Examination of Nonsterile
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چکیده
EXAMINATION OF NONSTERILE Preparation of Test Strains PRODUCTS: MICROBIAL Use standardized stable suspensions of test strains or prepare as stated below. Seed-lot culture maintenance techENUMERATION TESTS niques (seed-lot systems) are used so that the viable microorganisms used for inoculation are not more than five passages removed from the original master seed-lot. Grow each of the bacterial and fungal test strains separately as described in Table
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Quality Control: microbial limit tests for nonsterile pharmaceuticals, part 2.
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 microbi...
متن کاملQuality control analytical methods: microbial limit tests for nonsterile pharmaceuticals, Part 1.
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...
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