How to Set Up A Stability Budget
Many pharmaceutical manufacturers use data from the extensive product stability studies to determine the minimum and maximum allowed temperatures and time out of storage during transport.
Determining the product’s thermal stability (the product's ability to resist, under specified conditions, irreversible changes in its identity, strength, quality, and purity at various temperatures above and below the specified storage range) is the first step.
As one can imagine, time is of the essence, especially when developing a new drug substance. Therefore, instead of solely relying on real-time stability tests that may take years, most pharmaceutical manufacturers also choose to conduct accelerated stability studies and predict the shelf life using the Arrhenius equation.
In these accelerated tests, the products are exposed to defined sets of elevated temperatures, for example, (25°C, 30°C, 40°C), and potency tested after defined periods (e.g., six days, 28 days, three months, 12 months, 24 months, and 36 months).