Basic Info
  • Grade: Pharmaceutical Grade

    Factory Location: Hunan

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

  • Sample Provided: no

    GMP Gliclazide pharmaceutical raw materials/21187-98-4/Gliclazide powder /gliclazide made in China : 


    1.USP/BP/EP 
    2.offer the Documents (GMP, DMF ,COA and so on) 
    3.Place of origin:china

    gliclazide specification

    Items

    Acceptable criteria

    Results

    Characteristics

    A white or almost white powder

    A white powder

    Solubility

    Practically insoluble in water: freely soluble in methylene chloride;

    Sparingly soluble in acetone(96%); slightly soluble in alcohol (96%)

    Conforms

    M.P

    162-166°C

    164.0-164.5°C

    Identification

    Conform to the spectrum of the CRS Gliclazide

    Conforms

    Heavy metals

    ≤10ppm

    <10ppm

    Impurity B

    ≤2ppm

    0.3ppm

    Related substances

    Impurity F ≤0.10%

    <0.10%

    Other single impurity ≤0.10%

    <0.10%

    Total of other impurities ≤0.2%

    0.13%

    Loss on drying

    ≤0.25%

    0.1%

    Sulphated ash

    ≤0.1%

    0.01%

    Residual solvents

    Ethyl acetate ≤0.5%

    Below LOQ

    Toluene ≤0.089%

    Below LOQ

    Assay (on dried basis)

    99.0%-101.0%

    99.5%

    Conclusion

    The test results conform with EP7.0/BP2009/CP2010

     

    Storage:

    kept in a light-proof,well-colsed,dry and cool place.

    Packaging & Shipping

    25kg/fiber drum, or 25kg/carton 

    MOQ: 1 DRUM

    delivery time: 7-15 days after payment.

    Our Services

    We have more than 450 vendors, Arshine could save your effort to serve customers with supplying all your needs!

    Certifications: 

    • GMP
    • COS 

     

    Company Information

    Arshine is one of the professional suppliers for pharmaceutical raw materials for more than 12 years in China.

     Offer Original COA, MOA, GMP, sample and other need documents (to support the registration if you need).

     Vendors:  NCPC,CSPC, Guo Bang, Zhuhai United, Lv Yuan, Ningxia duowei, Hebei Yu Xing, Jin Xing, Jiheng,

    Kun Shan, Fengyuan, Jian Ming, XiongDi, Hebei dongfeng etc.   

    FAQ

    MOQ: 25kg

    Delivery time: 3-7 days after payment

    Payment term: L/C   D/A   D/P   T/T   Western union   MoneyGram  

    Supply ability: 50000 Kilogram/Kilograms / Month

    More information please kindly contact us.

    Shelf life: 3 years

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