| Olanzapine; Samidorphan L-malate |
Tablet |
|
|
Refer to FDA's Dissolution Guidance, 2018 |
|
|
2023/05/18 |
| Olaparib |
Tablet |
I (Basket) |
100 |
50 mM Phosphate Buffer, pH 6.8 |
900 |
15, 30, 45 and 60 |
2024/02/16 |
| Olmesartan Medoxomil |
Tablet |
|
|
Refer to USP |
|
|
2017/11/02 |
| Olsalazine Sodium |
Capsule |
I (Basket) |
100 |
Phosphate Buffer, pH 7.5 |
900 |
10, 20, 30 and 45 |
2004/02/12 |
| Olutasidenib |
Capsule |
II (Paddle) with sinkers |
65 |
McIlvaine Buffer, pH 2.2 W/ 1.25% SDS |
500 |
10, 15, 30, 45, and 60 |
2024/02/05 |
| Omaveloxolone |
Capsule |
I (Basket) |
100 |
50 mM Sodium Phosphate Buffer, pH 6.8 |
900 |
10, 15, 20, 30, 45 and 60 |
2024/05/31 |
| Ombitasvir/ Paritaprevir/ Ritonavir and Dasabuvir Sodium |
Tablet |
II (Paddle) |
75 |
Ombitasvir, paritaprevir, ritonavir: 0.05 M sodium phosphate buffer, pH 6.8 with 0.3% polyoxyethylene 10 lauryl ether; Dasabuvir sodium: 0.05 M Sodium Phosphate buffer, pH 6.8 with 15 mM cetyl triethylammonium bromide (CTAB) |
900 |
Ombitasvir, paritaprevir, ritonavir: 10, 20, 30, 45, 60, 90, 120 and 150; Dasabuvir: 5, 10, 15, 20 and 30 |
2015/08/27 |
| Ombitasvir/Paritaprevir/Ritonavir |
Tablet |
II (Paddle) with sinker |
75 |
0.05M Sodium Phosphate Buffer, pH 6.8 with 0.3% (w/v) Polyoxyethylene 10 Lauryl Ether (POE10LE) |
900 |
10, 20, 30, 45, 60, 90, 120, 150 and 180 |
2016/06/30 |
| Omega-3-Acid Ethyl Esters Type A |
Capsule |
|
|
Develop an in vitro release method using USP IV (Flow-Through Cell), and, if applicable, Apparatus II (Paddle) or any other appropriate pharmacopoeial apparatus, for comparative evaluation by the Agency. |
|
|
2025/09/08 |
| Omeprazole |
OTC Tablet (Delayed Release) |
II (Paddle) |
100 |
Tablets are pre-exposed to 750 ml of 0.1M HCL for 2 hrs and then 250 ml of 0.2M Na3PO4 is added to the medium to give 1000 ml with pH 6.8 |
Acid stage: 750; Buffer stage: 1000 |
Acid stage: 120; Buffer stage: 10, 20, 30, 45 and 60 |
2013/02/28 |
| Omeprazole |
Capsule (Delayed Release) |
|
|
Refer to USP |
|
|
2007/06/18 |
| Omeprazole (Orally Disintegrating) |
OTC Tablet (Delayed Release) |
II (Paddle) |
100 |
Tablets are pre-exposed to 500 ml of 0.1M HCL for 2 hrs and then 400 ml of 0.235M Na2HP04 is added to the medium. Adjust if necessary with 2 N HCI or 2 N NaOH to a pH of 6.8 |
Acid stage: 500; Buffer stage: 900 |
Acid stage: 120; Buffer stage: 10, 20, 30, 45 and 60 |
2018/02/08 |
| Omeprazole Magnesium |
Capsule, Delayed Release |
II (Paddle) |
100 |
Acid stage: 0.1 N HCl (deaerated) for 2 hrs; Buffer stage: Phosphate buffer (deaerated), pH 6.8 |
|
Acid stage: 120; Buffer stage: 10, 20, 30 and 45 |
2023/03/30 |
| Omeprazole Magnesium |
For suspension (Delayed Release) |
II (Paddle) |
100 |
Pre-exposed to 300 mL of 0.1M HCl for 2 hrs and then 700 mL of 0.086 M Na2HPO4 is added to the medium to give 1000 mL with pH 6.8 |
Acid stage: 300; Buffer stage: 1000 |
Acid stage: 120; Buffer stage: 10, 20, 30, 45 and 60 |
2019/02/07 |
| Omeprazole Magnesium |
OTC Tablet (Delayed Release) |
II (Paddle) |
100 |
Tablets are pre-exposed to 300 mL of 0.1M HCL for 2 hrs and then 700 mL of 0.086 M Na2HPO4 is added to the medium containing the capsule to give 1000 mL with pH 6.8 |
300 ml for the acid stage; 1000 ml for the buffer stage |
Sampling started at the buffer stage 10, 20, 30, 45 and 60 |
2007/01/03 |
| Omeprazole Sodium Bicarbonate |
Capsule |
II (Paddle) |
75 |
Phosphate Buffer, pH 7.4 |
900 |
15, 30, 45 and 60 |
2008/07/14 |
| Omeprazole; Sodium Bicarbonate (2 mg/mL; 84 mg/mL) |
For Suspension |
II (Paddle) |
25 |
Sodium Phosphate buffer, pH 7.4 |
900 |
5, 10, 15, 20, 30, 45 and 60 |
2026/01/28 |
| Omeprazole; Sodium Bicarbonate (20 mg;1.68 g and 40 mg;1.68 g) |
For Suspension |
II (Paddle) |
50 |
Sodium Phosphate Buffer, pH 7.4 |
900 |
5, 10, 15, 20, 30, 45 and 60 |
2026/01/28 |
| Ondansetron |
Film (Oral) |
V (Paddle over Disk) with a stainless steel disk (120 mesh screens) |
50 |
0.1 N HCl |
900 |
5, 10, 15, 20 and 30 |
2012/01/26 |
| Ondansetron |
Tablet (Orally Disintegrating) |
|
|
Refer to USP |
|
|
2007/06/18 |