7
Stability Testing of Active Substances and Pharmaceutical Products
The purpose of stability testing is to provide evidence on how the quality of an active substance or pharmaceutical product varies with time under the influence of a variety of environmental factors such as temperature, humidity and light. In addition, product-related factors influence the stability, for example, the physical and chemical properties of the active substance, pharmaceutical excipients, dosage form and its composition, manufacturing process, nature of the container-closure system and the properties of the packaging materials. The result of the stability testing determines the shelf life of the pharmaceutical product and storage conditions can be recommended. ...
Get Pharmaceutical Technology, 1/e now with the O’Reilly learning platform.
O’Reilly members experience books, live events, courses curated by job role, and more from O’Reilly and nearly 200 top publishers.
