Stress condition | % of Apixaban | % of degredants | Observation and mass balance | Peak purity |
Un-degraded | 100 | - | - | 1.0000 |
Acid hydrolysis (1 M HCl, 24 h at Room Temp.) | 90.91 | 9.09 | Major unknown degradation product (3.2%) formed (Mass balance: 102.03%) | 1.0000 |
Base hydrolysis (1 M NaOH, 2 h at Room Temp.) | 71.25 | 28.75 | Major unknown degradation product (20.06%) formed (Mass balance: 101.55%) | 1.0000 |
Oxidation (15% H2O2, 24 h. at Room Temp.) | 99.43 | 0.57 | No any known and unknown major degradation product formed (Mass balance: 101.78%) | 1.0000 |
Thermal (105˚C, 7-days) | 100 | Nil | No any known and unknown degradation product formed (Mass balance: 98.69%) | 1.0000 |
Photolytic as per ICH | 100 | Nil | No any known and unknown degradation product formed (Mass balance: 98.07%) | 1.0000 |