title: Quality assessment of compounded 17-hydroxyprogesterone caproate.
abstract: OBJECTIVE
  The purpose of this study was to evaluate the quality of compounded 17-hydroxyprogesterone caproate (17-OHPC).
  
  
  METHODS
  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.
  
  
  CONCLUSIONS
  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.affiliation: Department of Obstetrics, Gynecology and Reproductive Sciences, School of Medicine, University of Pittsburgh, Pittsburgh, PA.
authors.forename: Justine
authors.initials: J
authors.lastname: Chang
authors.affiliation: Department of Pharmaceutical Sciences, School of Pharmacy, University of Pittsburgh, Pittsburgh, PA.
authors.forename: Yang
authors.initials: Y
authors.lastname: Zhao
authors.affiliation: Department of Pharmaceutical Sciences, School of Pharmacy, University of Pittsburgh, Pittsburgh, PA.
authors.forename: Wenchen
authors.initials: W
authors.lastname: Zhao
authors.affiliation: Department of Pharmaceutical Sciences, School of Pharmacy, University of Pittsburgh, Pittsburgh, PA.
authors.forename: Raman
authors.initials: R
authors.lastname: Venkataramanan
authors.affiliation: Department of Obstetrics, Gynecology and Reproductive Sciences, School of Medicine, University of Pittsburgh, Pittsburgh, PA.
authors.forename: Steve N
authors.initials: SN
authors.lastname: Caritis
mesh_terms: D000077713:17 alpha-Hydroxyprogesterone Caproate; D004339:Drug Compounding / Q000592:standards*; D006801:Humans; D006908:Hydroxyprogesterones / Q000032:analysis / Q000592:standards*; D011749:Pyrogens; D011785:Quality Assurance, Health Care; D011786:Quality Control; D014481:United States
chemical_list: D006908:Hydroxyprogesterones; D011749:Pyrogens; D000077713:17 alpha-Hydroxyprogesterone Caproate
keywords: compounded 17-OHPC; impurity analysis; potency; sterility and pyrogen status