| Drospirenone/Estradiol |
Tablet |
|
|
Develop a dissolution method |
|
|
2023/09/15 |
| Drospirenone/Ethinyl Estradiol |
Tablet |
|
|
Develop a dissolution method |
|
|
2024/01/03 |
| Drospirenone/Ethinyl Estradiol/Levomefolate Calcium |
Tablet |
II (Paddle) |
50 |
Phosphate buffer pH 6.8, saline with 0.03 % ascorbic acid |
900 |
5, 10, 15, 20 and 30 |
2016/07/28 |
| Droxidopa |
Capsule |
|
|
Refer to FDA's Dissolution Guidance, 2018 |
|
|
2020/07/02 |
| Duetetrabenazine |
Tablet, Extended Release |
II (Paddle) with sinker |
75 |
50 mM potassium biphthalate buffer, pH 3.0 |
500 |
2, 4, 6, 8, 10, 12. 16 and 20 hours |
2023/11/30 |
| Duloxetine HCl |
Capsule (Delayed Release) |
|
|
Refer to USP |
|
|
2016/03/17 |
| Dutasteride |
Capsule (Soft-Gelatin) |
II (Paddle) |
50 |
Tier I: Dissolution Medium: 0.1 N HCI with 2% (w/v) sodium dodecyl sulfate (SDS) (900 mL) Tier II: Dissolution Medium: 0.1 N HCI with pepsin (as per USP) (450 mL) for the first 25 minutes, followed by addition of 0.1 N HCI with SDS (4% w/v) (450 mL) for the remainder of the dissolution test. |
900 |
15, 30, 45 and 60 |
2010/08/05 |
| Dutasteride/Tamsulosin HCl |
Capsule |
Dutasteride: II (Paddle) with sinker. Tamsulosin: II (Paddle) |
Dutasteride: 75 Tamsulosin: 50 |
Dutasteride::Tier I: Dissolution Medium: 1%w/v cetyltrimethylammonium bromide (CTAB) in 0.1 N HCl. Tier II: Dissolution Medium: 1% w/v CTAB in 0.1 N HCl with 0.16% w/v pepsin. Tamsulosin:: Acid Stage (0-2 hrs): 0.1 N HCl. Buffer stage: Add 250 mL of 0.2 M Sodium Phosphate Tribasic, Dodecahydrate pH 6.8 |
Dutasteride: 900. Tamsulosin: Acid stage: 750; Buffer stage: 1000 |
Dutasteride: 15, 30, 45 and 60 minutes. Tamsulosin: Acid Stage: 2 hours Buffer stage: 0.5, 1, 2, 3, 5, 7 and 10 hours |
2012/01/26 |
| Edaravone |
Suspension |
II (Paddle) |
75 |
pH 4.0 Acetate Buffer |
900 |
5, 10, 15, 20 and 30 |
2022/07/28 |
| Efavirenz |
Capsule |
|
|
Develop a dissolution method |
|
|
2023/09/15 |
| Efavirenz |
Tablet |
|
|
Develop a dissolution method |
|
|
2023/09/15 |
| Efavirenz 600 mg; Emtricitabine 200 mg; Tenofovir Disoproxil Fumarate 300 mg |
Tablet |
|
|
Develop a dissolution method |
|
|
2023/09/15 |
| Efavirenz/Lamivudine/Tenofovir Disoproxil Fumarate |
Tablet |
|
|
Develop a dissolution method |
|
|
2023/09/15 |
| Elacestrant Dihydrochloride |
Tablet |
II (Paddle) |
75 |
0.01 N HCl |
500 for 100 mg; 1000 for 400 mg |
5, 10, 15, 30, 45 and 60 |
2024/05/31 |
| Elagolix Sodium |
Tablet |
II (Paddle) |
50 |
0.05 M Sodium Phosphate, pH 6.8 |
900 |
5, 10, 15, 20, 30 and 45 |
2021/04/22 |
| Elagolix Sodium, Estradiol, Norethindrone Acetate; Elagolix Sodium |
Capsule |
Elagolix: I (Basket) |
Elagolix: 100 |
Elagolix: 0.05M Sodium Phosphate pH 6.8 |
|
10, 15, 20, 25, 30, 45, 60 and 90 |
2024/02/05 |
| Elbasvir/Grazoprevir |
Tablet |
I (Basket) |
100 |
Phosphate Buffer, pH 6.8 with 0.45% (w/v) Polysorbate 80 |
900 |
10, 15, 20, 30, 45 and 60 |
2016/07/28 |
| Eletriptan Hydrobromide |
Tablet |
I (Basket) |
100 |
0.1 N HCl |
900 |
5, 10, 15 and 30 |
2009/04/02 |
| Elexacaftor, Ivacaftor, Tezacaftor [FDC:ELE+ IVA+ TEZ]; Ivacaftor [IVA] |
Tablet/Tablet (Copackage) |
II (Paddle) |
FDC: ELE: 75/IVA: 65/TEZ:75; IVA: 75 |
FDA: ELE: 1.8% (v/v) Polysorbate 20 in 50 mM sodium phosphate, pH 6.8/ IVA: 0.4% (w/v) SLS in 50 mM sodium phosphate, pH 6.8/TEZ: 0.2% (w/v) SLS solution in 0.1N HCl; IVA: 1.8% (v/v) Polysorbate 20 in 50 mM sodium phosphate, pH 6.8 |
FDC: ELE: 900/IVA: 900/TEZ:900; IVA 900 |
5, 10, 15, 20 and 30 |
2021/08/19 |
| Eliglustat Tartrate |
Capsule |
|
|
Refer to FDA's Dissolution Guidance, 2018 |
|
|
2020/07/02 |
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