| Risperidone |
Injectable |
|
|
Develop a dissolution method using USP IV (Flow-Through Cell), and, if applicable, Apparatus II (Paddle) or any other appropriate method, for comparative evaluation by the Agency |
|
|
2010/01/15 |
| Risperidone |
Tablet |
II (Paddle) |
50 |
0.1 N HCl |
500 |
10, 20, 30, 45 and 60 |
2006/03/04 |
| Risperidone |
Tablet (Orally Disintegrating) |
II (Paddle) |
50 |
0.1 N HCl |
500 |
5, 10, 15 |
2004/07/23 |
| Risperidone |
For Suspension (Extended Release) |
IV (Flow thru cell-closed loop) |
|
50 mM Potassium Phosphate Buffer, pH 7.4 |
1000 |
8, 24, 96, 120, 144, 168, 192, 216 and 264 hours |
2025/06/23 |
| Ritlecitinib Tosylate |
Capsule |
|
|
Refer to FDA's Dissolution Guidance, 2018 |
|
|
2024/11/01 |
| Ritonavir |
Powder |
I (Basket -100 mesh) |
100 |
0.1 N HCl |
900 |
5, 10, 15, 20 and 30 |
2017/11/16 |
| Ritonavir |
Tablet |
|
|
Develop a dissolution method |
|
|
2025/09/08 |
| Ritonavir |
Capsule |
|
|
Refer to USP |
|
|
2015/01/15 |
| Rivaroxaban (10 mg) |
Tablet |
II (Paddle) |
75 |
Acetate Buffer pH 4.5, 0.2% sodium dodecyl sulfate (SDS) |
900 |
10, 15, 20, 30 and 45 |
2015/01/15 |
| Rivaroxaban (15 and 20 mg) |
Tablet |
II (Paddle) |
75 |
Acetate Buffer pH 4.5, 0.4% SDS |
900 |
10, 15, 20, 30 and 45 |
2015/01/15 |
| Rivaroxaban (2.5 mg) |
Tablet |
II (Paddle) |
75 |
Acetate Buffer pH 4.5 |
900 |
10, 15, 20, 30 and 45 |
2019/02/07 |
| Rivastigmine |
Film, Transdermal |
Modified USP Type VI (cylinder) |
50 |
0. 9 % NaCl at 32º C |
500 |
1, 2, 4, 7, 9 and 12 hours |
2009/06/10 |
| Rivastigmine Tartrate |
Capsule |
|
|
Refer to FDA's Dissolution Guidance, 2018 |
|
|
2020/07/02 |
| Rizatriptan Benzoate |
Tablet |
|
|
Refer to FDA's Dissolution Guidance, 2018 |
|
|
2020/07/02 |
| Rizatriptan Benzoate |
Tablet, (Orally Disintegrating (ODT)) |
|
|
Develop a dissolution method |
|
|
2024/01/03 |
| Roflumilast |
Tablet |
II (Paddle) |
50 |
1.0% SDS (sodium dodecyl sulfate) in Phosphate Buffer, pH 6.8 |
1000 |
5, 10, 15, 20, 30 and 45 |
2013/08/15 |
| Rolapitant HCl |
Tablet |
II (Paddle) |
50 |
0.05 M Sodium Acetate buffer, pH 4.0 |
900 |
10, 15, 20, 30 and 45 |
2016/10/20 |
| Ropinirole HCl |
Tablet |
|
|
Refer to USP |
|
|
2014/05/15 |
| Ropinirole HCl |
Tablet (Extended Release) |
II (Paddle) |
100 |
pH 4.0 Citrate-THAM Buffer |
500 |
1, 2, 4, 6, 8, 12, 16, 20 and 24 hours |
2009/08/27 |
| Rosuvastatin Calcium |
Tablet |
|
|
Refer to FDA's Dissolution Guidance, 2018 |
|
|
2020/07/02 |
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