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Dionex Applications for Securing Purity of Anti-Coagulant Heparin
January 2010, Sunnyvale, CA-Dionex Corp. is pleased to announce the availability of two application notes created in support of the official release of the United States Pharmacopeia (USP) stage 2 heparin sodium monograph, published October 1, 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 and are covered in the following Dionex applications notes:
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 utilizes 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, OSCS, and heparin using a Dionex IonPac® AG11 column and UV absorbance detection, thereby demonstrating a method for OSCS-contaminated heparin to be detected and quarantined from world-wide supplies. This method corresponds to the method found in the Chromatographic Identity section of the USP monograph.
Dionex (NASDAQ:DNEX) is a global leader in the manufacturing and marketing of liquid chromatography and extraction systems, consumables, and software for chemical analysis. The Company's systems are used worldwide in environmental analysis and by the life sciences, chemical, petrochemical, food and beverage, power generation, and electronics industries. Our expertise in applications and instrumentation helps analytical scientists to evaluate and develop pharmaceuticals, establish environmental regulations, and produce better industrial products.
CarboPac and IonPac are registered trademarks of Dionex Corporation.