title: Identifying the criteria of a valid stability study.
abstract: 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.
authors: International Journal of Pharmaceutical Compounding, Edmond, Oklahoma.
authors: Lavonn A
authors: LA
authors: Williams
authors: Mitchell Blaine
authors: MB
authors: Hastings