Stress condition

% assay of Apremilast

% of degredants

Observation and mass balance

Peak purity

Un-degraded

99.13 %

0.87

-

1.0000

Acid hydrolysis (0.1 M HCl, 15 min at room temperature)

93.25

6.75

Major unknown degradation product (2.79%) formed

(Mass balance: 92.93%)

1.0000

Base hydrolysis (0.1 M NaOH, 15 min at room temperature)

91.54

8.47

Major unknown degradation product (3.40%) formed

(Mass balance: 90.59%)

1.0000

Oxidation (15% H₂O₂, 15 min. at Room Temp.)

100.0

Nil

No any known and unknown degradation product formed

(Mass balance: 100.29%)

1.0000

Thermal (105˚C, 5-days)

99.68

0.32

No any known and unknown degradation product formed

(Mass balance: 98.09%)

1.0000

Photolytic as per ICH (1.2 Million Lux hr.)

100.0

Nil

No any known and unknown degradation product formed

(Mass balance: 100.0%)

1.0000