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Volumn 399, Issue 2, 2011, Pages 581-591

Characterization of currently marketed heparin products: Key tests for quality assurance

Author keywords

CE; Factor IIa Xa; Heparin; NMR; OSCS; SAX HPLC

Indexed keywords

CE; FACTOR IIA/XA; HEPARIN; NMR; OSCS; SAX-HPLC;

EID: 79251634435     PISSN: 16182642     EISSN: 16182650     Source Type: Journal    
DOI: 10.1007/s00216-010-4023-y     Document Type: Article
Times cited : (38)

References (34)
  • 1
    • 61449171129 scopus 로고    scopus 로고
    • Lessons learned from the contamination of heparin
    • 1:CAS:528:DC%2BD1MXisVGjsL8%3D 10.1039/b819896a
    • H Liu Z Zhang RJ Linhardt 2009 Lessons learned from the contamination of heparin Nat Prod Rep 26 313 321 1:CAS:528:DC%2BD1MXisVGjsL8%3D 10.1039/b819896a
    • (2009) Nat Prod Rep , vol.26 , pp. 313-321
    • Liu, H.1    Zhang, Z.2    Linhardt, R.J.3
  • 2
    • 0035984272 scopus 로고    scopus 로고
    • Heparin and heparan sulfate: Structure and function
    • 1:CAS:528:DC%2BD38XlsFSnsbY%3D 10.1039/b100916h
    • DL Rabenstein 2002 Heparin and heparan sulfate: structure and function Nat Prod Rep 19 312 331 1:CAS:528:DC%2BD38XlsFSnsbY%3D 10.1039/b100916h
    • (2002) Nat Prod Rep , vol.19 , pp. 312-331
    • Rabenstein, D.L.1
  • 3
    • 34047203810 scopus 로고    scopus 로고
    • Essentials of anticoagulation in hemodialysis
    • 10.1111/j.1542-4758.2007.00166.x
    • KG Fischer 2007 Essentials of anticoagulation in hemodialysis Hemodial Int 11 178 189 10.1111/j.1542-4758.2007.00166.x
    • (2007) Hemodial Int , vol.11 , pp. 178-189
    • Fischer, K.G.1
  • 4
    • 34848894556 scopus 로고    scopus 로고
    • Anticoagulation for acute coronary syndromes: From heparin to direct thrombin inhibitors
    • NE Lepor 2007 Anticoagulation for acute coronary syndromes: from heparin to direct thrombin inhibitors Rev Cardiovasc Med 8 Suppl 3 S9 S17
    • (2007) Rev Cardiovasc Med , vol.8 , Issue.SUPPL 3
    • Lepor, N.E.1
  • 5
    • 77950867423 scopus 로고    scopus 로고
    • Assay of possible economically motivated additives or native impurities levels in heparin by 1H NMR, SAX-HPLC, and anticoagulation time approaches
    • 1:CAS:528:DC%2BC3cXksVamsrs%3D 10.1016/j.jpba.2010.02.019
    • DA Keire DJ Mans H Ye RE Kolinski LF Buhse 2010 Assay of possible economically motivated additives or native impurities levels in heparin by 1H NMR, SAX-HPLC, and anticoagulation time approaches J Pharm Biomed Anal 52 656 664 1:CAS:528:DC%2BC3cXksVamsrs%3D 10.1016/j.jpba.2010.02.019
    • (2010) J Pharm Biomed Anal , vol.52 , pp. 656-664
    • Keire, D.A.1    Mans, D.J.2    Ye, H.3    Kolinski, R.E.4    Buhse, L.F.5
  • 6
    • 79251625033 scopus 로고    scopus 로고
    • USP (Ed.)^(Eds.), United States Pharmacopeia National Formulary 31 NF 26, Rand McNally, Rockville, MD (May 1)
    • USP (2008) In: Heparin Sodium. (Ed.)^(Eds.), United States Pharmacopeia National Formulary 31 NF 26, Rand McNally, Rockville, MD, pp. 2321-2322 (May 1)
    • (2008) Heparin Sodium , pp. 2321-2322
  • 7
    • 38949094248 scopus 로고    scopus 로고
    • Acute allergic-type reactions among patients undergoing hemodialysis-multiple states
    • WHO
    • WHO 2008 Acute allergic-type reactions among patients undergoing hemodialysis-multiple states MMWR Morb Mortal Wkly Rep 57 124 125
    • (2008) MMWR Morb Mortal Wkly Rep , vol.57 , pp. 124-125
  • 8
    • 44949233239 scopus 로고    scopus 로고
    • The FDA and safety-beyond the heparin crisis
