| Molindone HCl |
Tablet |
|
|
Refer to FDA's Dissolution Guidance, 2018 |
|
|
2020/07/02 |
| Momelotinib |
Tablet |
II (Paddle) |
75 |
22 mM Sodium Acetate Buffer, pH 4.5 w/1.3% SDS |
900 |
10, 15, 20, 30 and 45 |
2025/02/24 |
| Monomethyl Fumarate |
Capsule (Delayed Release) |
II (Paddle) Stationary Basket over the Paddle |
100 |
Acid Stage: 0.1 N HCl; Buffer Stage: Phosphate buffer, pH 6.8 |
|
Acid Stage: 120; Buffer Stage: 15, 30, 45, 60, 90, 120 and 150 |
2020/08/27 |
| Montelukast |
Granule |
|
|
Develop a dissolution method |
|
|
2023/09/15 |
| Montelukast Sodium |
Tablet (Chewable) |
|
|
Develop a dissolution method |
|
|
2023/09/15 |
| Montelukast Sodium |
Tablet |
|
|
Develop a dissolution method |
|
|
2023/09/15 |
| Morphine Sulfate |
Tablet |
|
|
Refer to FDA's Dissolution Guidance, 2018 |
|
|
2020/07/02 |
| Morphine Sulfate |
Tablet (Extended Release) |
I (Basket) |
100 |
Simulated Gastric Fluid [SGF] without enzyme |
900 |
0.25, 0.5, 1, 1.5, 2, 4, 6 and 8 hours |
2016/10/20 |
| Morphine Sulfate |
Capsule (Extended Release) |
|
|
Refer to USP |
|
|
2008/08/11 |
| Morphine Sulfate/Naltrexone HCl |
Capsule (Extended Release) |
II (Paddle) |
50 |
Acid stage: 0.1 N HCl; Buffer stage: 0.05 Phosphate Buffer, pH 7.5 |
Acid stage: 500; Buffer stage: 500 |
Morphine Sulfate: Acid stage: 1 hour; Buffer stage: 1, 3, 5, 8 and 10 hours. Naltrexone HCl: Acid stage: 1 hour; Buffer stage: 1, 12, 24, 48, 73 and 96 hours. |
2012/01/26 |
| Moxifloxacin |
Tablet |
|
|
Refer to FDA's Dissolution Guidance, 2018 |
|
|
2020/07/02 |
| Mycophenolate Mofetil |
Suspension |
II (Paddle) |
40 |
0.1 N HCl |
900 |
5, 10, 20 and 30 |
2004/02/10 |
| Mycophenolate Mofetil |
Capsule |
II (Paddle) |
40 |
0.1 N HCl |
900 |
5, 10, 20 and 30 |
2004/02/10 |
| Mycophenolate Mofetil |
Tablet |
II (Paddle) |
50 |
0.1 N HCl |
900 |
5, 10, 15 and 30 |
2004/02/10 |
| Mycophenolic acid |
Tablet (Delayed Release) |
II (Paddle) |
50 |
Acid Stage: 0.1 N HCl; Buffer Stage: Buffer Solution, pH 6.8 (After initial 120 mins., 250 mL of 0.2 M sodium phosphate solution is added to acid stage medium. The pH of the mixture is adjusted to 6.8 using 0.2 M sodium phosphate, 2 N sodium hydroxide, or concentrated HCl acid solution if necessary.) |
750 (Acid), 1000 (Buffer) |
120 (Acid), 10, 20, 30, 45 and 60 (Buffer) |
2008/12/19 |
| Nabilone |
Capsule |
II (Paddle) |
50 |
0.1% Tween 80 solution |
1000 |
15, 30, 45 and 60 |
2008/07/14 |
| Nabumetone |
Tablet |
|
|
Develop a dissolution method |
|
|
2024/01/03 |
| Nadolol |
Tablet |
|
|
Refer to FDA's Dissolution Guidance, 2018 |
|
|
2020/07/02 |
| Naldemedine |
Tablet |
|
|
Refer to FDA's Dissolution Guidance, 2018 |
|
|
2020/07/02 |
| Naloxegol Oxalate |
Tablet |
|
|
Refer to FDA's Dissolution Guidance, 2018 |
|
|
2020/07/02 |