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Pharmacological Stability

Meaning

Pharmacological stability is a critical quality attribute of a drug product, referring to the extent to which the active pharmaceutical ingredient (API) and its excipients retain their chemical, physical, microbiological, and biopharmaceutical properties throughout their storage and use. This property ensures that the drug maintains its identity, strength, quality, and purity, thereby guaranteeing its safety and efficacy over its designated shelf-life. Instability can lead to therapeutic failure or the formation of harmful degradation products.