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Pharmaceutical
API's

Dihydrostreptomycin

Dihydrostreptomycin Sulphate

  • Characters: a white or almost white powder, freely soluble in water, practically insoluble in acetone, in alcohol and in methanol. It may be hygroscopic.
  • Identification: A. The retention time of a major peak meets the Requirements. - E. Positive
  • Appearance of solution: Colour: not more intensely coloured than 5 - Clarity: not more opalescent than II
  • pH: 5.0 – 7.0
  • Specific optical rotation: -83.0° - -91.0°
  • Related substances: Impurity A: NMT 1.0 % - Impurity B: NMT 1.0 % - Impurity C: NMT 2.0 % - Any other impurity: NMT 1.0 % - Total of impurities: NMT 5.0 %
  • Heavy metals: NMT 20 ppm
  • Loss on drying: NMT 5.0 %
  • Sulfated ash: NMT 1.0 %
  • Bacterial endotoxins: less than 0.50 IU/mg
  • Abnormal toxicity: meets the requirements
  • Content (HPLC): sum of Dihydrostreptomycin Sulfate and Streptomycin - Sulfate: 95.0 % - 102.0 % -Streptomycin Sulfate: NMT 2.0 % (dried substances)
  • Sodium Metabisulfite limit: NMT 0.4 % (internal)
  • Potency: NLT 730 IU/mg (dried substances)

Download Ask for the Material Safety Data Sheet

Dihydrostreptomycin Sulphate Sterile

  • Characters: a white or almost white powder, freely soluble in water, practically insoluble in acetone, in alcohol and in
  • methanol. It may be hygroscopic.
  • Identification: A. The retention time of a major peak meets the Requirements. - E. Positive
  • Appearance of solution: Colour: not more intensely coloured than 5 - Clarity: not more opalescent than II
  • pH: 5.0 – 7.0
  • Specific optical rotation: -83.0° - -91.0°
  • Related substances: Impurity A: NMT 1.0 % - Impurity B: NMT 1.0 % - Impurity C: NMT 2.0 % - Any other impurity: NMT 1.0 % - Total of impurities: NMT 5.0 %
  • Heavy metals: NMT 20 ppm
  • Loss on drying: NMT 5.0 %
  • Sulfated ash: NMT 1.0 %
  • Bacterial endotoxins: less than 0.50 IU/mg
  • Abnormal toxicity: meets the requirements
  • Content (HPLC): sum of Dihydrostreptomycin Sulfate and Streptomycin - Sulfate: 95.0 % - 102.0 % - Streptomycin Sulfate: NMT 2.0 % (dried substances)
  • Sodium Metabisulfite limit: NMT 0.4 % (internal)
  • Potency: NLT 730 IU/mg (dried substances)
  • Bacterial endotoxins: less than 0.50 IU/mg
  • Sterility: meets the requirements

Download Ask for the Material Safety Data Sheet

  • GMP+
  • HACCP