In 2007, heparin contaminated with oversulfated chondroitin sulfate (OSCS) caused severe anaphylactic reactions in some patients. This contaminant was not detected by the existing USP 31 monograph. Therefore, the USP added an Identification B method to the stage 2 revision of USP 32 to separate heparin from the contaminant OSCS and dermatan sulfate (DS) impurity. However, DS was not well resolved from heparin and the analysis times were 75 min. In this presentation, we demonstrate an improved method by using a high-capacity L61 anion-exchange column with a salt gradient and tris buffer to detect 1% DS and OSCS in heparin at 215 nm. This method provides increased resolution between DS and heparin, increased peak efficiency of heparin, and increased sample throughput by reducing the analysis time to 40 min. In addition, this method has the advantage of using an environmentally safe mobile phase without any added health concerns.

Determination of heparin contaminants and impurities by anion exchange chromatography

241st National Meeting (2011)

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