Dionex has announced two application notes created in support of the official release of the United States Pharmacopeia (USP) stage 2 heparin-sodium monograph, published 1 October, 2009.
Following reports of heparin contamination, including 200 product-related deaths and subsequent heparin recalls, the USP strengthened the heparin monograph by including a new potency assay, new identification tests and additional tests for the presence of impurities.
The identification and organic-impurities tests employ ion chromatography.
Application Note 233, 'Determination of Galactosamine Containing Organic Impurities in Heparin by HPAE-PAD Using the Carbopac PA20 Column', presents detailed background information that will help an analytical chemist perform the updated monograph's Limit of Galactosamine in Total Hexosamine analysis listed under Organic Impurities.
The method utilises a Carbopac PA20 column and pulsed-amperometric detection.
Both analytical precision and method ruggedness are demonstrated.
Application Note 235, 'Determination of Oversulfated Chondroitin Sulfate and Dermatan Sulfate in Heparin Sodium Using Anion-Exchange Chromatography with UV Detection', describes the separation of dermatan sulfate, oversulfated chondroitin sulfate (OSCS) and heparin using a Dionex Ionpac AS11 column and UV-absorbance detection, thereby demonstrating a method for OSCS- contaminated heparin to be detected and quarantined from worldwide supplies.
This method corresponds to the method found in the Chromatographic Identity section of the USP monograph.
