Determination of Galactosamine Containing Organic Impurities in Heparin Using a Compact Ion Chromatography System

Instrument Type: IC

This record shows that AN233 can be run using an Integrion ion chromatography system. In AN233, the organic impurities in heparin are determined by HPAE-PAD using the Dionex CarboPac PA20 column following the USP monograph method. This method provides sensitive determination of galactosamine in acid-hydrolyzed heparin samples, enabling the identification of heparin that has been contaminated with chondroitin sulfates.

AN235: Determination of Oversulfated Chondroitin Sulfate and Dermatan Sulfate in Heparin Sodium Using Anion-Exchange Chromatography with UV Detection

Instrument Type: IC

Heparin, a complex sulfated glycosaminoglycan, is a well-known anticoagulant used to stop or prevent blood from clotting in certain types of surgeries and dialysis treatments. In 2008, a galactosamine-based synthetic contaminant, called Oversulfated Chondrotin Sulfate (OSCS), was identified in Heparin as causing severe adverse affects and in some, death. The current USP 32 monograph from 2008 was upgraded to include chromatographic methods to detect OSCS and the natural contaminant, dermatan sulfate (DS). In this method, heparin, DS, and OSCS were separated by IC and detected at 202 nm.