Table 1.
Conditions mostly used for forced degradation studies.
| Degradation type | Experimental conditions | Storage conditions | Sampling time (days) |
|---|---|---|---|
| Hydrolysis | Control API (no acid or base) | 40 °C, 60 °C | 1,3,5 |
| 0.1 M HCl | 40 °C, 60 °C | 1,3,5 | |
| 0.1 M NaOH | 40 °C, 60 °C | 1,3,5 | |
| Acid control (no API) | 40 °C, 60 °C | 1,3,5 | |
| Base control (no API) | 40 °C, 60 °C | 1,3,5 | |
| pH: 2,4,6,8 | 40 °C, 60 °C | 1,3,5 | |
| Oxidation | 3% H2O2 | 25 °C, 60 °C | 1,3,5 |
| Peroxide control | 25 °C, 60 °C | 1,3,5 | |
| Azobisisobutyronitrile (AIBN) | 40 °C, 60 °C | 1,3,5 | |
| AIBN control | 40 °C, 60 °C | 1,3,5 | |
| Photolytic | Light 1× ICH | NA | 1,3,5 |
| Light 3× ICH | NA | 1,3,5 | |
| Light control | NA | 1,3,5 | |
| Thermal | Heat chamber | 60 °C | 1,3,5 |
| Heat chamber | 60 °C/75% RH | 1,3,5 | |
| Heat chamber | 80 °C | 1,3,5 | |
| Heat chamber | 80 °C/75% RH | 1,3,5 | |
| Heat control | Room temp. | 1,3,5 | |
Ref.: [17].
NA: Not applicable.