title: Monitoring the purity of pharmaceutical heparin preparations by high-field 1H-nuclear magnetic resonance spectroscopy.
abstract: High-field (300 MHz) 1H NMR spectral analyses are reported for various sodium or calcium heparin products available on the Canadian market. Dermatan sulfate (chondroitin sulfate B) was detected as a contaminant in virtually all of these products. Its content varied among the suppliers from less than 1 to 15%, and also over nearly the same range within the groups of heparin preparations of particular suppliers. No correlation was found between in vitro biological activities (potency and anti-factor Xa by the USP tests) and the levels of dermatan sulfate found. Other components, or unlisted constituents, detected in some preparations were paramagnetic metal ions, polyols, and lidocaine.
authors.affiliation: Bureau of Drug Research, Health and Welfare Canada, Ottawa, ON.
authors.forename: G A
authors.initials: GA
authors.lastname: Neville
authors.forename: F
authors.initials: F
authors.lastname: Mori
authors.forename: K R
authors.initials: KR
authors.lastname: Holme
authors.forename: A S
authors.initials: AS
authors.lastname: Perlin
mesh_terms: D055598:Chemical Phenomena; D002621:Chemistry; D003871:Dermatan Sulfate / Q000032:analysis; D004492:Edetic Acid / Q000032:analysis; D015951:Factor Xa; D006493:Heparin / Q000302:isolation & purification* / Q000494:pharmacology; D006495:Heparin, Low-Molecular-Weight / Q000032:analysis / Q000494:pharmacology; D007413:Intestinal Mucosa / Q000032:analysis; D009682:Magnetic Resonance Spectroscopy; D015842:Serine Proteinase Inhibitors
chemical_list: D006495:Heparin, Low-Molecular-Weight; D015842:Serine Proteinase Inhibitors; D003871:Dermatan Sulfate; D006493:Heparin; D004492:Edetic Acid; D015951:Factor Xa