Table 1. Storage conditions requested by guideline ICH Q1A for the development of new drug products.
Study | Storage condition | Minimum time period covered by data at submission |
Long term* | 25°C ±2°C/60% RH ±5% RH or 30°C ±2°C/65% RH ±5% RH | 12 months |
Intermediate** | 30°C ±2°C/65% RH ±5% RH | 6 months |
Accelerated | 40°C ±2°C/75% RH ±5% RH | 6 months |
It is up to the applicant to decide whether long term stability studies are performed at 25°C ±2°C/60% RH ±5% RH or 30°C ±2°C/65% RH ±5% RH.
If 30°C ±2°C/65% RH ±5% RH is the long-term condition, there is no intermediate condition.