Quality assessment of compounded 17-hydroxyprogesterone caproate.

Chang, Justine; Zhao, Yang; Zhao, Wenchen; Venkataramanan, Raman; Caritis, Steve N; Obstetrical-Fetal Pharmacology Research Units Network · Am J Obstet Gynecol · 2014

other · Level V

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Abstract

The purpose of this study was to evaluate the quality of compounded 17-hydroxyprogesterone caproate (17-OHPC). Compounded 17-OHPC that was obtained from 15 compounding pharmacies throughout the United States was analyzed for potency, impurities, sterility, and pyrogen status. Eighteen samples were supplied by 15 compounding pharmacies. The concentration of 17-OHPC in all samples was within the specification limits, and all tested samples passed sterility and pyrogen testing. Only 1 of 18 samples was out of specification limits for impurities. Compounded 17-OHPC that was obtained from 15 pharmacies throughout the United States did not raise safety concerns when assessed for potency, sterility, pyrogen status, or impurities.

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