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Lactose (for injection)

  • Product description
  • Product Description
    • Lactose for inhalation and lactose for injection are a sieved crystalline lactose for dry powder inhalation and for injection.
    • Compared with ordinary lactose, it has more strict control on impurity absorbance, protein, microorganisms and bacterial endotoxin to ensure the requirements of dry powder inhalation.
     
    Application Range
    • Thinner for powder inhalers
    • Freeze-dried preparation excipient
     
    Product Advantages
    • Has a smooth surface and a narrow particle size distribution
    • Excellent fluidity and physical and chemical stability
    • With lower impurities and protein residues, more stringent microbial and bacterial endotoxin control

     

     
    Limit
    Gedian Renfu medicine auxiliary inhalation lactose
    Impurity absorbance
    400nm (0.1g/ml) does not exceed 0.04
    270-300nm (0.1g/ml) without regulations
    210-220nm (0.01g/ml) does not exceed 0.25
    270-300nm (0.01g/ml) does not exceed 0.07
    0.008
    0.027
    0.032
    0.002
    Protein
    0.02%
    <100ppm
    Microorganism
    Total bacteria 100, mold/yeast 10
    not detected
    Bacterial endotoxin
    <5 EU/g
    <5 EU/g
     
    Lactose (for inhalation) absorbance diagram
     
    Lactose (for inhalation) absorbance diagram
     
    Precautions
    • Lactose and primary amine compounds can undergo Maillard condensation reaction to form brown product
    • Lactose has incompatibility with amino acids, aminophylline, amphetamine and lisinopril

Hubei Gedian Humanwell Pharmaceutical Excipients Co.,Ltd 

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