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Microbiological Stability

Meaning

Microbiological Stability, within the domain of pharmaceutical compounding, refers to the extent to which a finished drug product retains its resistance to microbial proliferation throughout its designated storage and use period. It is one of the five essential components of overall drug stability, alongside chemical, physical, therapeutic, and toxicological stability. Ensuring this characteristic is vital, particularly for non-sterile compounded hormonal preparations, as microbial contamination can render a medication unsafe, leading to infection or a degradation of the active pharmaceutical ingredient.