U.S. Pharmacopeial (USP) Convention Methods

The U.S. Pharmacopeial (USP) Convention is a nonprofit that sets standards for the quality of the ingredients in food, medicine, and dietary supplements that are used in the United States and worldwide. The U.S. Food and Drug Administration (FDA) uses the standards set by USP in legislature and actively enforces these standards in the U.S. Meeting the standards set by USP insures the best quality of testing.

At Emery Pharma, we are equipped to test products to ensure compliance with USP standards, in particular the USP testing methods details below.

Antimicrobial Effectiveness Testing (AET), USP <51>

Preservatives are often added to pharmaceuticals, biologics, medical devices, and in vitro diagnostics (IVDs) to prevent microbial growth and ensure the longevity of the product. United States Pharmacopeia <51> (USP <51>), or more commonly known as the Antimicrobial Effectiveness Test (AET), was developed to test the preservative’ effectiveness. Emery Pharma performs AET following the USP <51>, European Pharmacopeia 5.1.3 or Japanese Pharmacopeia 19 methods.

Microbial Examination of Nonsterile Products: Microbial Enumeration Tests, USP <61>

USP <61> test allows for quantitative enumeration of bacteria and fungi that may grow under aerobic conditions on nonsterile products to be determined through the total aerobic microbial count (TAMC) or total combined yeasts and molds count (TYMC). Based on these, the compliance of a substance or preparation with an established specification for microbiological quality can shown.

Microbial Examination of Nonsterile Products: Tests for Specified Microorganisms, USP <62>

Even in small numbers, some microorganisms can be dangerous, so in addition to the numbers calculated in USP <61> test, the USP<62> tests for the presence or absence of specified microorganisms in a product to determine whether a substance or preparation complies with an established specification for microbiological quality.

We are able to provide a full range of services for companies and organization currently in their pre-clinical and clinical stages of R&D. Our scientists provide top-of-the-line laboratory services and have extensive experience in testing of antimicrobial compounds and devices. Other USP tests are available please visit the USP website for more information about the tests and contact us today.