A Guide to Outsourced Stability Storage
Manufacturers conduct Stability Studies to establish shelf life. Shelf life of a product is ascertained under controlled environmental conditions such as humidity, temperature or light.
Stability studies are an evaluation of the risk of product degrading in different markets within different climatic zones.
Stability studies are important as the manufacturer has responsibility for the product from formulation to consumption and must ensure that the formulation does not lose its potency or result in degradation by-products that can do more harm than good to the consumer. The shelf life of a product is typically assessed either by real-time or accelerated stability trials.
The stability programme should also examine factors that influence its quality, for example, interaction of API with excipients, container closure systems and packaging materials.
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- Wendy Cullen Head of UK Sales - Stability Storage - Source Bioscience