| Stress condition |
Conc. μg/mL |
%Degradation |
Major degradant |
Purity angle |
Purity Threshold |
Mass balance |
| Non stressed |
512 |
- |
- |
0.10 |
2.2 |
100 |
| Acid hydrolysis |
495 |
12.6% |
Imp-A&C |
0.15 |
2.45 |
99.2 |
| Base hydrolysis |
502 |
18.1% |
Imp-A&C |
0.22 |
3.22 |
98.8 |
| Oxidation |
515 |
3.2% |
Imp-A |
0.25 |
2.66 |
99.1 |
| Heat and humidity |
501 |
No significant |
9.11 |
0.19 |
1.72 |
99.2 |
| Photo stability |
511 |
No significant |
8.22 |
0.26 |
3.55 |
99.4 |
| Dry heat |
509 |
5.4% |
Imp-A |
`0.13 |
3.75 |
99.7 |
|
