Pharmaceutisch weekblad

, Volume 3, Issue 1, pp 245–251 | Cite as

Challenge testing — The laboratory evaluation of the preservation of pharmaceutical preparations

  • D. F. Spooner
  • B. Croshaw


The need for adequate preservation and the difficulties of definition and testing are outlined and pharmacopoeial challenge tests are compared. While similar in principle they differ in detail and in the interpretation of results. The USP test is intended for multi-dose sterile products but BP and draft EP tests include also criteria for topical and liquid oral preparations. Those of the BP, based on the performance of established well-preserved BP preparations, are not mandatory but provide guidance for the selection of suitable antimicrobial preservatives for inclusion in formulae of the Pharmacopoeia.


Challenge Test Sodium Cromoglycate United States Pharmacopeia British Pharmacopoeia Cosmetic Chemist 
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  1. Ahearn, D.G., J. Sanghvi andG. J. Haller (1978)J. Soc. Cosmetic Chemists 29, 127–131.Google Scholar
  2. Al-Hiti, M. M. A., andP. Gilbert (1980)J. Appl. Bacteriol. 49, 119–126.CrossRefPubMedGoogle Scholar
  3. Baird, R. M., C. A. Crowden, G. M. O'Farrel andR. A. Shooter (1979)J. Hyg. Camb. 83, 277–283.CrossRefPubMedPubMedCentralGoogle Scholar
  4. Baker, J. H. (1959)J. Soc. Cosmetic Chemists 10, 133–142.Google Scholar
  5. Barr, M., andL. F. Tice (1957)J. Am. Pharm. Assoc. Sci. Ed. 46, 445–451.CrossRefGoogle Scholar
  6. Bean, H. S. (1972)J. Soc. Cosmetic Chemists 23, 703–720.Google Scholar
  7. British Pharmacopoeia (1973) 242;Ibidem (1980) 11, A192-A194.Google Scholar
  8. Bruch, C. W. (1972)Drug Cosmetic Ind. 110, 32–37.Google Scholar
  9. Croshaw, B. (1977)J. Soc. Cosmetic Chemists 28, 3–16.Google Scholar
  10. Moore, K. E. (1978)J. Appl. Bacteriol. 44, SXliii-Slv.CrossRefPubMedGoogle Scholar
  11. Morse, L. J., H. L. Williams, F. P. Green, E. E. Eldridge andJ. R. Rotta (1967)New Engl. J. Med. 277, 472–473.CrossRefPubMedGoogle Scholar
  12. Report (1980)Pharm. Acta. Helv. 55, 40,49.Google Scholar
  13. Smart, R., andD. F. Spooner (1972)J. Soc. Cosmetic Chemists 23, 721–734.Google Scholar
  14. Spooner, D. F., andG. Sykes (1972)Methods in Microbiology, 7B. Academic Press, London, 211–276.Google Scholar
  15. United States Pharmacopeia (1970) XVIII, 845-846;Ibidem (1975) XIX, 587–588;Ibidem (1980) XX, 873–874.Google Scholar
  16. Yablonski, J. I. (1972)Bull. Parenteral Drug Assoc. 26, 220–225.Google Scholar

Copyright information

© Bohn, Scheltema & Holkema 1981

Authors and Affiliations

  • D. F. Spooner
    • 1
  • B. Croshaw
    • 1
  1. 1.The Boots Company Ltd.NottinghamEngland

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