ICH Storage Condition Guidelines (35)
| Study | Storage Conditions | Minimum Time Period Covered by Data at Submission |
|---|---|---|
| Long term | 25 ± 2 °C–60% ± 5% RH or 30 ± 2 °C–65% ± 5% RH | 12 months |
| Intermediate | 30 ± 2 °C –65% ± 5% RH | 6 months |
| Accelerated | 40 ± 2 °C –75% ± 5% RH | 6 months |
RH = relative humidity.