Quality assessment of compounded 17-hydroxyprogesterone caproate

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• 作者：Justine Chang ; Yang Zhao ; Wenchen Zhao ; Raman Venkataramanan ; Steve N. Caritis ; Obstetrical-Fetal Pharmacology Research Units Network
• 关键词：compounded 17-OHPC ; impurity analysis ; potency ; sterility and pyrogen status
• 刊名：American Journal of Obstetrics and Gynecology
• 出版年：January, 2014
• 年：2014
• 卷：210
• 期：1
• 页码：47.e1-47.e7
• 全文大小：325 K

文摘

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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聽pharmacies throughout the United States did not raise safety concerns when assessed for potency, sterility, pyrogen status, or impurities.