Basic Info
  • Grade: food grade, pharmaceutical grade

    Factory Location: Hunan, China (Mainland)

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

  • Sample Provided: no

    Payment Terms: T/T,L/C,DP,BANK CONTRACT

    Glimepiride
    CAS No.: 93479-97-1
    Appearance: white cyrstalline Powder
    Assay(HPLC):99.59%

    Product Name

    Glimepiride

    Batch No

    20110701

    Produce Date

    2011 07 07

    Report Date

    2011 07 09

    Packing Standard

    20kg/drum

    Quantity

    20kg

    Ref Standard

    USP29 Standard

    Retest Date

    2013 07 07

    Results Of Analysis Tests

    Test Item

    Analysis Specification

    Result

    Description

    White to off white power

    white power

    Identification

    IR (similar to standard)

    Conforms

    Related substances by HPLC

       

    Impurity A(Cis-isomer)

    ≤0.8%

    0.13%

    Impurity B

    ≤0.4%

    0.16%

    Impurity C

    ≤0.1%

    0.05%

    Impurity D

    ≤0.2%

    0.11%

    Any other impurity

    ≤0.1%

    0.08%

    Total impurity

    ≤0.5%

    0.23%

    Heavy metals

    ≤10ppm

    <10ppm

    Loss on drying

    ≤0.5%

    0.19%

    Sulphated ash

    ≤0.1%

    0.07%

    Assay(HPLC)

    98.0%~102.0%

    99.59%

    Residual solvents

    To comply the test as pre USP<467>

    Complies

    Conclusion

    The results Conform with USP29 Standard

     

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