| Gilteritinib Fumarate |
Tablet |
II (Paddle) |
50 |
0.1 N HCl |
900 |
10, 15, 20, 30 and 45 |
2020/08/27 |
| Glimepiride |
Tablet |
II (Paddle) |
75 |
Phosphate Buffer, pH 7.8 |
900 |
5, 10, 15 and 30 |
2004/07/23 |
| Glimepiride/Pioglitazone HCl |
Tablet |
II (Paddle) |
75 |
For Pioglitazone: pH 2.0, HCl Buffer. For Glimepiride: pH 6.8, Sodium Phosphate Buffer with 0.2% sodium dodecyl sulfate |
900 |
For Pioglitazone: 10, 15, 20, 30 and 45; For Glimepiride: 10, 15, 20 and 30 |
2009/04/02 |
| Glimepiride/Rosiglitazone Maleate |
Tablet |
II (Paddle) |
75 |
0.01 M HCl with 0.5% Sodium Dodecyl Sulfate |
900 |
5, 10, 15, 30, 45 and 60 |
2007/01/03 |
| Glipizide |
Tablet (Extended Release) |
II (Paddle) |
50 |
Simulated Intestinal Fluid without pancreatin, pH 7.5 |
900 |
1, 2, 4, 8, 16 hours and until at least 80% dissolved |
2008/04/10 |
| Glipizide |
Tablet |
|
|
Refer to USP |
|
|
2010/08/05 |
| Glipizide/Metformin HCL |
Tablet |
|
|
Refer to USP |
|
|
2008/12/18 |
| Glyburide (Micronized) |
Tablet |
II (Paddle) |
50 |
0.05 M Phosphate Buffer, pH 7.5 |
900 |
10, 20, 30, 45 and 60 |
2004/02/02 |
| Glyburide (Non-micronized) |
Tablet |
II (Paddle) |
75 |
0.05 M Borate Buffer, pH 9.5 |
500 |
10, 20, 30, 45 and 60 |
2004/02/02 |
| Glyburide/Metformin HCl |
Tablet |
|
|
Refer to USP |
|
|
2008/01/14 |
| Glycopyrrolate |
Tablet, Oral Disintegrating |
|
|
Refer to FDA's Dissolution Guidance, 2018 |
|
|
2025/09/08 |
| Glycopyrrolate |
Tablet |
|
|
Refer to FDA's Dissolution Guidance, 2018 |
|
|
2020/07/02 |
| Goserelin Acetate |
Implant |
Prior to sampling, the jar is removed from incubation and mechanically swirled with digital orbital shaker |
Swirl orbit of 50 mm at 205 rpm for 6 seconds |
Each implant should be incubated in 50 mL of phosphate buffered saline, pH 7.4, at 39°C (warmed overnight before the implants are added), in a 120-mL Wheaton jar. |
50 |
3, 14, 35, 56 and 84 days (10.8 mg strength); 7, 14, 17, 21 and 28 days (3.6 mg strength) |
2008/11/04 |
| Granisetron |
Injectable (Extended Release) |
|
|
Develop a method to characterize in vitro release |
|
|
2016/12/22 |
| Granisetron |
Film, Transdermal (Extended Release) |
VI (Cylinder) |
50 |
80 microL /L phosphoric acid (85%) at 32 ± 0.5°C |
1000 |
2, 6, 12, 24, 36, 48, 60, 72 and 96 hours |
2011/03/03 |
| Granisetron HCl |
Tablet |
|
|
Refer to FDA's Dissolution Guidance, 2018 |
|
|
2020/07/02 |
| Griseofulvin |
Oral Suspension |
|
|
Develop a dissolution method |
|
|
2023/09/15 |
| Griseofulvin (Microcrystalline) |
Oral Suspension |
|
|
Develop a dissolution method |
|
|
2023/09/15 |
| Griseofulvin (Microcrystalline) |
Tablet |
|
|
Develop a dissolution method |
|
|
2024/01/03 |
| Griseofulvin (Ultramicrocrystalline) |
Tablet |
|
|
Develop a dissolution method |
|
|
2024/01/03 |