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AAPS PharmSciTech

, Volume 12, Issue 1, pp 222–226 | Cite as

Comparison of Compendial Antimicrobial Effectiveness Tests: A Review

  • Cheryl L. Moser
  • Brian K. MeyerEmail author
Review Article Theme: Sterile Products: Advances and Challenges in Formulation, Manufacturing, Devices and Regulatory Aspects

Abstract

The antimicrobial effectiveness or preservative effectiveness test is described in the tripartite compendia for sterile parenteral multi-dose formulated products. The execution of the test is essentially harmonized with respect to inoculum preparation and test execution but not the acceptance criteria. This article describes how a single test can be performed that procedurally satisfies all of the compendia and their acceptance criteria.

Key words

antimicrobial effectiveness pharmacopeia preservative effectiveness 

Notes

Acknowledgments

We thank Anthony Cundell for a critically reviewing this manuscript.

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Copyright information

© American Association of Pharmaceutical Scientists 2011

Authors and Affiliations

  1. 1.Merck & Co.West PointUSA

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