Stress condition |
%Total Impurities |
Study Time |
% Assay of active substance |
Mass balance
( % assay + % impurities +
% degradation products) |
Remarks |
Acid hydrolysis
(0.2 M HCl) |
21.0% |
2 h |
91.4 |
99.8 |
Prominent Degradation observed |
Water degradation
( at 80˚C) |
5.6% |
2 h |
93.6 |
99.6 |
Prominent Degradation observed |
Base hydrolysis
(0.2 M NaOH) |
2.8% |
1 h |
97.6 |
99.5 |
No Prominent Degradation observed |
Oxidation
(25H202) |
15.5 |
2 h |
84.8 |
98.6 |
Prominent Degradation observed |
Thermal (105˚C) |
26.0% |
24 h |
73.9 |
98.5 |
One major degradation
product was
formed RRT about xxx and identified the mass number at “705” |
Light(photolytic degradation) |
5.5% |
1200 KLUX/Hr |
99.1 |
99.5 |
Prominent Degradation observed |