    • 1:CAS:528:DC%2BD1cXmvVCjtrg%3D 10.1038/nbt0608-621
    • CT Laurencin L Nair 2008 The FDA and safety-beyond the heparin crisis Nat Biotechnol 26 621 623 1:CAS:528:DC%2BD1cXmvVCjtrg%3D 10.1038/nbt0608-621
    • (2008) Nat Biotechnol , vol.26 , pp. 621-623
    • Laurencin, C.T.1    Nair, L.2
  • 9
    • 78649339727 scopus 로고    scopus 로고
    • U.S. Department of Health and Human Services USFDA (November 2009) Information on adverse event reports and heparin. http://www.fda.gov/Drugs/ DrugSafety/PostmarketDrugSafetyInformationforPateintsandProviders/UCM112669
    • (2009) Information on Adverse Event Reports and Heparin
  • 12
    • 77953063429 scopus 로고    scopus 로고
    • Bradykinin forming capacity of oversulfated chondroitin sulfate contaminated heparin in vitro
    • 1:CAS:528:DC%2BC3cXmtlKitrc%3D 10.1016/j.biomaterials.2010.03.074
    • A Adam N Montpas D Keire A Desormeaux NJ Brown F Marceau B Westenberger 2010 Bradykinin forming capacity of oversulfated chondroitin sulfate contaminated heparin in vitro Biomaterials 31 5741 5748 1:CAS:528: DC%2BC3cXmtlKitrc%3D 10.1016/j.biomaterials.2010.03.074
    • (2010) Biomaterials , vol.31 , pp. 5741-5748
    • Adam, A.1    Montpas, N.2    Keire, D.3    Desormeaux, A.4    Brown, N.J.5    Marceau, F.6    Westenberger, B.7
  • 13
    • 66949114594 scopus 로고    scopus 로고
    • Heparin-induced anaphylactic and anaphylactoid reactions: Two distinct but overlapping syndromes
    • 1:CAS:528:DC%2BD1MXjsVOhsrs%3D 10.1517/14740330902778180
    • TE Warkentin A Greinacher 2009 Heparin-induced anaphylactic and anaphylactoid reactions: two distinct but overlapping syndromes Expert Opin Drug Saf 8 129 144 1:CAS:528:DC%2BD1MXjsVOhsrs%3D 10.1517/14740330902778180
    • (2009) Expert Opin Drug Saf , vol.8 , pp. 129-144
    • Warkentin, T.E.1    Greinacher, A.2
  • 14
    • 0024539192 scopus 로고
    • 1H-nuclear magnetic resonance spectroscopy
    • 1:CAS:528:DyaL1MXht1WmsLs%3D 10.1002/jps.2600780205
    • 1H-nuclear magnetic resonance spectroscopy J Pharm Sci 78 101 104 1:CAS:528:DyaL1MXht1WmsLs%3D 10.1002/jps.2600780205
    • (1989) J Pharm Sci , vol.78 , pp. 101-104
    • Neville, G.A.1    Mori, F.2    Holme, K.R.3    Perlin, A.S.4
  • 15
    • 0023740806 scopus 로고
    • Mapping and quantification of the major oligosaccharide components of heparin
    • 1:CAS:528:DyaL1cXlvVKktLY%3D
    • RJ Linhardt KG Rice YS Kim DL Lohse HM Wang D Loganathan 1988 Mapping and quantification of the major oligosaccharide components of heparin Biochem J 254 781 787 1:CAS:528:DyaL1cXlvVKktLY%3D
    • (1988) Biochem J , vol.254 , pp. 781-787
    • Linhardt, R.J.1    Rice, K.G.2    Kim, Y.S.3    Lohse, D.L.4    Wang, H.M.5    Loganathan, D.6
  • 17
    • 72149085705 scopus 로고    scopus 로고
    • Analysis of crude heparin by (1)H NMR, capillary electrophoresis, and strong-anion-exchange-HPLC for contamination by over sulfated chondroitin sulfate
    • 1:CAS:528:DC%2BD1MXhs1WgsbfF 10.1016/j.jpba.2009.10.017
    • DA Keire ML Trehy JC Reepmeyer RE Kolinski W Ye J Dunn BJ Westenberger LF Buhse 2010 Analysis of crude heparin by (1)H NMR, capillary electrophoresis, and strong-anion-exchange-HPLC for contamination by over sulfated chondroitin sulfate J Pharm Biomed Anal 51 921 926 1:CAS:528:DC%2BD1MXhs1WgsbfF 10.1016/j.jpba.2009.10.017
    • (2010) J Pharm Biomed Anal , vol.51 , pp. 921-926
    • Keire, D.A.1    Trehy, M.L.2    Reepmeyer, J.C.3    Kolinski, R.E.4    Ye, W.5    Dunn, J.6    Westenberger, B.J.7    Buhse, L.F.8
  • 20
    • 0033650826 scopus 로고    scopus 로고
