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Abstract:  Potency testing (i.e., analysis of the concentration of the active ingredient) is an important part of the quality-control process for compounded preparations. However, concerns about the reliability and interpretation of potency testing results have been raised by compounding professionals. Standards detailed in United States Pharmacopeia Chapter <795> allow nonsterile preparations to be within 90% to 110% of the theoretical calculated and labeled quantity of active ingredient. Variability among independent testing laboratories could have significant implications for interpretation of whether a compounded preparation meets these standards. The primary goal of this study was to characterize the variability among analytical testing laboratories when analyzing the potency of a nonsterile, compounded hormone cream (specifically, estradiol) and an estradiol stock solution used to compound the cream. Blinded to the theoretical concentration of the active ingredient, three analytical testing labs were sent samples

Related Keywords: estradiol, potency testing, quality control, analytical testing laboratories, estrogen, topical preparations, transdermal administration, United States Pharmacopeia, quality standards, USP Chapter <795>

Related Categories: PEER-REVIEWED, QUALITY CONTROL, UNITED STATES PHARMACOPEIA CONVENTIONS, DOSAGE FORMS/DRUG CARRIERS

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