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Basic Info

  • Grade: Pharmaceutical Grade

    Factory Location: Xiamen, Fujian

    Main Sales Markets: North America,Central/South America,Western Europe,Eastern Europe,Australasia,Asia,Middle East

  • Monthly Production Capacity: 1000kg

    Packaging Information: 25kg/drum 1kg/bottle

  • Delivery Lead Time: 7 days after payment

    Sample Provided: yes

    Payment Terms: L/L

    Testing

    Specification

    Results

     

    Appearance

     

    Identification

     

     

    Residue on Ignition

     

    Heavy Metals

     

    Water

     

    Specific Optical Rotation

     

    Impurity

    Spirooxiran 1

    Spirooxiran 2

    Exemestane related(Compound C)

    Exemestane related(Compound A)

    Any unspecified impurity

    Total impurity

     

    Assay(HPLC)

     

    Micron

     

     

    White crystalline powder

     

    IR

    RT (HPLC)

     

    0.1% Max

     

    10PPM Max

     

    0.5% Max

     

    +290° to  +300°

     

     

    0.15% Max

    0.15% Max

    0.15% Max

    0.15% Max

    0.1% Max

    0.5% Max

     

    98% to 10.2%

     

    100% Less than 20μm

     

    Conform

     

    Conform

    Conform

     

    0.04%

     

    Conform

     

    0.03%

     

    +290.86°

     

     

    Not Detected

    Not Detected

    Not Detected

    Not Detected

    0.05%

    0.25%

     

    100.02%

     

    Conform

     

    Conclusion:       Up to Standard for USP Pending Monograph

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