| Deutetrabenazine |
Tablet |
II (Paddle) over a disk (62 mm with 16 mesh) |
75 |
pH 3.0 Acid Phthalate Buffer |
500 |
0.5, 1, 1.5, 2, 3, 4, 5 and 6 hours |
2017/11/02 |
| Deutetrabenazine |
Tablet, Extended Release |
II (Paddle) with sinker |
75 |
50 mM Potassium Biphthalate pH 3.0 |
500 |
1, 2, 4, 6, 8, 10, 12, 16 and 20 hours |
2025/06/23 |
| Deutivacaftor (Deu); Tezacaftor (Tez); Vanzacaftor Calcium (Van) |
Tablet |
II (Paddle) |
75 |
Van and Deu: 0.5% (w/v) SLS in 50 mM sodium phosphate, pH 6.8; Tez: 0.2% (w/v) SLS solution in 0.1 N HCl |
900 |
5, 10, 15, 20, 30, 45, 60 and 75 |
2026/01/28 |
| Dexamethasone |
Implant (Intravitreal) |
VII (with reciprocating 50 mesh baskets) |
30 cycles per min |
Phosphate Buffered Saline containing 0.05 g/L sodium dodecyl sulfate at 45 ± 0.5°C |
30 |
12, 24, 48, 72, 96, 120, 144, 168, 192, 216 and 240 hours |
2010/10/21 |
| Dexamethasone |
Tablet |
|
|
Refer to FDA's Dissolution Guidance, 2018 |
|
|
2020/07/02 |
| Dexamethasone/Neomycin Sulfate/ Polymyxin B Sulfate |
Ophthalmic Suspension |
|
|
Develop a method to characterize in vitro release |
|
|
2018/02/15 |
| Dexamethasone/Tobramycin |
Ophthalmic Suspension |
|
|
Develop a method to characterize in vitro release |
|
|
2009/04/02 |
| Dexbrompheniramine Maleate/Pseudoephedrine Sulfate |
Tablet (Extended Release) |
III (Reciprocating Cylinder) |
12 dpm |
0.02N HCl (2 hours) followed by
0.05M Phosphate Buffer pH 7.5 |
250 |
0.5, 1, 2, 3, 4, 6 and 8 hours |
2015/05/28 |
| Dexlansoprazole |
Capsule (Delayed Release) |
I (Basket) |
100 |
Acid Stage: 0.1 N HCl, Buffer Stage: pH 7.0 Phosphate Buffer with 5 mM SLS |
Acid Stage: 500; Buffer stage: 900 |
Acid Stage: 120; Buffer Stage: 10, 20, 40, 50, 60 , 75, 105 and 120 |
2010/08/05 |
| Dexlansoprazole |
Tablet (Delayed Release, Orally Disintegrating) |
I (Basket -100 mesh) |
100 |
Acid Stage: 0.1 N HCl; Buffer Stage: pH 7.2 Phosphate Buffer with 5 mM Sodium lauryl sulfate |
Acid Stage: 500 mL; Buffer Stage: 900 mL |
Acid Stage: 120; Buffer Stage: 10, 15, 20, 30, 50, 60, 75 and 90 |
2016/07/28 |
| Dexmedetomidine HCl |
Sublingual Film |
V (Paddle over disk) |
50 |
Simulated saliva |
500 |
5, 10, 15, 20 and 30 |
2023/05/31 |
| Dexmethylphenidate HCl |
Tablet |
|
|
Refer to FDA's Dissolution Guidance, 2018 |
|
|
2020/07/02 |
| Dexmethylphenidate HCl |
Capsule (Extended Release) |
I (Basket) |
100 |
First 2 hours: 0.01 N HCl, Hours 2-10: Phosphate Buffer, pH 6.8 |
Acid: 500, Buffer: 500 |
0.5, 1, 2, 4, 6, and 10 hours |
2008/01/14 |
| Dexmethylphenidate HCl; Serdexmethylphenidate Chloride |
Capsule |
|
|
Refer to FDA's Dissolution Guidance, 2018 |
|
|
2023/05/18 |
| Dextroamphetamine |
Transdermal System |
VI (Cylinder) |
50 |
50 mM potassium phosphate buffer, pH 6.8 |
|
5, 10, 15, 30, 45, 60, 120, 180, 240, 300 and 360 |
2023/11/30 |
| Dextroamphetamine Sulfate |
Tablet |
|
|
Develop a dissolution method |
|
|
2023/09/15 |
| Dextroamphetamine Sulfate |
Tablet |
|
|
Refer to FDA's Dissolution Guidance, 2018 |
|
|
2020/07/02 |
| Dextroamphetamine Sulfate |
Capsule (Extended Release) |
I ( Basket) |
100 |
0.1 N HCl |
500 |
1, 4, 8 and 12 hours |
2008/11/25 |
| Dextromethophan HBr/Guaifenesin |
Tablet (Extended Release) |
I (Basket) |
50 |
0.01 N HCl |
900 |
1, 2, 6, and 12 hours |
2008/11/25 |
| Dextromethorphan Hydrobromide/Quinidine Sulfate |
Capsule |
I (Basket) |
100 |
pH 1.2, Simulated Gastric Fluid without enzyme |
900 |
5, 10, 15, 20 and 30 |
2012/01/05 |