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Identifying the Criteria of a Valid Stability Study

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

Issue:  Jan/Feb 2009 - Compounding for Pediatrics
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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.

Related Keywords: LaVonn A. Williams, Mitchell Blaine Hastings, stability studies, stability-indicating assays, reporting standards, quality standards, stability tests, children, dosage forms, beyond-use dating

Related Categories: STABILITIES, COMPATIBILITIES, QUALITY CONTROL, DOSAGE FORMS/DRUG CARRIERS, INFORMATION RESOURCES

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