Objective: The purpose of this study was to evaluate the quality of compounded 17-hydroxyprogesterone caproate (17-OHPC).
Study design: Compounded 17-OHPC that was obtained from 15 compounding pharmacies throughout the United States was analyzed for potency, impurities, sterility, and pyrogen status.
Results: 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.
Conclusion: 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.
Keywords: compounded 17-OHPC; impurity analysis; potency; sterility and pyrogen status.
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