Stability Testing
TestingAlso known as: Shelf-life testing, Accelerated stability, Real-time stability
Testing to determine how long a product maintains potency and safety under storage conditions.
What It Means
Stability testing evaluates how a product's physical, chemical, and microbiological properties change over time under defined conditions (temperature, humidity, light). Results determine expiration dates and shelf-life claims. ICH guidelines (Q1A-Q1E) provide internationally recognized protocols. Accelerated stability (elevated temp/humidity) predicts real-time stability faster but is less definitive.
What It Is Not
Stability testing is NOT required by 21 CFR Part 111, but FDA says any expiration date placed on a label should be supported by data. Products without stability data should not carry expiration dates. Accelerated stability is a prediction. Real-time data is the gold standard.
Evidence and References
- standardICH Q1A(R2) Stability Testing
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