Table 3 Degradation study data for diltiazem hydrochloride tablets
Stress condition | % Total Imp | % Assay Diltiazem | % Mass Balance | Purity Angle | Purity Threshold | Purity Flag |
|---|---|---|---|---|---|---|
0.5 N HCl/80 ℃ in water bath for 2 h | 7.21 | 90.17 | 97.4 | 0.070 | 0.278 | No |
0.5 N NaOH/80 ℃ in water bath for 2 h | 6.88 | 90.92 | 97.8 | 0.068 | 0.283 | No |
5% H2O2 for 24 h at room temperature | 3.45 | 97.45 | 100.9 | 0.051 | 0.243 | No |
Humidity/ (40 °C /75%RH) for 5 days | 0.28 | 99.84 | 100.1 | 0.546 | 2.455 | No |
Thermal/80 °C/48 h | 0.32 | 99.83 | 100.2 | 0.594 | 2.427 | No |
Photolytic/250 Wh/m2/1.2 million Lux hours | 0.26 | 99.86 | 100.1 | 0.586 | 2.444 | No |