title: Development and qualification of a size exclusion chromatography coupled with multiangle light scattering method for molecular weight determination of unfractionated heparin.
abstract: The molecular weight of unfractionated heparin was determined by size exclusion chromatography (SEC) coupled with multiangle light scattering (MALS) detection. The SEC/MALS method determines absolute molecular weight directly from the angular dependence of scattered light intensity as a function of concentration and does not rely on molecular weight standards for column calibration. The SEC/MALS method developed at Scientific Protein Laboratories was qualified in terms of specificity, precision, robustness, and accuracy. By eliminating the requirement of well-characterized molecular weight standards derived from heparin, the present procedure represents a clear improvement over the column calibration methods used in molecular weight determination. The SEC/MALS method is suitable for routine quality control of unfractionated heparin.
authors.affiliation: Scientific Protein Laboratories LLC, 700 East Main Street, Waunakee, WI 53597, USA.
authors.forename: John
authors.initials: J
authors.lastname: Beirne
authors.forename: Hilary
authors.initials: H
authors.lastname: Truchan
authors.forename: Lin
authors.initials: L
authors.lastname: Rao
mesh_terms: D000925:Anticoagulants / Q000737:chemistry*; D002850:Chromatography, Gel / Q000379:methods*; D004340:Drug Contamination; D006493:Heparin / Q000737:chemistry*; D008027:Light; D008970:Molecular Weight; D012542:Scattering, Radiation; D012680:Sensitivity and Specificity
chemical_list: D000925:Anticoagulants; D006493:Heparin