Pharmaceutical
API's

Dihydrostreptomycin

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)

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