Table 3.
Stability of film-coated test tablet and the reference soft capsule of choline alfoscerate (400 mg) after 3 months of storage under the accelerated condition (40°C/75% RH)
| Test variables | Test | Reference | ||
|---|---|---|---|---|
| Initial | 3 months | Initial | 3 months | |
| Appearance | Light yellow Oblong type |
 No change |
Pale yellow Oval type |
 Deform |
| Disintegration time (n=6) |
9 minutes | 9 minutes | 10 minutes | 12 minutes |
| Assaya (n=3) |
100.1%±1.3% | 101.9%±0.4% | 99.9%±1.0% | 101.2%±1.2% |
| Hardnessa (n=3) |
21.0±0.8 kp | 20.7±1.2 kp | – | – |
Note:
a
Values are expressed as mean ± SD.
Abbreviation: RH, relative humidity.