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 expiration dates on labels must 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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