General Case for Testing Stability of Drug Products. Study Storage Condition Minimum Time Period Covered by Data at Submission Long Term* 25o ±2oC/60%±5%RH or 30o ±2oC/65%±5%RH 12 months Intermediate** 30o ±2oC/65%±5%RH 6 months Accelerated 40o ±2oC/75%±5%RH 6 months  * It is up to the applicant to decide whether long-term stability studies are performed at 25o ±2oC/60%±5%RH  or 30o ±2oC/65%±5%RH ** If 30o ±2oC/65%±5%RH is the long-term condition there is no intermediate condition.

Source: Pharmaceutical and Medical Packaging News Jan 2004 from Q1A(R2)Stability Testing of New Drug Substances and Products.
For more information please visit www.fda.gov/ohrms/dockets/98fr/2002d-0231-gdl0002.pdf

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