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Polysorbate 80(for injection)

聚山梨酯80(供注射用)(1)

聚山梨酯80(供注射用)(1)

  • Product description
  • Product Description
    • In order to ensure the safety requirements of the products, on the basis of the common pharmaceutical grade polysorbate 80, Gedian Renfu Pharmaceutical has launched the polysorbate (for injection) products, and has completed the filing with the State Food and Drug Administration.
    • Compared with common pharmaceutical grade polysorbate 80, polysorbate 80 (for injection) products are prepared with high-purity raw materials. The side reactions and raw material residues are strictly controlled in the process, and the use of hydrogen peroxide is eliminated. The products have good color and purity. Guarantee the safety of use in injections.
     
    Application Range
    • Solubilizers and emulsifiers for injection products
     
    Product Advantages
    • Higher safety: sterility, control of bacterial endotoxin, meet the requirements of injection, ophthalmology, inhalation preparations
    • Higher purity: using oleic acid with a purity of more than 99% as raw material
    • Better appearance: Nearly colorless appearance for better quality
    • Better stability: Strictly control the free oleic acid and peroxide residues in the product, and adopt nitrogen-filling protection measures during the filling process to ensure consistent quality during product storage.
    • Lower impurity residue: strict control of ethylene glycol, diethylene glycol, triethylene glycol impurity residues
    • Good packaging: Under the standard conditions for injection, we designed 500g bottle, 2kg, 10kg, 20kg soft bag packaging specifications to meet the needs of different customers.
    • GMP-compliant production line to avoid cross-contamination
    聚山梨酯80(供注射用)
     
    Polysorbate 80 (for injection) fatty acid composition map
     
    Precautions
    • It should be stored in a sealed container, stored in a cool, dry place, and stored for too long, which will produce peroxide.
    • In the presence of polysorbate, the antibacterial activity of the preservative hydroxyphenyl ester will be reduced.

     

    Polysorbate 80
    (for injection)
    CP
    2015 edition (for injection)
    CP
    2015 edition (general pharmaceutical grade)
    Gedian Renfu Pharmaceutical Co-polysorbate 80 (for injection)
    Acid value
    ≤1.0
    ≤2.2
    ≤1.0
    POV
    ≤3
    ≤10
    ≤1
    PH
    5.0~7.5
    5.0~7.5
    5.0~7.5
    Absorbance
    Meet the requirements
    no request
    Meet the requirements
    Colour
    Must not be deeper than Yellow No. 2
    Compliance
    Must not be deeper than Yellow No. 2
    Ethylene glycol, diethylene glycol, triethylene glycol
    No more than 100ppm
    Compliance
    No more than 100ppm
    Moisture(%)
    ≤0.5
    ≤3
    ≤0.5
    Residue on ignition(%)
    ≤0.1
    ≤0.2
    ≤0.1
    Fatty acid composition
    Oleic acid should not be lower than 98%, others should not exceed 0.5%
    Compliance
    Oleic acid should not be lower than 99.0%, others should not exceed 0.5%
    Bacterial endotoxin
    <12EU/g
    no request
    <12EU/g
    microorganism
    Non-mandatory
    no request
    Meet the requirements

     

Hubei Gedian Humanwell Pharmaceutical Excipients Co.,Ltd 

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