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Quality Control Analytical Methods: Microbial Limit Tests for Nonsterile Pharmaceuticals, Part 1

Author(s):  Vu Nicole,Lou Jessica R,Kupiec Thomas

Issue:  May/Jun 2014 - Volume 18, Number 3
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Abstract:  Contamination of pharmaceuticals with microorganisms may lead to deleterious effects on the therapeutic properties of the drug, and may potentially cause injuries to intended recipients. Cases of contaminated nonsterile products have been reported in increasing numbers, and often associated with the presence of objectionable microorganisms. Methods for detection of these organisms are described in three major Pharmacopeias. Their functions and their limitations in the examination of microbiological quality for nonsterile products will be reviewed in this report.

Related Keywords: Nicole Vu, PhD, Jessica R. Lou, BS, Thomas C. Kupiec, PhD, microbial limit tests, bacterial contamination, nonsterile compounds, microorganisms, antimicrobial preservatives, USP, United States Pharmacopeia Chapter <61>, United States Pharmacopeia Chapter <62>, United States Pharmacopeia Chapter <1111>, yeasts, molds, fungi, microbes, microbial ennumeration tests, acceptance criteria, microbiological quality control, method suitability tessting, test sample preparation

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

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