| Doxazosin Mesylate |
Tablet |
II (Paddle) |
50 |
0.01 N HCl |
900 |
10, 20, 30, 45 and 60 |
2004/01/27 |
| Doxazosin Mesylate |
Tablet (Extended Release) |
II (Paddle) |
75 |
SGF without enzyme |
900 |
1, 2, 4, 6, 8, 12 and 16 hours |
2007/01/03 |
| Doxepin HCl |
Tablet |
II (Paddle) |
50 |
Simulated Gastric Fluid w/o enzyme (pH 1.1-1.3) |
900 |
5, 10, 15, 20, 30 and 45 |
2010/09/02 |
| Doxepin HCl |
Capsule |
|
|
Refer to FDA's Dissolution Guidance, 2018 |
|
|
2020/07/02 |
| Doxepin HCl |
Tablet |
|
|
Refer to FDA's Dissolution Guidance, 2018 |
|
|
2020/07/02 |
| Doxercalciferol |
Capsule |
|
|
Develop a quantitative rupture test |
|
|
2008/06/03 |
| Doxorubicin HCl |
Injectable (Liposomal) |
|
|
Develop a method to characterize in vitro release, starting at pH 6.00 ± 0.05 and at 47ºC ± 0.5ºC. Replicate for 12 dosage vials. |
|
|
2012/10/04 |
| Doxycycline |
Capsule (Delayed Release) |
II (Paddle) |
75 |
Dilute HCl, pH 1.1 for 2 hours and then add 200 mL of 0.1 N NaOH in 200 mM Phosphate Buffer. Adjust pH to 6.0 using 2 N HCl and/or 2N NaOH |
Acid stage: 750; Buffer stage: 950 |
1, 2, 2.5 , 3 and 4 hours |
2008/10/06 |
| Doxycycline |
Suspension |
II (Paddle) |
25 |
0.01 N HCl |
900 |
5, 10, 15 and 20 |
2008/09/03 |
| Doxycycline Calcium |
Suspension |
|
|
Develop a dissolution method |
|
|
2019/03/07 |
| Doxycycline Hyclate |
Capsule |
|
|
Refer to FDA's Dissolution Guidance, 2018 |
|
|
2020/07/02 |
| Doxycycline Hyclate |
Tablet |
|
|
Refer to FDA's Dissolution Guidance, 2018 |
|
|
2020/07/02 |
| Doxycycline Hyclate ( 120 mg and 60 mg) |
Tablet (Delayed Release) |
I (Basket) |
100 |
Acid stage: 0.06 N HCl; Buffer stage: Neutralized Phthalate Buffer, pH 5.5 |
Acid stage: 900 mL; Buffer stage: 900 mL |
Acid stage: 10, 20, 30, 45 and 60; Buffer stage: 5, 10, 15, 20, 30 and 45 |
2018/03/27 |
| Doxycycline Hyclate ( 150 mg and 75 mg) |
Tablet |
|
|
Refer to FDA's Dissolution Guidance, 2018 |
|
|
2020/07/02 |
| Doxycycline Hyclate ( 200 mg, 150 mg, 100 mg, 80 mg and 75 mg) |
Tablet (Delayed Release) |
|
|
Refer to USP |
|
|
2015/05/28 |
| Doxycycline Hyclate ( 50 mg) |
Tablet (Delayed Release) |
I (Basket) |
100 |
Acid stage: 0.06 N HCl; Buffer stage: Neutralized Phthalate Buffer, pH 5.5 |
900 |
Acid stage: 5, 10, 15, 20 and 30; Buffer stage: 5, 10, 15, 20 and 30 |
2015/05/28 |
| Doxylamine Succinate/Pyridoxine HCl |
Tablet (Extended Release) |
II (Paddle) |
100 |
Acid stage: 0.1 N HCl: Buffer stage: 0.2M sodium phosphate buffer pH 6.8 |
Acid stage: 1000 mL; Buffer stage: 1000 mL |
Acid stage: 5, 10, 15, 30, 60, 120; Buffer stage: 5, 10, 15, 20 and 30 |
2017/01/19 |
| Dronabinol |
Capsule |
|
|
Develop a dissolution method; (In addition, the USP capsule rupture test should also be conducted) |
|
|
2023/09/15 |
| Dronedarone HCl |
Tablet |
II (Paddle) with sinker |
75 |
pH 4.5 Phosphate buffer |
1000 |
10, 15, 20, 30, 45, 60, 90 and 120 |
2015/02/25 |
| Drospirenone/Estetrol |
Tablet |
II (Paddle) |
50 |
Phosphate Buffer pH 6.8 |
900 |
5,10, 15, 20 and 30 |
2023/03/30 |