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Stability and Shelf Life
The document outlines the complex processes of stability testing for pharmaceutical products, including methods such as real-time, accelerated, retained sample, and cyclic temperature stress testing. It emphasizes the importance of these tests in determining a product's shelf life and ensures regulatory approval by evaluating various factors that influence stability. Estimating shelf life also requires specific statistical analyses based on long-term storage studies to determine expiration dates under recommended storage conditions.
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