Dunwoody Pharmacy Testing Results

Dermatology Associates of Atlanta

www.eagleanalytical.com

Dunwoody Pharmacy is devoted to making sure that the compounds that we make are held to the highest standard possible. That is the reason that we have random testing done to ensure that these products are correct, sterile, and free from endotoxins. We feel that this information needs to be transparent to our patients, providers, and general public to know that our products are what we say they are!

Below, you will find our test results from Eagle Analytical, this is an independant company that tests our products. We have provided a link to their website as well.

What we test for

Bacterial Endotoxins

Endotoxins are defined as cell wall material from gram-negative bacteria. Upon injection, endotoxins may cause a state of shock, fever, altered resistance to bacterial infection, as well as other biologic effects. Endotoxins are part of a larger group known as pyrogens. Pyrogens are fever-inducing agents produced by bacteria, molds, viruses, and yeasts.

Sterility USP <71>

USP <71> fourteen (14)-day membrane filtration sterility test procedure. Tests for BACTERIA, MOLD, YEAST and FUNGI with two media at two separate temperatures. Test read on days 3, 7 and 14

Rapid Scan RDI Microbial Detection

Rapid Scan RDI Microbial Detection Test (filterable samples only). Rapid microbiological test with direct cell count, down to a single microbial cell, without the need for cell growth. Procedure utilizes fluorescent labeling and laser scanning technologies for the detection of bacteria, mold, yeast, and fungi. Results usually available within 48 hours after receipt of sample

The Scan RDI is an automated system that directly distinguishes individual cells without requiring a time-consuming growth stage. It utilizes a four-step protocol. The first step is membrane filtration through a 25mm membrane. The second step includes cell labeling with a fluorescent dye. During the third step, the membrane is placed in the Scan RDI instrument and is scanned with a laser. Within three minutes, all viable microorganisms are detected and counted. The fourth step is visual confirmation of the microorganisms with a fluorescent microscope.

A pass as a result means that the product has a direct count of bacteria, molds, and fungi down to one colony-forming unit.

The standard deviation for compounded products is + or – 10%, if you notice at the bottom of the reports it list what USP <795> states about compounded medications. That compounded preparations are to be prepared to ensure that each preparation shall conain not less than 90%, and not more than 110% of the active ingredients.

What is USP?

The U.S. Pharmacopeial Convention (USP) is a scientific nonprofit organization that sets standards for the identity, strength, quality, and purity of medicines, food ingredients, and dietary supplements manufactured, distributed and consumed worldwide. USP’s drug standards are enforceable in the United States by the Food and Drug Administration, and these standards are developed and relied upon in more than 140 countries.

Sterile

Non-Sterile

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