Abstract

Identifying the Criteria of a Valid Stability Study

Author(s): Williams LaVonn A, Hastings Mitchell Blaine

Issue: Jan/Feb 2009 - Compounding for Pediatrics

Page(s): 32-36

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Abstract

The objective of a stability study is to establish specifi cations for the storage of a drug substance or active ingredient, and to ensure 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.

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