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Accelerated Stability Study Results
| Sr. no | Test | Specification | 40 ± 2°C, 75 ± 5% RH | |
|---|---|---|---|---|
| Initial | 12th week | |||
| 1 | Color | Off-white tablet | No color change | No color change |
| 2 | Hardness (kp) | 6.5 ± 0.5 | 6.5 ± 0.5 | 6.5 ± 0.5 |
| 3 | Thickness (mm) | 4.00 ± 0.5 | 4.09 ± 0.09 | 4.08 ± 0.08 |
| 4 | In vitro dissolution (%) | 30 min (50–70%) | 53.62 ± 1.71 | 51.24 ± 1.93 |
| 90 min (70–85%) | 70.28 ± 2.12 | 70.07 ± 1.08 | ||
| 240 min (NLT 90%) | 94.37 ± 1.99 | 93.66 ± 1.99 | ||
| 5 | Assay (%) | 90–110 | 99.36 ± 1.54 | 98.72 ± 2.64 |
R H relative humidity
