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Does USP consider dermatan sulfate to be a contaminant and should it be addressed in Stage 1 revision?

April 26, 2017addressed contaminant revision Stage Sulfate USP

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Does USP consider dermatan sulfate to be a contaminant and should it be addressed in Stage 1 revision?

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USP considers dermatan sulfate to be a process impurity that is present in heparin. Lower levels of dermatan sulfate indicate a better impurity removal process, but dermatan sulfate has not been linked to the deaths and injuries caused by adulterated heparin. Limits and test methods for dermatan sulfate will be addressed in the Stage 2 revision.