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Volumn 210, Issue 1, 2014, Pages 47.e1-47.e7

Quality assessment of compounded 17-hydroxyprogesterone caproate

Author keywords

compounded 17 OHPC; impurity analysis; potency; sterility and pyrogen status

Indexed keywords

BENZYL ALCOHOL; BENZYL BENZOATE; CASTOR OIL; HEXANOIC ACID; HYDROXYPROGESTERONE CAPROATE; PYROGEN;

EID: 84890833559     PISSN: 00029378     EISSN: 10976868     Source Type: Journal    
DOI: 10.1016/j.ajog.2013.09.039     Document Type: Article
Times cited : (10)

References (13)
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    • National Institute of Child Health and Human Development Maternal-Fetal Medicine Units Network: Prevention of recurrent preterm delivery by 17 alpha- hydroxyprogesterone caproate
    • P.J. Meis, M. Klebanoff, and E. Thom et al. National Institute of Child Health and Human Development Maternal-Fetal Medicine Units Network: prevention of recurrent preterm delivery by 17 alpha- hydroxyprogesterone caproate N Engl J Med 348 2003 2379 2385
    • (2003) N Engl J Med , vol.348 , pp. 2379-2385
    • Meis, P.J.1    Klebanoff, M.2    Thom, E.3
  • 2
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    • Food and Drug Administration. FDA statement on Makena, Nov. 8. Accessed Aug. 27, 2013
    • Food and Drug Administration. FDA statement on Makena, Nov. 8, 2011. Available at: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ ucm279098.htm. Accessed Aug. 27, 2013.
    • (2011)
  • 6
    • 84890857365 scopus 로고    scopus 로고
    • Food and Drug Administration. FDA statement on Makena, March 30, Accessed Aug. 27, 2013
    • Food and Drug Administration. FDA statement on Makena, March 30, 2011 Available at: http://www.fda.gov/newsEvents/Newsroom/PressAnnouncements/ ucm249025.htm. Accessed Aug. 27, 2013.
    • (2011)
  • 7
    • 84859353705 scopus 로고    scopus 로고
    • Quality investigation of hydroxyprogesterone caproate active pharmaceutical ingredient and injection
    • J.L. Chollet, and M.J. Jozwiakowski Quality investigation of hydroxyprogesterone caproate active pharmaceutical ingredient and injection Drug Dev Ind Pharm 38 2012 540 549
    • (2012) Drug Dev Ind Pharm , vol.38 , pp. 540-549
    • Chollet, J.L.1    Jozwiakowski, M.J.2
  • 9
    • 84878417474 scopus 로고    scopus 로고
    • Qualitative and quantitative measures of various compounded formulations of 17-alpha hydroxyprogesterone caproate
    • 74-80
    • S.N. Caritis, Y. Zhao, and J. Bettinger et al. Qualitative and quantitative measures of various compounded formulations of 17-alpha hydroxyprogesterone caproate Am J Obstet Gynecol 208 2013 470.e1 470.e5 74-80
    • (2013) Am J Obstet Gynecol , vol.208
    • Caritis, S.N.1    Zhao, Y.2    Bettinger, J.3
  • 10
    • 84890855735 scopus 로고    scopus 로고
    • Eagle Analytical ServicesvRapid Scan RDI-Bacteria, mold, and fungal test. Accessed Aug. 27, 2013
    • Eagle Analytical ServicesvRapid Scan RDI-Bacteria, mold, and fungal test. Available at: http://www.eagleanalytical.com/sitecontent/589/rapid-scan-rdi- bacteria-mold-and-fungal-test/category/462/about-testing.aspx. Accessed Aug. 27, 2013.
  • 11
    • 84890858042 scopus 로고    scopus 로고
    • Eagle Analytical Services. Endotoxins. Accessed August 27, 2013
    • Eagle Analytical Services. Endotoxins. http://www.eagleanalytical.com/ sitecontent/588/endotoxins/category/462/about-testing.aspx. Accessed August 27, 2013.
  • 12
    • 84890859004 scopus 로고    scopus 로고
    • Food and Drug Administration. 17 alpha hydroxyprogesterone caproate injection, NDA 21-9435 Accessed Aug. 27, 2013
    • Food and Drug Administration. 17 alpha hydroxyprogesterone caproate injection, NDA 21-9435. Adeza Biomedical Advisory Committee Meeting, Aug. 9, 2006. Available at: www.fda.gov/ohrms/dockets/ac/06/slides/2006-4227S1-01-01- Adeza.pdf. Accessed Aug. 27, 2013.
    • (2006) Adeza Biomedical Advisory Committee Meeting, Aug. 9
  • 13
    • 84890857361 scopus 로고    scopus 로고
    • American College of Obstetricians and Gynecologists Accessed Aug. 27, 2013
    • American College of Obstetricians and Gynecologists. ACOG/SMFM update on New England compounding center. Available at: http://www.acog.org/About-ACOG/ Announcements/ACOG-SMFM-Update-on-New-England-Compounding-Center. Accessed Aug. 27, 2013.
    • ACOG/SMFM Update on New England Compounding Center


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.