BR112013022272A2 - método para a determinação de polissorbato - Google Patents

método para a determinação de polissorbato

Info

Publication number
BR112013022272A2
BR112013022272A2 BR112013022272A BR112013022272A BR112013022272A2 BR 112013022272 A2 BR112013022272 A2 BR 112013022272A2 BR 112013022272 A BR112013022272 A BR 112013022272A BR 112013022272 A BR112013022272 A BR 112013022272A BR 112013022272 A2 BR112013022272 A2 BR 112013022272A2
Authority
BR
Brazil
Prior art keywords
polysorbate
determining
alkaline hydrolysis
present
analyte
Prior art date
Application number
BR112013022272A
Other languages
English (en)
Other versions
BR112013022272B1 (pt
Inventor
Alfred Weber
Andrea Engelmaier
Hans-Peter Schwarz
Heinz Anderle
Original Assignee
Baxter Healthcare Sa
Baxter Int
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Baxter Healthcare Sa, Baxter Int filed Critical Baxter Healthcare Sa
Publication of BR112013022272A2 publication Critical patent/BR112013022272A2/pt
Publication of BR112013022272B1 publication Critical patent/BR112013022272B1/pt

Links

Classifications

    • 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
    • G01N33/48Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/50Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
    • 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
    • G01N21/25Colour; Spectral properties, i.e. comparison of effect of material on the light at two or more different wavelengths or wavelength bands
    • G01N21/31Investigating relative effect of material at wavelengths characteristic of specific elements or molecules, e.g. atomic absorption spectrometry
    • 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
    • G01N33/48Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/483Physical analysis of biological material
    • 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
    • G01N33/48Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/50Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
    • G01N33/92Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving lipids, e.g. cholesterol, lipoproteins, or their receptors
    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N2400/00Assays, e.g. immunoassays or enzyme assays, involving carbohydrates
    • 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
    • Y10T436/17Nitrogen containing
    • 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
    • Y10T436/17Nitrogen containing
    • Y10T436/172307Cyanide or isocyanide
    • 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
    • Y10T436/17Nitrogen containing
    • Y10T436/173076Nitrite or nitrate
    • 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
    • Y10T436/17Nitrogen containing
    • Y10T436/173845Amine and quaternary ammonium
    • 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
    • Y10T436/25Chemistry: analytical and immunological testing including sample preparation
    • 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
    • Y10T436/25Chemistry: analytical and immunological testing including sample preparation
    • Y10T436/25125Digestion or removing interfering materials
    • 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
    • Y10T436/25Chemistry: analytical and immunological testing including sample preparation
    • Y10T436/25375Liberation or purification of sample or separation of material from a sample [e.g., filtering, centrifuging, etc.]

Landscapes

  • Life Sciences & Earth Sciences (AREA)
  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Chemical & Material Sciences (AREA)
  • Molecular Biology (AREA)
  • Biomedical Technology (AREA)
  • Immunology (AREA)
  • Urology & Nephrology (AREA)
  • Hematology (AREA)
  • Physics & Mathematics (AREA)
  • General Physics & Mathematics (AREA)
  • General Health & Medical Sciences (AREA)
  • Pathology (AREA)
  • Analytical Chemistry (AREA)
  • Biochemistry (AREA)
  • Food Science & Technology (AREA)
  • Medicinal Chemistry (AREA)
  • Cell Biology (AREA)
  • Biotechnology (AREA)
  • Microbiology (AREA)
  • Biophysics (AREA)
  • Spectroscopy & Molecular Physics (AREA)
  • Endocrinology (AREA)
  • Investigating Or Analysing Biological Materials (AREA)
  • Investigating Or Analyzing Non-Biological Materials By The Use Of Chemical Means (AREA)

Abstract

método para a determinação de polissorbato a presente invenção refere-se a um método para a determinação de polissorbato em uma amostra contendo proteína. o método da presente invenção envolve o pré-tratamento da amostra por hidrólise alcalina, seguido por determinação colorimétrica baseada no complexo de metal do analito com um reagente de tiocianato, o complexo sendo extraído em um solvente orgânico imiscível. a hidrólise alcalina é responsável pela remoção das proteínas interferentes e intensifica a seletividade sobre os tensoativos similares ao analito, por exemplo, para tween 80 sobre triton x-100.
BR112013022272-7A 2011-03-04 2012-03-01 Método para a determinação de polissorbato BR112013022272B1 (pt)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US201161449535P 2011-03-04 2011-03-04
US61/449,535 2011-03-04
PCT/EP2012/000898 WO2012119724A1 (en) 2011-03-04 2012-03-01 Method for the determination of polysorbate

Publications (2)

Publication Number Publication Date
BR112013022272A2 true BR112013022272A2 (pt) 2016-12-06
BR112013022272B1 BR112013022272B1 (pt) 2021-09-08

Family

ID=45841439

Family Applications (1)

Application Number Title Priority Date Filing Date
BR112013022272-7A BR112013022272B1 (pt) 2011-03-04 2012-03-01 Método para a determinação de polissorbato

Country Status (19)

Country Link
US (1) US8603830B2 (pt)
EP (1) EP2681553B1 (pt)
JP (1) JP5954799B2 (pt)
KR (1) KR101910217B1 (pt)
CN (1) CN103403544B (pt)
AU (1) AU2012224949B2 (pt)
BR (1) BR112013022272B1 (pt)
CA (1) CA2828629C (pt)
CY (1) CY1119182T1 (pt)
DK (1) DK2681553T3 (pt)
ES (1) ES2641618T3 (pt)
HU (1) HUE033066T2 (pt)
IL (1) IL228073A (pt)
LT (1) LT2681553T (pt)
PT (1) PT2681553T (pt)
RU (1) RU2583132C2 (pt)
SG (1) SG192977A1 (pt)
SI (1) SI2681553T1 (pt)
WO (1) WO2012119724A1 (pt)

