ABSTRACT
The purpose of stability testing is to provide evidence on how the quality of the dosage
form 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 product and rec-
ommended storage conditions. The attributes that are monitored during stability studies
are assay, degradation products, dissolution or disintegration, description and, if present,
antioxidant content. Any of these attributes can define the shelf life and storage con-
ditions for the product. The shelf life should not exceed that predicted for any single
attribute.
