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Category: Microbiological Analysis

Tests available for Microbiological Analysis

USP <61/62> Harmonized Microbial Enumeration and Absence of Specified Organisms USP 61, USP 62

The new harmonized USP <61> describes the microbial enumeration tests.  This portion of the USP outlines new plate count procedures for bacteria, fungi, and yeasts.  Please note that the USP requires that a one-time validation (suitability test) be performed prior to routine testing.

 

The new harmonized USP <62> describes new requirements for growth and recovery of specific organisms which include: Bile-tolerant Gram negative bacteria, Escherichia coli, Salmonella, Staphylococcus aureus, Pseudomonas aeruginosa, Clostridium, Candida albicans.  Please note that the USP requires that a one-time validation (suitability test) be performed prior to routine testing.

 

 

Antimicrobial Preservative Efficacy USP 51, EP, BP, CTFA

USP 81 antibiotic potency assay USP 81

This test is designed to measure the bioactivity or potency of various antibiotic suspensions according to the cylinder plate method described by the United States Pharmacopeia (USP) chapter <81> Antibiotics- Microbial Assays.

Plate Counts USP 61, USP 1227

The standard plate count procedure provides a standardized mean of determining the density of heterotrophic bacteria in samples.  This is an empirical measurement because organisms occur singly, in pairs, clusters, or packets, and no single growth medium or set of physical and chemical conditions can satisfy the physiological requirements of all organisms in a sample.

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