| Itraconazole |
Capsule |
II (Paddle) |
100 |
SGF without Enzyme |
900 |
10, 20, 30, 45, 60 and 90 |
2004/02/04 |
| Itraconazole |
Tablet |
II (Paddle) |
75 |
0.1 N HCl |
900 |
5, 15, 30, 45, 60, 75 and 90 |
2013/08/15 |
| Ivabradine HCl |
Tablet |
|
|
Refer to FDA's Dissolution Guidance, 2018 |
|
|
2020/07/02 |
| Ivacaftor |
Tablet |
II (Paddle) with sinker |
65 |
50 mM Sodium Phosphate Buffer with 0.7% Sodium Dodecyl Sulfate (SDS), pH 6.8 |
900 |
5, 10, 15, 20 and 30 |
2015/06/25 |
| Ivacaftor/lumacaftor |
Tablet |
Lumacaftor: II (Paddle); Ivacaftor: II (Paddle) |
Lumacaftor:65; Ivacaftor: 65 |
Lumacaftor: 0.5% (w/v) CTAB in 50 mM Sodium Acetate Trihydrate buffer (pH 4.5); Ivacaftor: 0.4% (w/v) SLS in 50 mM Sodium Phosphate buffer (pH 6.8) |
Lumacaftor: 900; Ivacaftor: 900 |
5, 10, 15, 20 and 30 |
2016/03/17 |
| Ivacaftor/Tezacaftor [FDC: IVA+ TEZ]; Ivacaftor [IVA] |
Tablet/Tablet (Copackage) |
II (Paddle) with option to use a sinker |
FDC: IVA: 65/TEZ:75; IVA: 65 |
FDC: IVA: 50 mM Sodium Phosphate Buffer with 0.4% Sodium Dodecyl Sulfate (SDS), pH 6.8/TEZ: 0.2 SDS% in 0.1 N HCl; IVA: 50 mM Sodium Phosphate Buffer with 0.7% SDS, pH 6.8; |
FDC: IVA: 900/ TEZ: 900; IVA: 900 |
5, 10, 15, 20, 30 and 45 |
2019/03/07 |
| Ivermectin |
Tablet |
II (Paddle) |
50 |
0.5% SDS in 0.01 M Monobasic Sodium Phosphate, pH 7.0 |
900 |
10, 20, 30, 45 and 60 |
2004/02/04 |
| Ivosidenib |
Tablet |
II (Paddle) |
50 |
50 mM Phosphate Buffer pH, 6.8 with 0.6% sodium dodecyl sulfate (SDS), |
900 |
10, 15, 20, 30 and 45 |
2020/08/27 |
| Ixazomib Citrate |
Capsule |
I (Basket) |
100 |
0.1 N HCl |
500 |
5, 10, 15, 20 and 30 |
2016/10/20 |
| Ketoconazole |
Tablet |
I (Basket) |
100 |
Simulated gastric fluid w/o pepsin |
800 |
15, 30, 45, 60 and 90 |
2007/01/03 |
| Ketoprofen |
Capsule |
II (Paddle with sinker) |
50 |
0.05M Potassium Phosphate Buffer, pH 7.4 |
1000 |
10, 20, and 30 |
2023/02/09 |
| Ketoprofen |
Tablet |
II (Paddle) |
50 |
SIF Buffer without enzyme, pH 7.4 |
900 |
10, 20, 30, 45 and 60 |
2004/02/05 |
| Ketorolac Tromethamine |
Tablet |
|
|
Refer to FDA's Dissolution Guidance, 2018 |
|
|
2020/07/02 |
| Labetalol HCl |
Tablet |
|
|
Refer to FDA's Dissolution Guidance, 2018 |
|
|
2020/07/02 |
| Lacosamide |
Tablet |
|
|
Refer to FDA's Dissolution Guidance, 2018 |
|
|
2020/07/02 |
| Lacosamide |
Capsule (Extended Release) |
I (Basket) |
100 |
Phosphate Buffer, pH 6.8 |
900 |
0.5, 1, 2, 3, 4, 5, 6, 8, 10 and 12 hours |
2024/05/31 |
| Lamivudine |
Tablet |
|
|
Refer to FDA's Dissolution Guidance, 2018 |
|
|
2020/07/02 |
| Lamivudine 150 mg/Zidovudine 300mg Tablets and Abacavir Sulfate 300 mg Tablets-co-packaged |
Tablet |
II (Paddle) |
75 |
0.1 N HCl |
900 |
5, 10, 15, 20, 30 and 40 |
2007/01/03 |
| Lamivudine/Raltegravir Ka |
Tablet |
|
|
Develop a dissolution method |
|
|
2023/09/15 |
| Lamivudine/Stavudine/Nevirapine |
Tablet |
II (Paddle) |
75 |
0.1 N HCl |
900 |
10, 20, 30, 45 and 60 |
2007/01/03 |