Typically, both drug substance and drug product are tested in at least two different storage conditions: long term ambient storage temperature and accelerated conditions predicting product stability at a long period of time.
The purpose of stability testing is to understand how the quality of an Active Pharmaceutical Ingredient (API) varies when different environmental factors such as temperature, humidity and light are introduced. Stability testing also includes the study of product related factors that influence the quality of a drug, for example, interaction of API with excipients, container closure systems and packaging materials.
Stability testing is the process by which pharmaceutical manufacturers observe their product over predetermined lengths of time in specific environmental conditions to determine if there is any change in the quality of the Active Pharmaceutical Ingredient (API) or Final Product (FP).
WHO guidelines on stability testing of pharmaceutical products containing well-established drug substances in conventional dosage forms
.JPG)
0 Comments