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Physicochemical Instability

Meaning

Physicochemical Instability refers to the susceptibility of a pharmaceutical or nutraceutical formulation to undergo undesirable chemical degradation or physical changes over time, compromising its quality, safety, and therapeutic potency. Chemical instability involves the breakdown of the active ingredient through reactions like hydrolysis or oxidation, while physical instability relates to changes in the product’s appearance, such as phase separation in emulsions or alterations in particle size. This instability directly impacts a product’s shelf-life and efficacy in a clinical setting.