Table 2.
Summary of forced degradation results.
| Stress condition | % Total impurities | Study time | % Assay of active substance | Mass balance (% assay + % impurities + % degradation products) | Remarks |
|---|---|---|---|---|---|
| Acid hydrolysis (1 M HCI) | 8.4% | 2 h | 91.4 | 99.8 | Prominent degradation observed |
| Base hydrolysis (0.5 M NaOH) | 19.8% | 1 h | 79.7 | 99.5 | One major degradation product was formed RRT about 0.31 and identified as “Methyl hydrogen 9, 11 dihydroxy, 17-α-hydroxy-3-oxopregn 7-α-carbonate, 21-α-carboxylic acid” |
| Oxidation (15% H2O2) | 19.2% | 4 h | 78.5 | 97.7 | Prominent Degradation observed |
| Thermal (100°C) | 0.3% | 7 days | 99.3 | 99.6 | No degradation products formed |
| Light (photolytic degradation) | 0.4% | 1200 KLUX/Hr | 99.1 | 99.5 | No degradation products formed |