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Quality Control Analytical Methods: The Essentials of United States Pharmacopeia Chapter <51> Antimicrobial Effectiveness Testing and Its Application in Pharmaceutical Compounding

Author(s):  Vu Nicole, Nguyen Devin, Kupiec Thomas C

Issue:  Mar/Apr 2014 - Volume 18, Number 2
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Abstract:  Antimicrobial preservatives are excipients added to multi-dose containers of both sterile and non-sterile drug products. Antimicrobial preservatives are used primarily to inhibit growth of microbial contamination occurring during the period of use. Demonstration of antimicrobial preservative effectiveness is required for these functional excipients. This article reviews key factors for consideration in the selection of preservatives, principles of the preservative-effectiveness test, and the significance of requirements for preservative-effectiveness testing in the compounding practice.

Related Keywords: Nicole Vu, PhD, Kevin Nguyen, Thomas C. Kupiec, PhD, United States Pharmacopeia Chapter <51>, USP, antimicrobial effectiveness testing, drug contamination, antimicrobial preservatives, compounded sterile preparations, microbial growth, multi-dose containers, test organisms, challenge test, method suitability test, acceptance criteria

Related Categories: EXCIPIENTS, STERILE PREPARATIONS, QUALITY CONTROL, UNITED STATES PHARMACOPEIA CONVENTIONS, DOSAGE FORMS/DRUG CARRIERS, INFECTIOUS DISEASE

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