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