| Oxycodone HCl |
Tablet |
|
|
Refer to FDA's Dissolution Guidance, 2018 |
|
|
2020/07/02 |
| Oxycodone HCl |
Tablet (Extended Release) |
|
|
Refer to USP |
|
|
2016/03/17 |
| Oxycodone HCl/ Naloxone HCl |
Tablet (Extended Release) |
II (Paddle) |
50 |
Simulated Gastric Fluid [SGF, pH 1.2] without enzyme |
900 |
0.25, 0.5, 1, 2, 4, 6, 8, 10 and 12 hours |
2016/12/22 |
| Oxymorphone HCl |
Tablets |
|
|
Refer to FDA's Dissolution Guidance, 2018 |
|
|
2020/07/02 |
| Oxymorphone HCl |
Tablet (Extended Release) |
II (Paddle) with sinker |
50 |
45 mM Phosphate Buffer, pH 4.5 |
900 |
1, 2, 4, 6, 8 and 10 hours |
2014/02/14 |
| Ozanimod HCl |
Capsule |
|
|
Refer to FDA's Dissolution Guidance, 2018 |
|
|
2022/05/12 |
| Pacritinib Citrate |
Capsule |
II (Paddle) with sinker |
75 |
0.08 M HCl/0.034 M NaCl, pH 1.2 |
900 |
5, 10, 15 and 30 |
2023/05/18 |
| Palbociclib |
Tablet |
II (Paddle) |
75 |
0.1 N HCl |
900 |
10, 15, 20, 30 and 45 |
2021/08/19 |
| Palbociclib |
Capsule |
II (Paddle) with sinker |
50 |
0.1 N HCl |
900 |
10, 15, 20, 30 and 45 |
2016/03/17 |
| Paliperidone |
Tablet (Extended Release) |
II (Paddle) |
50 |
Modified SGF, pH 1.0 [NaCl (0.2% w/w) in 0.0825N HCl] |
500 |
1, 2, 4, 6, 8, 12, 14, 18 and 24 hours |
2009/08/27 |
| Paliperidone Palmitate |
Intramuscular Suspension (Extended Release) |
|
|
Develop a method to characterize in vitro release |
|
|
2026/03/25 |
| Palonosetron HCl |
Capsule |
|
|
Refer to FDA's Dissolution Guidance, 2018 |
|
|
2020/07/02 |
| Palovarotene |
Capsule |
II (Paddle) with sinkers |
50 |
5 mM Phosphate buffer, pH 8.0 with 0.5% SLS |
900 |
5, 10, 15, 30, 45 and 60 |
2024/11/01 |
| Pancrelipase |
Capsule (Delayed Release) |
|
|
Refer to USP |
|
|
2016/03/17 |
| Pancrelipase |
Tablet |
II (Paddle) |
50 |
Phosphate Buffer, pH 4.5 |
900 |
10, 20, 30, 45 and 60 |
2016/06/02 |
| Panobinostat Lactate |
Capsule |
|
|
Refer to FDA's Dissolution Guidance, 2018 |
|
|
2020/07/02 |
| Pantoprazole Sodium |
Delayed Release Granules for Oral Suspension |
II (Paddle) |
100 |
Acid Stage: 0.1 N Hydrochloric Acid; Buffer Stage: 0.05 M Tribasic Sodium Phosphate (Add 250 mL of 0.2 mM Tribasic Sodium Phosphate after completion of acid stage); pH 6.8 (Method B) |
Acid stage: 750; Buffer stage: 1000 |
Acid stage: 60, 90 and 120; Buffer stage: 10, 20, 30, 45 and 60 |
2009/10/30 |
| Pantoprazole Sodium |
Tablet (Delayed Release) |
|
|
Refer to USP |
|
|
2009/07/21 |
| Paricalcitol |
Capsule |
I (Basket) |
100 |
4 mg/mL (0.4%) Lauryldimethylamine N-oxide (LDAO) |
500 |
20, 30, 45, 60 |
2007/06/18 |
| Paromomycin Sulfate |
Capsule |
|
|
Refer to FDA's Dissolution Guidance, 2018 |
|
|
2020/07/02 |