STABILITY TESTING

‘Stability testing is a routine procedure performed on drug
substances and products and is employed at various stages of the product development. In early stages, accelerated stability testing (at relatively high temperatures and/or humidity) is used in order to determine the type of degradation products which may be found after long-term storage. Testing under less rigorous conditions i.e. those recommended for long-term shelf storage, at slightly elevated temperatures is used to determine a product’s shelf life and expiration dates.