CN104428664B - 用于分析和测定在卫康醇中杂质的改良分析方法 - Google Patents

用于分析和测定在卫康醇中杂质的改良分析方法 Download PDF

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Publication number
CN104428664B
CN104428664B CN201380022154.4A CN201380022154A CN104428664B CN 104428664 B CN104428664 B CN 104428664B CN 201380022154 A CN201380022154 A CN 201380022154A CN 104428664 B CN104428664 B CN 104428664B
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analysis method
dianhydrogalactitol
ammonium
volatility
liquid chromatography
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CN104428664A (zh
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盧暁云
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Del Mar Pharmaceuticals
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Del Mar Pharmaceuticals
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    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N30/00Investigating or analysing materials by separation into components using adsorption, absorption or similar phenomena or using ion-exchange, e.g. chromatography or field flow fractionation
    • G01N30/02Column chromatography
    • G01N30/88Integrated analysis systems specially adapted therefor, not covered by a single one of the groups G01N30/04 - G01N30/86
    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N21/00Investigating or analysing materials by the use of optical means, i.e. using sub-millimetre waves, infrared, visible or ultraviolet light
    • G01N21/17Systems in which incident light is modified in accordance with the properties of the material investigated
    • G01N21/47Scattering, i.e. diffuse reflection
    • G01N21/49Scattering, i.e. diffuse reflection within a body or fluid
    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N30/00Investigating or analysing materials by separation into components using adsorption, absorption or similar phenomena or using ion-exchange, e.g. chromatography or field flow fractionation
    • G01N30/02Column chromatography
    • G01N30/04Preparation or injection of sample to be analysed
    • G01N30/06Preparation
    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N30/00Investigating or analysing materials by separation into components using adsorption, absorption or similar phenomena or using ion-exchange, e.g. chromatography or field flow fractionation
    • G01N30/02Column chromatography
    • G01N30/62Detectors specially adapted therefor
    • G01N30/72Mass spectrometers
    • G01N30/7233Mass spectrometers interfaced to liquid or supercritical fluid chromatograph
    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/15Medicinal preparations ; Physical properties thereof, e.g. dissolubility
    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N30/00Investigating or analysing materials by separation into components using adsorption, absorption or similar phenomena or using ion-exchange, e.g. chromatography or field flow fractionation
    • G01N30/02Column chromatography
    • G01N2030/022Column chromatography characterised by the kind of separation mechanism
    • G01N2030/027Liquid chromatography
    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N30/00Investigating or analysing materials by separation into components using adsorption, absorption or similar phenomena or using ion-exchange, e.g. chromatography or field flow fractionation
    • G01N30/02Column chromatography
    • G01N30/62Detectors specially adapted therefor
    • G01N30/74Optical detectors
    • G01N2030/743FTIR
    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N30/00Investigating or analysing materials by separation into components using adsorption, absorption or similar phenomena or using ion-exchange, e.g. chromatography or field flow fractionation
    • G01N30/02Column chromatography
    • G01N30/88Integrated analysis systems specially adapted therefor, not covered by a single one of the groups G01N30/04 - G01N30/86
    • G01N2030/8809Integrated analysis systems specially adapted therefor, not covered by a single one of the groups G01N30/04 - G01N30/86 analysis specially adapted for the sample
    • G01N2030/8813Integrated analysis systems specially adapted therefor, not covered by a single one of the groups G01N30/04 - G01N30/86 analysis specially adapted for the sample biological materials
    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N30/00Investigating or analysing materials by separation into components using adsorption, absorption or similar phenomena or using ion-exchange, e.g. chromatography or field flow fractionation
    • G01N30/02Column chromatography
    • G01N30/88Integrated analysis systems specially adapted therefor, not covered by a single one of the groups G01N30/04 - G01N30/86
    • G01N2030/8809Integrated analysis systems specially adapted therefor, not covered by a single one of the groups G01N30/04 - G01N30/86 analysis specially adapted for the sample
    • G01N2030/8872Integrated analysis systems specially adapted therefor, not covered by a single one of the groups G01N30/04 - G01N30/86 analysis specially adapted for the sample impurities
    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N30/00Investigating or analysing materials by separation into components using adsorption, absorption or similar phenomena or using ion-exchange, e.g. chromatography or field flow fractionation
    • G01N30/02Column chromatography
    • G01N30/62Detectors specially adapted therefor
    • G01N30/74Optical detectors
    • YGENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10TECHNICAL SUBJECTS COVERED BY FORMER USPC
    • Y10TTECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
    • Y10T436/00Chemistry: analytical and immunological testing
    • Y10T436/14Heterocyclic carbon compound [i.e., O, S, N, Se, Te, as only ring hetero atom]
    • Y10T436/142222Hetero-O [e.g., ascorbic acid, etc.]
    • YGENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10TECHNICAL SUBJECTS COVERED BY FORMER USPC
    • Y10TTECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
    • Y10T436/00Chemistry: analytical and immunological testing
    • Y10T436/20Oxygen containing
    • Y10T436/203332Hydroxyl containing

