Heparin is a highly sulfated glycosaminoglycan widely used as an injectable anticoagulant. Pharmaceutical grade heparin is derived from mucosal tissues such as porcine (pig) intestines or bovine (cattle) lungs. In 2009 the USP revised the Heparin monograph , anion Exchange HPLC in combination with Pulsed Amperometric Detection (PAD) is used to determine the organic impurities. The USP acceptance criteria for Heparin is that not more than 1% galactosamine is present relative to the total amount of glucosamine in a hydrolyzed sample solution. The ALEXYS Analyzer for Heparin meets all USP requirements.
For the analysis of GalN and GlcN in Heparin we selected the DECADE Elite with a SenCell electrochemical cell as the EP/USP methods require a stainless steel AUX electrode. The DECADE Elite has a 4-step pulse with less wear of the electrode material, and the SenCell is known for its robusteness and detection sensitivity. The HyREF is maintenance free even at pH 13! The ALEXYS Analyzer comprises the following parts:
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