The term ‘Stability’ can be defined as the period of time in which a product remains stable under the recommended conditions (as different products require different conditions), without compromising its integrity. This means that no physical or chemical changes occur, and the product retains the same quality as when it left the manufacturer. When a company is manufacturing a new product, it needs to perform a stability study.
These studies are performed with the goal of determining the shelf life (without compromising its composition), and appropriate storage conditions for the product. During the first year of manufacture, three initial batches are selected for the Stability Study. The following years, one batch, per strength, per year is selected to be put on stability. This is done to monitor ongoing quality and ensure that while the product is still on the market, it remains within specification. Such studies can be performed on pharmaceutical products, food and beverage products, cosmetics and also packaging.
This article will focus on Stability Studies performed for pharmaceutical products.