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FDA working on pattern recognition model that could ID other heparin contaminants

This article was originally published in The Gold Sheet

Executive Summary

FDA's Division of Pharmaceutical Analysis is seeking contract support to develop a multivariate mathematical model that could tell whether heparin samples contain low levels of dermatan sulfate, a common impurity, oversulfated chondroitin sulfate, an economically motivated adulterant, or other oversulfated glucosaminoglycans that the division prepares or purchases. There has been speculation that the miscreants who contaminated heparin API with OSCS might try to do it with other substances. The FDA study will use heparin nuclear magnetic resonance imaging spectra from more than 150 heparin API samples tainted with varying levels of OSCS and dermatan sulfate, plus other sample data to "determine if pattern recognition models are capable of discriminating low levels of OSCS and other contaminants in heparin sodium," FDA said

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