Table 6 Summary of force degradation studies
Name | Time (h) | Assay (%w/w) in degradation sample | Mass balance (assay + total impurity) | Remark | Peak purity |
|---|---|---|---|---|---|
Acid Degradation (0.2 N HCL) | 6 h | 98.43 | 99.99 | Two degradation peaks peak 1 and peak2 were observed | Pass |
Base Degradation (0.2N NaOH) | 24 h | 99.94 | 99.98 | No degradation was observed | Pass |
Oxidation (H2O2 30%) | 6 h | 99.72 | 100.1 | No degradation was observed | Pass |
Thermal (105 °C) | 5 days | 99.53 | 100.1 | One degradation peak 1 was observed | Pass |
Photolysis (sunlight) | 3 days | 99.82 | 100.3 | One degradation peak 1 was observed | Pass |