Patent ID: 8597957
Filing Date: 2013-12-03
Classification: A61K,G01N,G06Q,Y10T

Abstract:
1. A method of evaluating an unfractionated heparin preparation, comprising: providing an unfractionated heparin preparation to determine its suitability for use as a drug or in the preparation of a drug, wherein the unfractionated heparin preparation is suitable for use as a drug or in the preparation of a drug when OSCS is not present or is present below a limit of detection; and analyzing the unfractionated heparin preparation by a SAX-HPLC method, wherein the run time for the SAX-HPLC method is not more than 45 minutes, and wherein the SAX-HPLC method uses a SAX-HPLC column calibrated with a standard; to determine the absence or presence of over sulfated chondrotin sulfate (OSCS), wherein the limit of detection of OSCS in the unfractionated heparin preparation is 0.05% (w/w) or less, the OSCS is resolved from a baseline and the OSCS is resolved from other components of the unfractionated heparin preparation; and making a decision about the unfractionated heparin preparation based upon the analysis, to thereby evaluate the unfractionated heparin preparation.