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Bioo Scientific Facilitates the Analysis of Melamine Contamination in Pharmaceutical Ingredients - Bioo Scientific is developing protocols to allow the MaxSignal® Melamine Test Kit to be used to screen for melamine contamination in pharmaceutical ingredients in response to the FDA’s recently released Melamine Contamination Guidance
Bioo Scientific Facilitates the Analysis of Melamine Contamination in Pharmaceutical Ingredients

 

NewswireToday - /newswire/ - Austin, TX, United States, 2009/08/27 - Bioo Scientific is developing protocols to allow the MaxSignal® Melamine Test Kit to be used to screen for melamine contamination in pharmaceutical ingredients in response to the FDA’s recently released Melamine Contamination Guidance.

   
 
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In response to the Melamine Contamination Guidance recently announced by the U.S. Food and Drug Administration (FDA), Bioo Scientific is developing protocols to allow the MaxSignal® Melamine Enzymatic Assay Kit to be used to screen pharmaceutical ingredients for melamine contamination. Earlier this month the FDA announced that certain pharmaceutical ingredients used in the manufacture of drug products should be tested for melamine. Melamine is a dangerous, nitrogen rich organic compound that has been recently found in milk products and pet food. Consumption of melamine causes highly insoluble melamine cyanurate crystals to form in the kidney, which damage renal cells and can result in renal failure or death. While melamine contamination has not been found in pharmaceutical products, the FDA wants to implement controls to assure consumers that melamine contamination of the pharmaceutical supply chain will not occur.

Bioo Scientific’s MaxSignal Melamine Enzymatic Assay Kit allows pharmaceutical companies to quickly and inexpensively screen pharmaceutical ingredients for melamine contamination. The MaxSignal Melamine Enzymatic Assay Kit is a rapid aqueous extraction method that is able to detect down to 0.2 ppm of melamine. According to Dr. Joe Krebs, Director of Protein Chemistry and Engineering at Bioo Scientific, “The robust, specific ability of our unique enzyme reagent to detect melamine in a wide range of chemical matrices makes the Bioo Melamine Enzymatic Assay Kit the ideal choice for rapid, cost-effective detection of melamine adulteration in pharmaceutical components.” Bioo Scientific looks forward to working closely with the pharma industry to address this growing health concern. The MaxSignal® Melamine Enzymatic Assay Kit is a USDA funded project (2008-33610-18948).

About Bioo Scientific

Bioo Scientific Corporation (biooscientific.com) is a global biotechnology tools company, headquartered in Austin, Texas. Bioo Scientific provides innovative products and services to academic researchers, pharmaceutical and biotechnology companies, molecular diagnostics laboratories, and customers who perform food and feed safety analysis.

 
 
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Bioo Scientific Facilitates the Analysis of Melamine Contamination in Pharmaceutical Ingredients

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Publisher Contact: Dawn Obermoeller 
512-301-4094 dawno[.]biooscientific.com
 
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