Stress condition | % assay of Iloperidone | % of degredants | Observation and mass balance | Peak purity |
Un-degraded | 99.1 |
| - | 1000 |
Acid hydrolysis (Conc. HCl, 24 h refluxed AT 110˚C - 120˚C) | 88.0 | 12.0 | Major unknown degradation product (11.4%) formed (Mass balance: 98.9%) | 995 |
Base hydrolysis (5 M NaOH, 24 h refluxed AT 110˚C - 120˚C) | 100.2 | Nil | No any known and unknown degradation product formed (Mass balance: 101.6%) | 995 |
Oxidation (30% H2O2, 15 min. AT Room Temp.) | 83.9 | 16.1 | Major known degradation impurity i.e. Imp-3 formed (13.9%). (Mass balance: 98.8%) | 1000 |
Thermal (105˚C, 7-days) | 99.9 | Nil | No any known and unknown degradation product formed (Mass balance: 100.4%) | 990 |
Photolytic as per ICH | 100.5 | Nil | No any known and unknown degradation product formed (Mass balance: 99.6%) | 1000 |