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  4. Dapagliflozin CAS 461432-26-8
  • Dapagliflozin CAS 461432-26-8
  • Dapagliflozin CAS 461432-26-8
  • Dapagliflozin CAS 461432-26-8
  • Dapagliflozin CAS 461432-26-8
Dapagliflozin CAS 461432-26-8 Dapagliflozin CAS 461432-26-8 Dapagliflozin CAS 461432-26-8 Dapagliflozin CAS 461432-26-8

Dapagliflozin CAS 461432-26-8

  • Product Item:CAS 461432-26-8
  • CAS 461432-26-8
  • MF:C21h25clo6
  • Appearance:Off-white powder
  • Assay:99.5%
  • Dapagliflozin  , 461432-26-8  , C21h25clo6  , chemical  , drugs
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    Description

    Dapagliflozin is a new type of antidiabetic drug jointly developed by Bristol-Myers Squibb and AstraZeneca. It was approved by the European Medicines Agency (EMA) on November 12, 2012 and is the first to be approved. SGLT2 inhibitors for the treatment of type 2 diabetes are important candidates for the treatment of diabetes. They are used as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes.

    Product Name Dapagliflozin
    Reference USDMF standard
    Test Items Specifications Results
    Appearance Off-white to yellowish powder Off-white powder
    Identification 1) Infrared absorption spectrum corresponds to the spectrum obtained with Dapagliflozin RS. Conforms
    2) The retention time of the major peak of sample solution corresponds to that of the standard solution, as obtained in the assay. Conforms
    Water 3.4%-4.3% 3.6%
    Residue on ignition ≤0.1% <0.1%
    Related substances (HPLC) Five-membered heterocyclic impurity≤0.15% <LOD(LOD=0.01%)
    α-isomer≤0.15% <LOD(LOD=0.01%)
    Any unspecified impurity≤0.10% <LOD(LOD=0.01%)
    Total impurities≤1.0% <LOD
    Genotoxic impurity(LC/MS) Methyl methanesulfonate≤60ppm <LOD(LOD=7,Oppm)
    Assay (HPLC) 98.0% -102.0% (Calculated on anhydrous and solvent-free basis) 99.5%
    (S)-1,2-propanediol (GC) 13.6%-16.6% 13.8%
    Residual solvents (GC) Dichloromethane≤600ppm <LOD(LOD=54ppm)
    Ethyl acetate≤5000ppm <LOD(LOD=15ppm)
    Ethanol≤5000ppm <LOQ(LOQ=250ppm)
    Toluene≤890ppm <LOD(LOD=9ppm)
    Methanol≤3000ppm <LOD(LOD=81ppm)
    n-heptane≤5000ppm <LOD(LOD=2ppm)
    Tertrahydrofuran≤720ppm <LOD(LOD=8ppm)
    Cyclohexane≤3880ppm 34ppm
    Isopropyl acetate≤5000ppm 104ppm
    Conclusion Complies with USDMF standard


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