| Colesevelam HCl |
Tablet |
|
|
Disintegration Testing as per USP <701> in various media such as simulated gastric fluid and simulated intestinal fluid. |
|
|
2010/10/28 |
| Crizotinib |
Capsule |
I (Basket) |
100 |
0.1N HCl (degassed) |
900 |
5, 10, 15, 30 and 45 |
2016/04/14 |
| Crofelemer |
Tablet (Delayed Release) |
II (Paddle) |
75 |
Acid stage: 0.1 N HCl; Buffer stage: Sodium phosphate buffer, pH 6.8 |
Acid stage: 750; Buffer stage: 1000 |
Acid stage: 2 hours; Buffer stage: : 5, 10, 20, 30 and 45 minutes |
2016/06/02 |
| Cyclobenzaprine |
Capsule (Extended Release) |
|
|
Refer to USP |
|
|
2016/10/20 |
| Cyclobenzaprine HCl |
Tablet |
|
|
Refer to USP |
|
|
2007/07/25 |
| Cyclophosphamide |
Tablet |
|
|
Develop a dissolution method |
|
|
2023/09/15 |
| Cycloserine |
Capsule |
|
|
Develop a dissolution method |
|
|
2024/01/03 |
| Cyclosporine (100 mg) (AB1) |
Capsule (Liquid filled) |
II (Paddle) |
75 |
0.1 N HCl containing 4 mg of N,N-dimethydodecylamine-N-oxide per mL |
1000 |
10, 20, 30, 45, 60 and 90 |
2008/01/14 |
| Cyproheptadine HCl |
Tablet |
|
|
Refer to FDA's Dissolution Guidance, 2018 |
|
|
2020/07/02 |
| Cysteamine Bitartrate |
Granule (Delayed Release) |
I (Basket |
75 rpm (for 75 mg strength); 150 rpm (for 300 mg strength) |
Acid Stage: 0.1 N HCl; Buffer Stage: 0.2M Sodium Phosphate buffer, pH 6.8 |
Acid Stage: 1000; Buffer Stage:1000 |
Acid Stage: 120; Buffer Stage: 5, 10, 15, 20 and 30 |
2020/08/27 |
| Cysteamine Bitartrate |
Capsule (Delayed Release) |
I (Basket) |
75 |
Acid stage: 0.1N HCl;
Buffer stage: 0.05 M Sodium Phosphate buffer, pH 6.8 |
Acid stage: 1000; Buffer stage: 1000 |
Acid stage: 2 hours; Buffer stage: : 5, 10, 15, 20 and 30 minutes |
2015/08/27 |
| Cysteamine Bitartrate |
Capsule |
I (Basket) |
75 |
0.1 N HCl |
900 |
10, 20, 30 and 45 |
2004/01/24 |
| Dabigatran Etexilate Mesylate |
Capsule |
I (Basket) for 75 strength: I (Basket with modified diameter of 24.5 mm) for 150 mg strength: |
100 |
0.01 N HCl (pH 2.0) |
900 |
10, 20, 30, and 45 |
2011/09/22 |
| Dabrafenib Mesylate |
Capsule |
II (Paddle) |
65 |
0.2% Cetyl trimethylammonium bromide (CTAB) in 0.1N HCl |
900 |
10, 15, 20, 30 and 45 |
2015/05/28 |
| Daclatasvir Dihydrochloride |
Tablet |
II (Paddle) |
75 |
Phosphate Buffer, pH 6.8 with 0.75% Brij 35 |
1000 |
10, 15, 20, 30 and 45 |
2016/03/17 |
| Dalfampridine |
Tablet (Extended Release) |
II (Paddle) |
50 |
Phosphate Buffer, pH 6.8 |
900 |
0.5, 1, 2, 4, 6, 8, 10 and 12 hours |
2012/06/07 |
| Danazol |
Capsule |
|
|
Refer to USP |
|
|
2007/06/18 |
| Dantrolene Sodium |
For suspension (Intravenous ) |
II (Paddle) |
50 |
0.5% Benzalkonium Chloride in water |
900 |
0.5, 1, 2, 3, 5 and 10 |
2017/03/02 |
| Dantrolene Sodium |
Capsule |
I (Basket) |
100 |
0.5% Hyamine 10X in water, adjust to pH 6.8 with 0.1 N KOH or 0.1 N HCl |
900 |
10, 20, 30, 40 and 60 |
2004/01/27 |
| Dapagliflozin Propanediol |
Tablet |
|
|
Refer to FDA's Dissolution Guidance, 2018 |
|
|
2020/07/02 |