Include All Stability Dimensions: Chemical, Physical, and Functional Parameters
Understanding the Tip: Why stability studies must be multidimensional: Stability testing must go beyond chemical assay and impurities. A true stability program must evaluate three critical aspects of product quality: chemical (potency and degradation), physical (appearance, viscosity, dissolution), and functional (performance-specific parameters such as drug release, reconstitution, or device actuation). Each parameter contributes to ensuring…
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