    • Conformation and dynamics of heparin and heparan sulfate
    • 1:CAS:528:DC%2BD3cXosVOjtb0%3D 10.1093/glycob/10.11.1147
    • B Mulloy MJ Forster 2000 Conformation and dynamics of heparin and heparan sulfate Glycobiology 10 1147 1156 1:CAS:528:DC%2BD3cXosVOjtb0%3D 10.1093/glycob/10.11.1147
    • (2000) Glycobiology , vol.10 , pp. 1147-1156
    • Mulloy, B.1    Forster, M.J.2
  • 21
    • 0027164634 scopus 로고
    • NMR and molecular-modeling studies of the solution conformation of heparin
    • 1:CAS:528:DyaK3sXltlWhtL4%3D
    • B Mulloy MJ Forster C Jones DB Davies 1993 NMR and molecular-modeling studies of the solution conformation of heparin Biochem J 293 Pt 3 849 858 1:CAS:528:DyaK3sXltlWhtL4%3D
    • (1993) Biochem J , vol.293 , Issue.PART 3 , pp. 849-858
    • Mulloy, B.1    Forster, M.J.2    Jones, C.3    Davies, D.B.4
  • 23
    • 0031799877 scopus 로고    scopus 로고
    • Conformational changes and anticoagulant activity of chondroitin sulfate following its O-sulfonation
    • 1:CAS:528:DyaK1cXksFCit78%3D 10.1016/S0008-6215(97)10060-X
    • T Maruyama T Toida T Imanari G Yu RJ Linhardt 1998 Conformational changes and anticoagulant activity of chondroitin sulfate following its O-sulfonation Carbohydr Res 306 35 43 1:CAS:528:DyaK1cXksFCit78%3D 10.1016/S0008-6215(97) 10060-X
    • (1998) Carbohydr Res , vol.306 , pp. 35-43
    • Maruyama, T.1    Toida, T.2    Imanari, T.3    Yu, G.4    Linhardt, R.J.5
  • 24
    • 0032725959 scopus 로고    scopus 로고
    • Preparation and anticoagulant activity of fully O-sulphonated glycosaminoglycans
    • 1:CAS:528:DyaK1MXmvVyhurw%3D 10.1016/S0141-8130(99)00088-4
    • T Toida T Maruyama Y Ogita A Suzuki H Toyoda T Imanari RJ Linhardt 1999 Preparation and anticoagulant activity of fully O-sulphonated glycosaminoglycans Int J Biol Macromol 26 233 241 1:CAS:528:DyaK1MXmvVyhurw%3D 10.1016/S0141-8130(99)00088-4
    • (1999) Int J Biol Macromol , vol.26 , pp. 233-241
    • Toida, T.1    Maruyama, T.2    Ogita, Y.3    Suzuki, A.4    Toyoda, H.5    Imanari, T.6    Linhardt, R.J.7
  • 25
    • 61449242663 scopus 로고    scopus 로고
    • Analysis of heparin sodium by SAX/HPLC for contaminants and impurities
    • 1:CAS:528:DC%2BD1MXivVGjtr8%3D 10.1016/j.jpba.2008.12.013
    • ML Trehy JC Reepmeyer RE Kolinski BJ Westenberger LF Buhse 2009 Analysis of heparin sodium by SAX/HPLC for contaminants and impurities J Pharm Biomed Anal 49 670 673 1:CAS:528:DC%2BD1MXivVGjtr8%3D 10.1016/j.jpba.2008.12.013
    • (2009) J Pharm Biomed Anal , vol.49 , pp. 670-673
    • Trehy, M.L.1    Reepmeyer, J.C.2    Kolinski, R.E.3    Westenberger, B.J.4    Buhse, L.F.5
  • 26
    • 64549148990 scopus 로고    scopus 로고
    • Determination of oversulphated chondroitin sulphate and dermatan sulphate in unfractionated heparin by (1)H-NMR-collaborative study for quantification and analytical determination of LoD
    • 1:STN:280:DC%2BD1M7lt1Cgsg%3D%3D
    • I McEwen B Mulloy E Hellwig L Kozerski T Beyer U Holzgrabe R Wanko JM Spieser A Rodomonte 2008 Determination of oversulphated chondroitin sulphate and dermatan sulphate in unfractionated heparin by (1)H-NMR-collaborative study for quantification and analytical determination of LoD Pharmeur Bio 2008 31 39 1:STN:280:DC%2BD1M7lt1Cgsg%3D%3D
    • (2008) Pharmeur Bio , vol.2008 , pp. 31-39
    • McEwen, I.1    Mulloy, B.2    Hellwig, E.3    Kozerski, L.4    Beyer, T.5    Holzgrabe, U.6    Wanko, R.7    Spieser, J.M.8    Rodomonte, A.9
  • 27
    • 77749298749 scopus 로고    scopus 로고