Families Citing this family (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN104483487B (zh) * 2014-12-22 2017-01-25 宁波美康生物科技股份有限公司 检测人血液中1,5‑脱水山梨醇的试剂盒
CN111033261A (zh) * 2017-06-27 2020-04-17 科里奥利医药研究有限责任公司 聚山梨醇酯的定量分析
CN107478591A (zh) * 2017-08-16 2017-12-15 中国食品药品检定研究院 一种中药注射剂中聚山梨酯80的含量测定方法
RU2670965C9 (ru) * 2017-12-14 2018-11-21 Общество с ограниченной ответственностью "Международный Биотехнологический Центр "Генериум" Способ измерения количества полисорбата-80 с применением щелочного гидролиза образца с последующей вэжх
CN111610324B (zh) * 2020-06-06 2022-10-14 北京均大检测科技有限公司 一种ripa裂解液及其制备方法
US11141383B1 (en) * 2020-06-24 2021-10-12 King Abdulaziz University Drug loaded flexible chitoplexes nanoparticles
CN113406237B (zh) * 2021-06-23 2023-05-09 宝船生物医药科技(上海)有限公司 一种基于固相萃取检测单克隆抗体注射液中吐温80含量的方法

Family Cites Families (11)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6270672B1 (en) * 1999-08-06 2001-08-07 Baxter Aktiengesellschaft Devices and methods for removing pathogens from biological fluids
JP2001249135A (ja) * 2000-03-03 2001-09-14 Tokuyama Corp ペプチド結合でタンパク質に結合したホモシステインの測定方法
RU2163379C1 (ru) * 2000-04-14 2001-02-20 Пермский научно-исследовательский клинический институт детской экопатологии Способ количественного определения хлороформа и тетрахлорметана в крови
JP4236934B2 (ja) * 2001-04-17 2009-03-11 中外製薬株式会社 界面活性剤の定量方法
US20030133829A1 (en) * 2001-12-21 2003-07-17 Baxter Healthcare Corporation Process for inactivating pathogens in a biological material
GB0310347D0 (en) * 2003-05-07 2003-06-11 Delta Biotechnology Ltd Assay
CN101097217A (zh) * 2006-06-29 2008-01-02 王珊珊 一种提高血清特异性生长因子免疫学测定灵敏度的技术
JP5273766B2 (ja) * 2007-11-13 2013-08-28 独立行政法人理化学研究所 タンパク質加水分解方法および装置、ならびに、タンパク質分析方法および装置
CN101639439A (zh) * 2008-07-28 2010-02-03 东莞太力生物工程有限公司 一种测定蛋白质溶液中聚山梨酯含量的方法
CN101839439A (zh) 2009-03-20 2010-09-22 秦志祥 防眩灯罩
CN101852739B (zh) * 2010-05-21 2012-05-16 东北师范大学 一种聚山梨酯非离子型表面活性剂的测定方法

Also Published As

Publication number Publication date
AU2012224949A1 (en) 2013-05-02
JP5954799B2 (ja) 2016-07-20
KR20140008423A (ko) 2014-01-21
HUE033066T2 (hu) 2017-11-28
RU2013144587A (ru) 2015-04-10
LT2681553T (lt) 2017-11-10
KR101910217B1 (ko) 2018-10-19
IL228073A0 (en) 2013-09-30
JP2014508297A (ja) 2014-04-03
CN103403544B (zh) 2016-01-27
CN103403544A (zh) 2013-11-20
WO2012119724A1 (en) 2012-09-13
BR112013022272B1 (pt) 2021-09-08
DK2681553T3 (en) 2017-08-28
EP2681553B1 (en) 2017-05-10
CA2828629A1 (en) 2012-09-13
SG192977A1 (en) 2013-09-30
PT2681553T (pt) 2017-08-16
CY1119182T1 (el) 2018-02-14
US20120225487A1 (en) 2012-09-06
US8603830B2 (en) 2013-12-10
SI2681553T1 (sl) 2017-09-29
ES2641618T3 (es) 2017-11-10
CA2828629C (en) 2019-07-16
IL228073A (en) 2017-03-30
RU2583132C2 (ru) 2016-05-10
EP2681553A1 (en) 2014-01-08
AU2012224949B2 (en) 2015-02-19

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Legal Events

Date Code Title Description
B25A Requested transfer of rights approved

Owner name: BAXALTA GMBH (CH) , BAXALTA INCORPORATED (US)

B06U Preliminary requirement: requests with searches performed by other patent offices: procedure suspended [chapter 6.21 patent gazette]
B06A Patent application procedure suspended [chapter 6.1 patent gazette]
B09A Decision: intention to grant [chapter 9.1 patent gazette]
B25A Requested transfer of rights approved

Owner name: TAKEDA PHARMACEUTICAL COMPANY LIMITED (JP)

B16A Patent or certificate of addition of invention granted [chapter 16.1 patent gazette]

Free format text: PRAZO DE VALIDADE: 20 (VINTE) ANOS CONTADOS A PARTIR DE 01/03/2012, OBSERVADAS AS CONDICOES LEGAIS.