| Mesalamine (1.2 gram) |
Tablet (Delayed Release) |
II (Paddle) |
100 |
Acid stage (A): 100 mM HCl Buffer stage (B): Phosphate Buffer, pH 6.4 Buffer stage (C): Phosphate Buffer, pH 7.2 |
Acid stage (A): 750 mL; Buffer stage (B): 950 mL; Buffer stage (C): 960 mL |
Acid stage (A): 2 hours; Buffer stage (B): 1 hour; Buffer stage (C): 1, 2, 4, 6 and 8 hours |
2009/06/10 |
| Mesalamine (250 mg and 500 mg) |
Capsule (Extended Release) |
|
|
Refer to USP |
|
|
2009/06/10 |
| Mesalamine (375 mg) |
Capsule (Extended Release) |
I (Basket) |
100 |
Acid Stage: 0.1N HCl Buffer stage: Phosphate Buffer, pH 6.8 |
Acid stage: 750 mL; Buffer stage: 1000 mL |
Acid stage: 2 hours; Buffer stage: 0.5, 1, 2, 4, 7 and 9 hours |
2009/06/10 |
| Mesalamine (400 mg and 800 mg) |
Tablet (Delayed Release) |
|
|
Refer to USP |
|
|
2010/11/05 |
| Mesalamine Enema |
Rectal Enema |
II (Paddle) |
50 |
Phosphate Buffer, pH 7.2 |
900 |
5, 10, 15, and 30 |
2007/06/18 |
| Mesna |
Tablet |
II (Paddle) |
50 |
0.06 N HCl |
500 |
5, 10, 15, 20 and 30 |
2004/02/09 |
| Mestranol/Norethindrone |
Tablet |
|
|
Refer to USP |
|
|
2010/03/25 |
| Metaxalone |
Tablet |
|
|
Develop a dissolution method |
|
|
2024/01/03 |
| Metformin HCl |
Tablet |
|
|
Refer to FDA's Dissolution Guidance, 2018 |
|
|
2020/07/02 |
| Metformin HCl |
For Suspension (Extended Release) |
II (Paddle) |
100 |
Phosphate Buffer, pH 6.8 |
1000 |
0.5, 1, 2, 3, 4, 6, 8, 10 and 12 hours |
2020/01/30 |
| Metformin HCl |
Tablet (Extended Release) |
|
|
Refer to USP |
|
|
2008/12/12 |
| Metformin HCl (MET); Sitagliptin (SIT) |
Tablet (Extended Release) |
II (Paddle) with sinker |
75 |
Phosphate buffer, pH 6.8 |
900 |
MET: 1, 2, 3, 4, 6, 8, 10, and 12 hours; SIT: 10, 20, 30, 45 and 60 |
2023/07/07 |
| Metformin HCl/Pioglitazone HCl |
Tablet |
II (Paddle) |
50 |
pH 2.5 McIlvaine buffer (0.1 M Citric acid adjusted to pH 2.5 with 0.2 M Na2HPO4) |
900 |
10, 20, 30 and 45 |
2007/01/03 |
| Metformin HCl/Saxagliptin |
Tablet (Extended Release) |
I (Basket) |
100 |
Phosphate Buffer, pH 6.8 |
1000 |
Metformin: 1, 2, 3, 4, 6, 8, 10 and 12 hours. Saxagliptin: 5, 10, 15, 20 and 30 minutes |
2012/01/26 |
| Metformin HCl/Sitagliptin Phosphate |
Tablet |
II (Paddle) |
75 |
0.025 M NaCl |
900 |
10, 15, 20 and 30 |
2008/10/06 |
| Metformin/Repaglinide |
Tablet |
II (Paddle) |
50 |
Citric acid/phosphate buffer, pH 5.0 |
900 |
5, 10, 15, 20 and 30 |
2009/10/30 |
| Methadone HCl |
Tablet |
|
|
Refer to FDA's Dissolution Guidance, 2018 |
|
|
2020/07/02 |
| Methazolamide |
Tablet |
II (Paddle) |
100 |
pH 4.5 Acetate Buffer |
900 |
10, 15, 20, 30 and 45 |
2015/05/28 |
| Methenamine Hippurate |
Tablet |
|
|
Refer to FDA's Dissolution Guidance, 2018 |
|
|
2020/07/02 |
| Methimazole |
Tablet |
|
|
Refer to USP |
|
|
2008/01/14 |