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