http://rdf.ncbi.nlm.nih.gov/pubchem/patent/CN-108373465-B

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classificationCPCInventive http://rdf.ncbi.nlm.nih.gov/pubchem/patentcpc/G01N30-02
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classificationIPCInventive http://rdf.ncbi.nlm.nih.gov/pubchem/patentipc/C07D401-12
http://rdf.ncbi.nlm.nih.gov/pubchem/patentipc/G01N30-02
filingDate 2018-04-13-04:00^^<http://www.w3.org/2001/XMLSchema#date>
grantDate 2020-04-07-04:00^^<http://www.w3.org/2001/XMLSchema#date>
publicationDate 2020-04-07-04:00^^<http://www.w3.org/2001/XMLSchema#date>
publicationNumber CN-108373465-B
titleOfInvention Dabigatran etexilate impurity and preparation and detection methods thereof
abstract The invention discloses a dabigatran etexilate impurity compound shown as a formula I and an impurity preparation and detection method, wherein the preparation method comprises the following steps: taking dabigatran etexilate and n-hexanol as raw materials, taking a mixture comprising an organic solvent and a buffer solution as a system solvent, reacting, and adjusting the pH of a reaction solution to 7.8-8.2, preferably 8.0 to obtain the compound; the detection method adopts high performance liquid chromatography for detection, and qualitatively or quantitatively detects impurities, and the detection conditions comprise: a chromatographic column: octadecylsilane chemically bonded silica gel column, detection wavelength: 210-400 nm, the mobile phase comprises a mobile phase A and a mobile phase B, and the mobile phase A: a water phase containing a buffer solution, the pH of which is 4.25 to 4.40, further 4.3; the mobile phase B mainly comprises methanol or acetonitrile; the mobile phase is eluted by a gradient elution method. The method provided by the invention improves the impurity control of dabigatran etexilate, further controls the product quality of dabigatran etexilate, and better meets the requirement of dabigatran etexilate consistency evaluation.
priorityDate 2018-04-13-04:00^^<http://www.w3.org/2001/XMLSchema#date>
type http://data.epo.org/linked-data/def/patent/Publication

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