- adj. Overly sulfated.
“Chinese officials have disputed the FDA's finding that the contaminant was a substance called oversulfated chondroitin sulfate.”
“An FDA task force that included drug-industry researchers said the adulterant was oversulfated chondroitin sulfate, a substance that increases the potency of heparin and makes it more valuable.”
“Baxter tests on the Delaware incidents didn't detect a contaminant found in last year's heparin-illness outbreak, oversulfated chondroitin sulfate.”
“But both the U.S. and Chinese drug agencies said they were investigating how the oversulfated chondroitin sulfate, which does not occur naturally, got into the heparin batches.”
“Earlier this week, the U.S. Food and Drug Administration identified the contaminant in heparin batches from a Chinese supplier to U.S. pharmaceuticals company Baxter International Inc. as oversulfated chondroitin sulfate.”
“The FDA has said it doesn't yet know how or when the contaminated ingredient, oversulfated chondroitin sulfate, was put into the supply.”
“The contaminant – oversulfated-chondroitin sulfate – is much more plentiful in the animal, but isn't approved for medical use because it can cause severe allergic reactions in humans.”
“Last month, the FDA said some of the heparin contained oversulfated chondroitin sulfate, an altered version of chondroitin sulfate that is used as a dietary supplement and is typically made from animal cartilage.”
“We presume it is the same contaminant," oversulfated chondroitin sulfate, as found in batches of heparin in the U.S., "but it has yet to be definitively confirmed," he said.”
“According to the guidance document, contamination involving the chemical at issue -- oversulfated chondroitin sulfate OSCS -- appears intentional to save costs.”
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