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Ursodeoxycholic Acid(UDCA) of Deebio for Treating Gallstones


  • CAS NO.: 128-13-2
  • HS CODE: 3504.0090.00
  • Product Detail

    Product Tags

    Detail

    1. Characters: White powder; odorless. This product is soluble in ethanol, but insoluble in chloroform; soluble in glacial acetic acid, and soluble in sodium hydroxide test solution.

    2. Process: Synthetic.

    3. Indications and uses: For the treatment of gallstones, cholestatic liver disease, fatty liver, various types of hepatitis, toxic liver disorders, cholecystitis, cholecystitis and biliary dyspepsia, bile reflux gastritis, etc.

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    Why us?

    ·Produced in the GMP workshop

    ·27 years of biological enzyme R&D history

    ·Raw materials are traceable

    ·Comply with customer and enterprise standard

    ·Export to over 30 countries and regions

    ·Has the ability of quality system management such as US FDA, Japan PMDA, South Korea MFDS, etc.

    Specification

    Test Items

    According to internal standard and Customer Standard

    APPEARANCE

    White or almost white powder.

    MELTING RANGE

    Between 200°C and 205°C

    SPECIFIC ROTATION

    +57.0 〜+62.0°

    LOSS ON DRYING

    ≤0.5%

    RESIDUE ON IGNITION

    ≤0.1%

    ASSAY

    98.5%〜101.5% (Dried substance)

    PURITY (HPLC)

    ≥98.5%

    RELATED SUBSTANCE (HPLC)

    ≤1.5% (Chenodeoxycholicacid)

    Not detected

    ≤0.1% (Unspecified impurities)

    0.05%

    ≤0.1% (Lithocholicacid)

    Not detected

    ≤1.5% (Total)

    0.10%

    RELATED SUBSTANCE (TLC)

    ≤O.05% (Lithocholic acid)

    Complies

    ≤1.5% (Chenodeoxycholicacid)

    Complies

    RESIDUAL SOLVENT

    Acetone: ≤5000ppm

    TOTAL AEROBIC MICROBIAL COUNT

    <103cfu/g

    TOTAL COMBINED YEAST/MOULDS COUNT

    <102cfu/g

    E.COLI

    Complies

    SALMONELLAE

    Complies

    CONCLUSION

    Qualified


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