Bioo Scientific has announced it will be developing protocols for its MaxSignal melamine test kit to screen pharmaceutical ingredients for melamine contamination in response to recent melamine scares in the US.
Earlier in August the US Food and Drug Administration released Melamine Contamination Guidance announcing that certain pharmaceutical ingredients used in the manufacture of drug products should be tested for melamine.
Melamine, which has been recently found in milk and pet products, causes highly insoluble melamine cyanurate crystals to form in the kidney, which damage renal cells and can result in renal failure or death.
Bioo Scientifics’ MaxSignal Melamine Enzymatic Assay Kit uses a rapid aqueous extraction method to detect melamine levels down to 0.2ppm.
Bioo scientific director of protein chemistry and engineering Dr Joe Krebs said that the kit is the ideal choice for rapid, cost-effective detection of melamine adulteration in pharmaceutical components.
“The robust, specific ability of our unique enzyme reagent to detect melamine in a wide range of chemical matrices makes this product an ideal choice,” Krebs said.
The MaxSignal Melamine Enzymatic Assay Kit is a USDA-funded project.