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  • Life Sciences & Earth Sciences (AREA)
  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Physics & Mathematics (AREA)
  • Immunology (AREA)
  • General Physics & Mathematics (AREA)
  • Pathology (AREA)
  • General Health & Medical Sciences (AREA)
  • Biochemistry (AREA)
  • Analytical Chemistry (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Medicinal Chemistry (AREA)
  • Food Science & Technology (AREA)
  • Biophysics (AREA)
  • Molecular Biology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Other Investigation Or Analysis Of Materials By Electrical Means (AREA)
  • Investigating Or Analysing Materials By Optical Means (AREA)
  • Spectroscopy & Molecular Physics (AREA)
CN201380022154.4A 2012-02-27 2013-02-26 用于分析和测定在卫康醇中杂质的改良分析方法 Expired - Fee Related CN104428664B (zh)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US201261603464P 2012-02-27 2012-02-27
US61/603,464 2012-02-27
PCT/IB2013/000793 WO2013128285A2 (en) 2012-02-27 2013-02-26 Improved analytical methods for analyzing and determining impurities in dianhydrogalactitol

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CN104428664A CN104428664A (zh) 2015-03-18
CN104428664B true CN104428664B (zh) 2018-09-21

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US (2) US10145824B2 (enExample)
EP (1) EP2820408A4 (enExample)
JP (1) JP6223364B2 (enExample)
KR (1) KR20140129306A (enExample)
CN (1) CN104428664B (enExample)
AU (1) AU2013227353B2 (enExample)
BR (1) BR112014021163A2 (enExample)
CA (1) CA2865709A1 (enExample)
CL (1) CL2014002276A1 (enExample)
HK (1) HK1208528A1 (enExample)
MX (1) MX2014010312A (enExample)
SG (1) SG11201405249QA (enExample)
WO (1) WO2013128285A2 (enExample)

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CN104428664B (zh) 2012-02-27 2018-09-21 德玛医药 用于分析和测定在卫康醇中杂质的改良分析方法
EP3071555A4 (en) * 2013-11-18 2017-05-31 Del Mar Pharmaceuticals Hplc analysis of impurities in dianhydrogalactitol
MX379918B (es) * 2015-11-25 2025-03-11 Del Mar Pharmaceuticals Bc Ltd Metodos para analisis y resolucion de preparaciones de dianhidrogalactitol y derivados o analogos del mismo.
US10927363B2 (en) 2016-04-04 2021-02-23 Mie University DNA sequence and expression vector for alginate lyase
CN106596751B (zh) * 2016-11-04 2020-05-19 天津大学 一种氯代消毒副产物二氯乙酰胺和三氯乙酰胺的高效液相色谱-电喷雾质谱检测方法
JP6988158B2 (ja) * 2017-05-11 2022-01-05 株式会社島津製作所 液体クロマトグラフ質量分析方法及び液体クロマトグラフ質量分析装置
CN108827998B (zh) * 2018-05-30 2021-06-22 中国计量科学研究院 一种采用定量核磁共振氢谱准确测量易挥发性物质纯度的方法
EP4022668B1 (en) * 2019-08-30 2023-11-29 DH Technologies Development Pte. Ltd. Method for mass spectrometry
EP4083620B1 (en) * 2021-04-30 2025-03-05 F. Hoffmann-La Roche AG Lc system and method with column backflushing
US12295919B2 (en) 2022-03-16 2025-05-13 Mie University Methods of treatment and prevention using 4-deoxy-L-erythro-5-hexoseulose uronic acid

