/10/18 |
| Donepezil HCl/Memantine HCl |
Capsule (Extended Release) |
I (Basket) |
100 |
pH 1.2 NaCl/HCl buffer |
900 |
Donepezil: 5, 10, 15, 20 and 30 minutes; Memantine: 1, 2, 3, 4, 6, 8, 10 and 12 hours |
2015/05/28 |
| Donepezil HCl |
Tablet (Orally Disintegrating (ODT)) |
II (Paddle) |
50 |
0.1 N HCl |
900 |
10, 20, 30 and 45 |
2006/03/04 |
| Donepezil HCl |
Tablet |
|
|
Refer to FDA's Dissolution Guidance, 2018 |
|
|
2020/07/02 |
| Donepezil HCl |
Transdermal |
V (Paddle over disk) with Transdermal System Holding Wire Screen (TSHWR) |
100 |
0.02 M sodium acetate buffer, pH 4.5 at 32°C |
900 |
1,8,24,48 and 168 hours |
2023/05/18 |
| Donepezil HCl (23 mg) |
Tablet |
II (Paddle |
50 |
0.05 M Phosphate Buffer, pH 6.8 |
900 |
1, 2, 3, 4, 6, 8 and 10 hours |
2010/12/23 |
| Doravirine/Lamivudine/Tenofovir Disoproxil Fumarate |
Tablets |
II (Paddle) |
75 |
25 mM Phosphate Buffer, pH 6.8 with 3% Polysorbate 80 |
900 |
5, 10, 15, 20, 30, 45, 60 and 90 |
2023/10/06 |
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