WO2019087069A3 - Pimavanserin tartrate impurities, processes for their preparation, and their use as reference standards - Google Patents

Pimavanserin tartrate impurities, processes for their preparation, and their use as reference standards Download PDF

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Publication number
WO2019087069A3
WO2019087069A3 PCT/IB2018/058498 IB2018058498W WO2019087069A3 WO 2019087069 A3 WO2019087069 A3 WO 2019087069A3 IB 2018058498 W IB2018058498 W IB 2018058498W WO 2019087069 A3 WO2019087069 A3 WO 2019087069A3
Authority
WO
WIPO (PCT)
Prior art keywords
impurities
processes
preparation
pimavanserin tartrate
reference standards
Prior art date
Application number
PCT/IB2018/058498
Other languages
French (fr)
Other versions
WO2019087069A2 (en
Inventor
Sairab Khan
Kaushal Nayyar
Mohan Prasad
Original Assignee
Sun Pharmaceutical Industries Limited
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 Sun Pharmaceutical Industries Limited filed Critical Sun Pharmaceutical Industries Limited
Publication of WO2019087069A2 publication Critical patent/WO2019087069A2/en
Publication of WO2019087069A3 publication Critical patent/WO2019087069A3/en

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Classifications

    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07CACYCLIC OR CARBOCYCLIC COMPOUNDS
    • C07C217/00Compounds containing amino and etherified hydroxy groups bound to the same carbon skeleton
    • C07C217/54Compounds containing amino and etherified hydroxy groups bound to the same carbon skeleton having etherified hydroxy groups bound to carbon atoms of at least one six-membered aromatic ring and amino groups bound to acyclic carbon atoms or to carbon atoms of rings other than six-membered aromatic rings of the same carbon skeleton
    • C07C217/56Compounds containing amino and etherified hydroxy groups bound to the same carbon skeleton having etherified hydroxy groups bound to carbon atoms of at least one six-membered aromatic ring and amino groups bound to acyclic carbon atoms or to carbon atoms of rings other than six-membered aromatic rings of the same carbon skeleton with amino groups linked to the six-membered aromatic ring, or to the condensed ring system containing that ring, by carbon chains not further substituted by singly-bound oxygen atoms
    • C07C217/58Compounds containing amino and etherified hydroxy groups bound to the same carbon skeleton having etherified hydroxy groups bound to carbon atoms of at least one six-membered aromatic ring and amino groups bound to acyclic carbon atoms or to carbon atoms of rings other than six-membered aromatic rings of the same carbon skeleton with amino groups linked to the six-membered aromatic ring, or to the condensed ring system containing that ring, by carbon chains not further substituted by singly-bound oxygen atoms with amino groups and the six-membered aromatic ring, or the condensed ring system containing that ring, bound to the same carbon atom of the carbon chain
    • 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
    • G01N2030/621Detectors specially adapted therefor signal-to-noise ratio
    • G01N2030/625Detectors specially adapted therefor signal-to-noise ratio by measuring reference material, e.g. carrier without sample
    • 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
    • G01N30/88Integrated analysis systems specially adapted therefor, not covered by a single one of the groups G01N30/04 - G01N30/86

Landscapes

  • Chemical & Material Sciences (AREA)
  • Organic Chemistry (AREA)
  • Organic Low-Molecular-Weight Compounds And Preparation Thereof (AREA)
  • Heterocyclic Carbon Compounds Containing A Hetero Ring Having Oxygen Or Sulfur (AREA)
  • Peptides Or Proteins (AREA)

Abstract

The present disclosure provides impurities of pimavanserin tartrate, processes for the preparation of the disclosed impurities, and the use of the disclosed impurities as reference standards in a chromatographic method for analyzing the purity of pimavanserin tartrate, or a dosage form comprising pimavanserin tartrate.
PCT/IB2018/058498 2017-10-30 2018-10-30 Pimavanserin tartrate impurities, processes for their preparation, and their use as reference standards WO2019087069A2 (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
IN201711038471 2017-10-30
IN201711038471 2017-10-30

Publications (2)

Publication Number Publication Date
WO2019087069A2 WO2019087069A2 (en) 2019-05-09
WO2019087069A3 true WO2019087069A3 (en) 2019-08-29

Family

ID=66331400

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/IB2018/058498 WO2019087069A2 (en) 2017-10-30 2018-10-30 Pimavanserin tartrate impurities, processes for their preparation, and their use as reference standards

Country Status (1)

Country Link
WO (1) WO2019087069A2 (en)

Families Citing this family (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2019087069A2 (en) * 2017-10-30 2019-05-09 Sun Pharmaceutical Industries Limited Pimavanserin tartrate impurities, processes for their preparation, and their use as reference standards

Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2010111353A1 (en) * 2009-03-25 2010-09-30 Acadia Pharmaceuticals, Inc. N-substituted piperidine derivatives as serotonin receptor agents
WO2016141003A1 (en) * 2015-03-02 2016-09-09 Teva Pharmaceutical Industries Ltd. Processes and intermediates for the preparation of pimavanserin
WO2017036432A1 (en) * 2015-09-02 2017-03-09 Zentiva, K.S. A production method of 1-(4-fluorobenzyl)-3-(4-isobutoxybenzyl)-1-(1-methylpiperidin- 4— yl)urea and its deuterated analogs not containing dimeric impurities
WO2019087069A2 (en) * 2017-10-30 2019-05-09 Sun Pharmaceutical Industries Limited Pimavanserin tartrate impurities, processes for their preparation, and their use as reference standards

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2010111353A1 (en) * 2009-03-25 2010-09-30 Acadia Pharmaceuticals, Inc. N-substituted piperidine derivatives as serotonin receptor agents
WO2016141003A1 (en) * 2015-03-02 2016-09-09 Teva Pharmaceutical Industries Ltd. Processes and intermediates for the preparation of pimavanserin
WO2017036432A1 (en) * 2015-09-02 2017-03-09 Zentiva, K.S. A production method of 1-(4-fluorobenzyl)-3-(4-isobutoxybenzyl)-1-(1-methylpiperidin- 4— yl)urea and its deuterated analogs not containing dimeric impurities
WO2019087069A2 (en) * 2017-10-30 2019-05-09 Sun Pharmaceutical Industries Limited Pimavanserin tartrate impurities, processes for their preparation, and their use as reference standards

Also Published As

Publication number Publication date
WO2019087069A2 (en) 2019-05-09

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