Development and Validation of Stability Indicating Methods

Stability Studies seek to establish the overall stability of a drug substance or analyte, specifically, changes in the products after being exposed to various conditions.

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Ensuring Drug Stability with Comprehensive Testing and Validation for Reliable Results

Method development is required to identify the possible degradation in products and determine conditions for the stability testing, including the effects of temperature, humidity or other means of stress upon the product. The final method used to analyze the test material and degradants must be a validated method encompassing parameters for linearity, limits of detection and quantitation, robustness, accuracy/recovery, and precision. (See, Validation of Methods)

Apart from the changes to the product itself, stability studies also seek to identify leachables that might have transferred from the packaging material into the product.