Justine Chang1, Yang Zhao2, Wenchen Zhao2, Raman Venkataramanan2, Steve N Caritis1. 1. Department of Obstetrics, Gynecology and Reproductive Sciences, School of Medicine, University of Pittsburgh, Pittsburgh, PA. 2. Department of Pharmaceutical Sciences, School of Pharmacy, University of Pittsburgh, Pittsburgh, PA.
Abstract
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.
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.
Authors: Paul J Meis; Mark Klebanoff; Elizabeth Thom; Mitchell P Dombrowski; Baha Sibai; Atef H Moawad; Catherine Y Spong; John C Hauth; Menachem Miodovnik; Michael W Varner; Kenneth J Leveno; Steve N Caritis; Jay D Iams; Ronald J Wapner; Deborah Conway; Mary J O'Sullivan; Marshall Carpenter; Brian Mercer; Susan M Ramin; John M Thorp; Alan M Peaceman; Steven Gabbe Journal: N Engl J Med Date: 2003-06-12 Impact factor: 91.245
Authors: David B Nelson; Donald D McIntire; Jeffrey McDonald; John Gard; Paula Turrichi; Kenneth J Leveno Journal: Am J Obstet Gynecol Date: 2017-02-20 Impact factor: 8.661