Table 2.
Stability of LMN-NKA (1.5 mg and 5 mg) in ODT under long-term storage conditions (25 °C/60% relative humidity) and under accelerated conditions (40 °C/75% relative humidity) for up to 90 days. Data shown as mean ± SD (N=3).
| Condition (°C/%RH) |
Claimed Strength (mg) |
Day14 | Day 28 | Day 90 | |||
|---|---|---|---|---|---|---|---|
| Actual Strength (mg) |
% Label Claim |
Actual Strength (mg) |
% Label Claim |
Actual Strength (mg) |
% Label Claim |
||
| 25/60 | 1.5 | 1.59 ± 0.03 | 106.4 ± 2.0 | 1.56 ± 0.01 | 103.8 ± 0.8 | 1.46 ± 0.02 | 97.2 ± 1.6 |
| 25/60 | 5 | 5.03 ± 0.06 | 100.7 ±1.3 | 5.23 ± 0.05 | 104.7 ± 1.0 | 5.11 ± 0.02 | 102.2 ± 0.3 |
| 45/75 | 1.5 | 1.59 ± 0.08 | 105.7 ± 5.5 | 1.59 ± 0.08 | 104.6 ± 0.7 | 1.46 ± 0.02 | 97.4 ± 1.1 |
| 45/75 | 5 | 4.96 ± 0.06 | 99.1 ± 1.2 | 4.82 ± 0.23 | 96.5 ± 4.5 | 4.92 ± 0.11 | 98.4 ± 2.3 |