    • Oversulfated chondroitin sulfate is not the sole contaminant in heparin
    • 1:CAS:528:DC%2BC3cXivV2rsbc%3D 10.1038/nbt0310-203 author reply 207-211
    • J Pan Y Qian X Zhou A Pazandak SB Frazier P Weiser H Lu L Zhang 2010 Oversulfated chondroitin sulfate is not the sole contaminant in heparin Nat Biotechnol 28 203 207 1:CAS:528:DC%2BC3cXivV2rsbc%3D 10.1038/nbt0310-203 author reply 207-211
    • (2010) Nat Biotechnol , vol.28 , pp. 203-207
    • Pan, J.1    Qian, Y.2    Zhou, X.3    Pazandak, A.4    Frazier, S.B.5    Weiser, P.6    Lu, H.7    Zhang, L.8
  • 29
    • 0022469330 scopus 로고
    • The haemorrhagic and antithrombotic effects of dermatan sulphate
    • 1:CAS:528:DyaL2sXktFw%3D 10.1111/j.1365-2141.1986.tb04124.x
    • F Fernandez J Van Ryn FA Ofosu J Hirsh MR Buchanan 1986 The haemorrhagic and antithrombotic effects of dermatan sulphate Br J Haematol 64 309 317 1:CAS:528:DyaL2sXktFw%3D 10.1111/j.1365-2141.1986.tb04124.x
    • (1986) Br J Haematol , vol.64 , pp. 309-317
    • Fernandez, F.1    Van Ryn, J.2    Ofosu, F.A.3    Hirsh, J.4    Buchanan, M.R.5
  • 30
    • 0020572581 scopus 로고
    • Angiogenesis inhibition and tumor regression caused by heparin or a heparin fragment in the presence of cortisone
    • 1:CAS:528:DyaL3sXltFGlu70%3D 10.1126/science.6192498
    • J Folkman R Langer RJ Linhardt C Haudenschild S Taylor 1983 Angiogenesis inhibition and tumor regression caused by heparin or a heparin fragment in the presence of cortisone Science 221 719 725 1:CAS:528:DyaL3sXltFGlu70%3D 10.1126/science.6192498
    • (1983) Science , vol.221 , pp. 719-725
    • Folkman, J.1    Langer, R.2    Linhardt, R.J.3    Haudenschild, C.4    Taylor, S.5
  • 31
    • 0023620807 scopus 로고
    • Experimental studies on the relative efficacy of dermatan sulphate and heparin as antithrombotic agents
    • 1:CAS:528:DyaL1cXkvFSguw%3D%3D
    • RE Merton DP Thomas 1987 Experimental studies on the relative efficacy of dermatan sulphate and heparin as antithrombotic agents Thromb Haemost 58 839 842 1:CAS:528:DyaL1cXkvFSguw%3D%3D
    • (1987) Thromb Haemost , vol.58 , pp. 839-842
    • Merton, R.E.1    Thomas, D.P.2
  • 32
    • 11844269975 scopus 로고    scopus 로고
    • Complex glycosaminoglycans: Profiling substitution patterns by two-dimensional nuclear magnetic resonance spectroscopy
    • 1:CAS:528:DC%2BD2MXksVCgtg%3D%3D 10.1016/j.ab.2004.10.012
    • M Guerrini A Naggi S Guglieri R Santarsiero G Torri 2005 Complex glycosaminoglycans: profiling substitution patterns by two-dimensional nuclear magnetic resonance spectroscopy Anal Biochem 337 35 47 1:CAS:528: DC%2BD2MXksVCgtg%3D%3D 10.1016/j.ab.2004.10.012
    • (2005) Anal Biochem , vol.337 , pp. 35-47
    • Guerrini, M.1    Naggi, A.2    Guglieri, S.3    Santarsiero, R.4    Torri, G.5
  • 33
    • 33947407183 scopus 로고    scopus 로고
    • Quantitative determination of disaccharide content in digested unfragmented heparin and low molecular weight heparin by direct-infusion electrospray mass spectrometry
    • 1:CAS:528:DC%2BD2sXjsVGgt7k%3D 10.1016/j.jpba.2007.01.006
    • JE Camara MB Satterfield BC Nelson 2007 Quantitative determination of disaccharide content in digested unfragmented heparin and low molecular weight heparin by direct-infusion electrospray mass spectrometry J Pharm Biomed Anal 43 1706 1714 1:CAS:528:DC%2BD2sXjsVGgt7k%3D 10.1016/j.jpba.2007.01.006
    • (2007) J Pharm Biomed Anal , vol.43 , pp. 1706-1714
    • Camara, J.E.1    Satterfield, M.B.2    Nelson, B.C.3


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