Abstract

Quality Control: Microbial Limit Tests for Nonsterile Pharmaceuticals, Part 2

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

Issue: Jul/Aug 2014 - Volume 18, Number 4

Page(s): 305-310

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Abstract

Cases of contaminated nonsterile products have been reported in increasing numbers. Often, these contaminated products are associated with the presence of objectionable microorganisms. The major contaminants of nonsterile pharmaceutical products and ingredients are bacteria, yeasts, and molds. The combination of parts 1 and 2 of this series of articles provides a thorough examination of microbiological quality testing for nonsterile products.

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