Table 8. .
Stability data for Melperone CR Capsules and ODT-CR 2.
| Attribute |
Initial |
25°C/60%RH |
40°C/75%RH |
|||
|---|---|---|---|---|---|---|
| Stability time point → | 3 Mo | 6 Mo | 1 Mo | 3 Mo | 6 Mo | |
| Melperone CR Capsules | ||||||
| Assay (%) | 97.0 | 98.6 | 97.9 | 98.5 | 98.0 | 97.7 |
| Time (hrs) | % Drug Released | |||||
| 2 | 29 | 31 | 28 | 25 | 26 | 25 |
| 4 | 55 | 55 | 53 | 49 | 47 | 48 |
| 8 | 78 | 77 | 76 | 75 | 74 | 75 |
| 12 | 88 | 87 | 86 | 86 | 85 | 86 |
| 16 | 93 | 92 | 91 | 92 | 92 | 92 |
| 24 | 99 | 97 | 97 | 98 | 99 | 97 |
| Specified impurity | ND | ND | ND | ND | ND | <LOQ |
| Unspecified | * | * | * | * | * | * |
| Total | 0.01% | 0.00% | 0.00% | 0.00% | 0.00% | 0.00% |
| Moisture | 1.3% | 1.3% | 1.6% | 1.3% | 1.3% | 1.6% |
| Melperone ODT-CR 2 | ||||||
| Assay (%) | 103.9 | 102.8 | 103.5 | 103.9 | 102.8 | 103.5 |
| Time (hrs) | % Drug Released | |||||
| 2 | 28 | 30 | 30 | 29 | 30 | 30 |
| 4 | 58 | 60 | 60 | 60 | 60 | 60 |
| 8 | 84 | 86 | 87 | 86 | 86 | 86 |
| 12 | 93 | 90 | 90 | 96 | 95 | 95 |
| 16 | 98 | 101 | 101 | 101 | 100 | 100 |
| 24 | 104 | 106 | 106 | 106 | 107 | 105 |
| Specified impurity | <LOQ | 0.01% | 0.01% | 0.01% | 0.01% | 0.01% |
| Unspecified | * | * | * | * | * | * |
| Total | 0.04% | 0.05% | 0.03% | 0.01% | 0.10% | 0.10% |
| Moisture | 1.9% | 1.8% | 1.7% | 1.9% | 1.9% | 2.0% |
ND → Not detected or below limit of quantitation, <LOQ; Specified, identified impurity, HBA at 0.53 RRT not detected
* → Unspecified impurities at RRTs 0.29, 0.40, 0.52, 0.65, 0.69/0.71, 0.84, 1.20, 1.51, 1.57, 1.68/ 1.70, 1.83, 2.09, 2.28, 2.50, 2.74/1.84, 3.02, 3.73: 0.01%, not detected, or <LOQ. Unspecified impurity peaks with RRTs in bold were observed only at 0 time.