Comparison of Compendial Antimicrobial Effectiveness Tests: A Review
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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 wordsantimicrobial effectiveness pharmacopeia preservative effectiveness
We thank Anthony Cundell for a critically reviewing this manuscript.
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