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    Coa Diquafosol Sodium Shandongkehui

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    Coa Diquafosol Sodium Shandongkehui

    Uploaded by

    rashidulhasan789
    10 views2 pages

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    10 views2 pages

    Coa Diquafosol Sodium Shandongkehui

    Uploaded by

    rashidulhasan789

    Copyright:

    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd
    Download as pdf or txt
    of 2

    山东 科汇药业有限公司

    Shandong Kehui Pharmaceutical Co., Ltd.


    No. 9A1, Tianheng Road, Changjia Town, Gaoqing County, Zibo City, Shandong Province., China

    CERTIFICATE OF ANALYSIS
    Product Name Diquafosol sodium Quantity 38KG
    Manufacturing date 02-06-2024 Batch NO DIQ20240601
    Test date 03-06-2024 Retest date 01-06-2026
    Structure

    CAS number:211427-08-6
    Molecular formula: C18H27N4NaO23P4
    Molecular weight:814.3
    ITEMS STANDARDS RESULTS
    Appearance
    while to off- white crystalline powder Conforms
    Solubility Freely soluble in dimethyl formamide. soluble in water,
    very slightly soluble in methanol and practically
    insoluble in anhydrous ethanol. Conforms
    Melting Point
    For information >180°C
    Residue on Ignition
    ≤0.1% 0.02%
    Specific Rotation
    -8°~-10° -8.5°
    Identification Retention Time: Similar to Reference Substance
    IR:Similar lo Reference Substance
    Sodium:The aqueous solution of this product shows the
    sodium salt identification reaction Conforms
    Chiral impurity ≤0.15% ND
    Chloride ≤0.02% Conforms
    Sulfate ≤0.02% Conforms
    Related Substances Uridine -5’-monophosphate disodium ≤0.10% ND
    Any other single impurity≤0.15% ND
    Total impurities <l.0% 0.06%
    Water Content 5%-11.0% 8.7%
    Heavy metal ≤10ppm Conforms
    Arsenic ≤0.0001% Conforms
    PSD D10≤5um 1.74um
    D50≤10um 5.44um
    D90≤50um 13.43um
    Bulk Density For information 0.2257g/ml
    Tap Density For information 0.4162g/ml
    Solvent Residue Dichloromethane≤600ppm ND
    Ethanol≤5000ppm 16ppm
    N.N-Dimethylformamide≤880ppm ND
    Triethylamine≤5000ppm ＜0.9ppm
    Assay 98.0%-102.0% 100.1%
    Microbial Limit TAMC≤100 cfu/g 2 cfu/g
    TYMC≤10 cfu/g ＜1cfu/g
    Escherichia coli Conforms
    Staphylococcus aureus Conforms
    Pseudomonas aeruginosa Conforms
    Salmonella sp. Conforms
    Conclusion This above results meet the specification accord with the enter price
    standard

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