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JPH04297868A (ja) * 1991-03-27 1992-10-21 Tonen Corp オリゴ糖の分析方法
JPH09229920A (ja) * 1996-02-26 1997-09-05 Kao Corp グラジェント液体クロマトグラフィー溶離液の処理方法
US6060525A (en) 1996-03-01 2000-05-09 Dionix Corporation Removal of borate in chromatography
US20030060434A1 (en) 1997-02-18 2003-03-27 Loretta Nielsen Combined tumor suppressor gene therapy and chemotherapy in the treatment of neoplasms
CA2359337C (en) * 1999-01-14 2005-09-13 Board Of Supervisors Of Louisiana State University And Agricultural And Mechanical College Process for the separation of sugars
US20020037328A1 (en) * 2000-06-01 2002-03-28 Brown Dennis M. Hexitol compositions and uses thereof
US20060148732A1 (en) * 2000-11-17 2006-07-06 Gutterman Jordan U Inhibition of NF-kappaB by triterpene compositions
US20030229237A1 (en) * 2002-04-02 2003-12-11 Haas Michael J. In situ production of fatty acid alkyl esters
JP2004294384A (ja) * 2003-03-28 2004-10-21 National Agriculture & Bio-Oriented Research Organization 1−デオキシノジリマイシンの測定方法
CA2819769C (en) * 2003-07-18 2016-06-28 Oakwood Laboratories, L.L.C. Prevention of molecular weight reduction of the polymer, impurity formation and gelling in polymer compositions
EP1747457B1 (en) * 2004-05-20 2011-11-30 Novartis AG Analysis of liquid chromatography eluates
JP2008076340A (ja) * 2006-09-25 2008-04-03 Toppan Printing Co Ltd 高感度検出方法およびその検出装置
US8772279B2 (en) * 2010-01-29 2014-07-08 Nerviano Medical Sciences S.R.L. 6,7-dihydroimidazo[1,5-a]pyrazin-8(5H)-one derivatives as protein kinase modulators
AU2011292045B2 (en) * 2010-08-18 2016-03-24 Del Mar Pharmaceuticals Method of synthesis of substituted hexitols such as dianhydrogalactitol
US9029164B2 (en) * 2012-02-27 2015-05-12 Del Mar Pharmaceuticals Analytical methods for analyzing and determining impurities in dianhydrogalactitol
CN104428664B (zh) 2012-02-27 2018-09-21 德玛医药 用于分析和测定在卫康醇中杂质的改良分析方法

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Publication number Publication date
AU2013227353A1 (en) 2014-09-25
EP2820408A2 (en) 2015-01-07
JP6223364B2 (ja) 2017-11-01
SG11201405249QA (en) 2014-10-30
CA2865709A1 (en) 2013-09-06
CN104428664A (zh) 2015-03-18
BR112014021163A2 (pt) 2020-10-27
WO2013128285A9 (en) 2014-02-27
KR20140129306A (ko) 2014-11-06
AU2013227353B2 (en) 2016-06-09
EP2820408A4 (en) 2015-11-18
WO2013128285A2 (en) 2013-09-06
JP2015508174A (ja) 2015-03-16
US10145824B2 (en) 2018-12-04
US9759698B2 (en) 2017-09-12
HK1208528A1 (en) 2016-03-04
MX2014010312A (es) 2015-04-14
US20140017798A1 (en) 2014-01-16
WO2013128285A3 (en) 2013-12-27
US20150027206A1 (en) 2015-01-29
CL2014002276A1 (es) 2014-12-19

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