Microbiological Contamination Limits In Pharmaceutical Preparations

Ideally all pharmaceutical preparations would be completely free from any form of contamination, including microbiological contamination. However, this is not truly necessary and is impractical for most preparations. This is recognised by the pharmacopoeias. Both the United States Pharmacopeia (USP) and the European Pharmacopoeia (PhEur) contain chapters describing testing of pharmaceutical preparations for compliance with microbiological contamination limits. The USP specifies mandatory microbiological limits within most of its guides for pharmaceutical preparations. PhEur specifies nonmandatory microbiological limits for general categories of pharmaceutical preparations.

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