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. 2013 Nov 11;8(11):e79041. doi: 10.1371/journal.pone.0079041

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.