| Nifurtimox |
Tablet |
II (Paddle) |
100 |
Acetate Buffer, pH 4.5 with 1.0 % Sodium Dodecyl Sulfate (SDS) (for 30 mg strength) and 1.5 % SDS (for 120 mg strength) |
900 |
10, 20, 30, 60 and 75 |
2022/07/07 |
| Nilotinib HCl |
Capsule |
I (Basket) |
100 |
0.1 N HCl |
1000 |
10, 15, 20, 30 and 45 |
2024/02/05 |
| Nilotinib Hydrochloride Monohydrate |
Capsule |
I (Basket) |
100 |
0.1 N HCl |
1000 |
10, 15, 30 and 45 |
2009/10/30 |
| Nilotinib Tartrate |
Tablet |
II (Paddle) |
75 |
pH 6.8 Buffer with 1.25% CTAB |
1000 |
5, 10, 15, 20, 30, 45 and 60 |
2026/01/28 |
| Nilutamide |
Tablet |
|
|
Develop a dissolution method |
|
|
2009/05/20 |
| Nimodipine |
Capsule |
|
|
Develop a dissolution method |
|
|
2023/09/15 |
| Nintedanib Esylate |
Capsule |
II (Paddle) with sinker |
100 |
0.1 N HCl |
900 |
10, 15, 20, 30, 45 and 60 |
2015/09/03 |
| Niraparib |
Capsule |
II (Paddle) with sinker |
50 |
Tier 1: 0.08M Sodium Acetate Buffer, pH 4.0; Tier 2: 0.08M Sodium Acetate Buffer, pH 4.0 containing pepsin (750,000 units/L) |
900 |
10, 15, 20, 30, 45 and 60 |
2017/11/02 |
| Niraparib Tosylate |
Tablet |
II (Paddle) |
60 |
0.1 M Citrate buffer, pH 4.6 |
900 |
5, 10, 15, 20, 25, 30 and 45 |
2024/02/05 |
| Nirmatrelvir (NIR); Ritonavir (RIT) |
Tablet (copackage) |
II (Paddle) |
75 |
NIR: 0.05 M Sodium Phosphate, pH 6.8 with 0.2% Sodium Dodecyl Sulfate; RIT: Refer to USP |
900 |
15, 20, 30, 45 and 60 |
2024/08/05 |
| Nirogacestat Hydrobromide |
Tablet |
II (Paddle) |
75 |
pH 1.2 HCl buffer |
500 |
5, 10, 15, 20, 30, 45 and 60 |
2025/09/08 |
| Nisoldipine |
Tablet (Extended Release) |
II (Paddle) with option to use a sinker |
50 |
HCl with SLS (32.5 ± 0.1 g Sodium Lauryl Sulfate in 6489 mL of purified water containing 17.0 mL HCl, pH adjusted to 1.20 ± 0.05 with HCl) |
900 |
1, 4, 8, 12, 15, 18 and 24 hours |
2009/04/02 |
| Nitazoxanide |
Tablet |
II (Paddle) |
75 |
Phosphate buffer at pH 7.5 with 6% hexadecyltrimethyl ammonium bromide, bath temperature at 25ºC |
900 |
10, 20, 30, 45, 60 |
2007/01/03 |
| Nitazoxanide |
Oral Suspension |
II (Paddle |
100 |
Phosphate buffer at pH 7.5 with 6% hexadecyltrimethyl ammonium bromide, bath temperature at 25ºC |
900 |
10, 20, 30, 45 and 60 |
2010/10/21 |
| Nitisinone |
Tablet |
II (Paddle) |
50 |
Phosphate Buffer, pH 6.8 |
2 mg tablets: 500 mL; 5 mg and 10 mg tablets: 900 mL |
10, 15, 20, 30, 45, 60, 75 and 90 |
2018/02/15 |
| Nitisinone |
Capsule |
II (Paddle) with sinker |
50 |
Phosphate Buffer, pH 6.8 |
1000 |
5, 10, 15, 20, 30 and 45 |
2017/11/02 |
| Nitisinone |
Suspension |
II (Paddle) |
50 |
pH 1.2 HCl Buffer (degassed) |
1000 |
10, 15, 20, 30 and 45 |
2016/12/22 |
| Nitrofurantoin |
Capsule |
|
|
Refer to USP |
|
|
2009/04/02 |
| Nitrofurantoin |
Suspension |
II (Paddle) |
50 |
Phosphate Buffer, pH 7.2 |
900 |
15, 30, 60, 120 and 180 |
2009/04/02 |
| Nitroglycerin |
Tablet (Sublingual) |
II (Paddle) |
50 |
Phosphate Buffer, pH 6.5 |
500 |
1, 3, 5, 8, and 10 |
2010/01/15 |