Stability of drugs
Stability is defined as the ability of a drug substance or drug product to retain its chemical, physical, microbiological and biological properties within specified limits throughout its shelf life.
The purpose of stability testing is to provide evidence on how the quality of a drug substance or drug product varies with time under the influence of a variety of environmental factors, such as temperature, humidity and light, and to establish a shelf life for the drug substance or drug product and recommended storage conditions for the drug substance or drug product.
Accelerated stability studies are designed to increase the rate of chemical degradation and/or physical change of a drug substance or drug product by using exaggerated storage conditions with the purpose of monitoring degradation reactions and predicting the shelf life under normal storage conditions. Ref: www.ich.org
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