Identifying the criteria of a valid stability study.

The objective of a stability study is to establish specifications for the storage of a drug substance or active ingredient, and to esure that the correct beyond-use date is assigned by demonstrating stability throughout its shelf life. Certain criteria must be met for a study to be considered a valid stability study. The purpose of this article is to clarify the criteria for a valid stability study so compounding pharmacists will understand what to look for when reviewing a stability study to determine an appropriate beyond-use date for compounded preparations.