Question

What is the accelerated stability study, what is the purpose of it? Design simple experiment to show how you conduct the study and what kind of calculations you make to evaluate the stability of the drug.

Answer 1

In accelerated stability study, a product is stressed at several high (warmer than ambient) temperatures and the amount of heat input required to cause product failure is determined.

The purpose of stability testing is to predict the shelf life of the product, by accelerating the rate of decomposition, preferably by increasing the temperature of reaction conditions.

The concept of accelerated stability study is based upon the Arrhenius equation. These equations describe the relationship between storage temperatures and degradation rate. Using Arrhenius equation, projection of stability from the degradation rates observed at high temperatures for some degradation processes can be determined. When the activation energy is known, the degradation rate at low temperatures may be projected from those observed at “stress” temperatures.