| Pitavastatin Calcium |
Tablet |
I (Basket) |
35 |
0.05 M Phosphate Buffer, pH 6.8 |
900 |
5, 10, 15, 20, 30 and 45 |
2010/12/23 |
| Pomalidomide |
Capsule |
II (Paddle) |
50 |
0.1 N HCl |
900 |
10, 15, 20, 30 and 45 |
2015/05/28 |
| Ponatinib HCl |
Tablet |
I (Basket) |
50 |
pH 2.1, KCl/HCl buffer (degassed) |
900 |
10, 15, 20, 30, 45 and 60 |
2015/09/03 |
| Posaconazole |
For Suspension (Delayed Release) |
II (Paddle) |
75 |
Acid stage: 0.01 N HCl; Buffer stage: pH 6.8 Phosphate buffer with 1.3% Tween 80; |
Acid stage: 750 mL; Buffer stage: 1000 mL |
Acid stage: 120; Buffer stage: 5, 10, 15, 20, 30 and 45 |
2022/07/07 |
| Posaconazole |
Tablet (Delayed Release) |
II (Paddle) |
75 |
Acid Stage: 0.01 N HCl: Buffer Stage: 50 mM phosphate buffer, pH 6.8 with 0.37 % Polysorbate 80 (after 120 minutes, to the acid stage, add 250 mL of 0.2M Phosphate Buffer, 1.46% Polysorbate 80) |
Acid Stage: 750 mL; Buffer Stage 1000 mL |
Acid Stage: 120; Buffer Stage: 10, 15, 20, 30 and 45 |
2015/06/25 |
| Posaconazole |
Oral Suspension |
II (Paddle) |
25 |
0.3% SLS |
900 |
10, 20, 30 and 45 |
2007/12/03 |
| Potassium Chloride |
Tablet (Extended Release) |
|
|
Develop a dissolution method |
|
|
2024/01/03 |
| Potassium Chloride |
Capsule (Extended Release) |
|
|
Develop a dissolution method |
|
|
2024/01/03 |
| Potassium chloride |
For suspension, Extended Release |
|
|
Develop a dissolution method |
|
|
2026/01/28 |
| Potassium Citrate |
Tablet |
|
|
Develop a dissolution method |
|
|
2024/01/03 |
| Pralsetinib |
Capsule |
II (Paddle) with sinker |
50 |
50 mM Sodium Phosphate Buffer, pH 6.8, with 0.4% w/v Cetyl Trimethylammonium Bromide (CTAB) |
900 |
10, 20, 30, 45 and 60 |
2022/07/07 |
| Pramipexole Dihydrochloride |
Tablet |
|
|
Refer to FDA's Dissolution Guidance, 2018 |
|
|
2020/07/02 |
| Pramipexole Dihydrochloride |
Tablet (Extended Release) |
I (Basket) |
100 |
0.05 M phosphate buffer, pH 6.8 |
500 |
1, 2, 4, 6, 9, 12, 16, 20 and 24 hours |
2010/09/02 |
| Prasugrel HCl |
Tablet |
II (Paddle) |
75 |
Citrate-Phosphate buffer (0.023M Citric acid+0.026M Sodium Phosphate, Dibasic), pH 4.0 |
900 |
10, 15, 20, 30 and 45 |
2012/10/04 |
| Pravastatin Sodium |
Tablet |
|
|
Refer to FDA's Dissolution Guidance, 2018 |
|
|
2020/07/02 |
| Praziquantel |
Tablet |
|
|
Refer to USP |
|
|
2015/06/25 |
| Prazosin HCl |
Capsule |
|
|
Refer to USP |
|
|
2022/05/12 |
| Prednisolone |
Tablet |
|
|
Develop a dissolution method |
|
|
2024/01/03 |
| Prednisolone Acetate |
Ophthalmic Suspension |
|
|
Develop an in vitro release method |
|
|
2014/05/15 |
| Prednisolone Sodium Phosphate |
Tablet (Orally Disintegrating) |
II (Paddle) |
50 |
22 mM Sodium Acetate Buffer, pH 4.5 |
500 |
5, 15, 30, 45 and 60 |
2008/09/03 |