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Pharmaceutical
API's

Gentamycin

Gentamycin Sulphate

  • Aspect: White or almost white powder
  • Formula: C22H24N2O9·HCL
  • Identification: B)The chromatogram obtained with the test solution shows 5 principal peak having the same retention times as the 5 principal peaks in the chromatogram obtained with reference solution - C)It gives reaction(a)of sulfates
  • Specific optical rotation: +107°~+121°
  • pH: 3.5 – 5.5
  • Appearance of solution: Clarity:clear - Colour: Not more intensely coloured than intensity 6 of the range of reference solutions of the most appropriate colour.
  • Methanol: Maximum 1.0 %
  • Composition(HPLC): C1:25.0%-45.0% - C1a:10.0%-30.0% - C2a+C2+C2b:35.0%-55.0%
  • Water: Maximum 15.0%
  • Sulphated ash: Maximum 1.0 %
  • Sulphate (anhydrous): 32.0 – 35.0 %
  • Related Substances: Impurities A:Max 3.0% - Impurities B:Max 3.0% - Any other impurity:Max 3.0% - Total:Max 10.0%
  • Assay: ≥590 IU/mg(anhydrous)
  • Solubility: Freely soluble in water, practically insoluble in alcohol and in ether..
  • Expiry Date: Four years after production date
  • Storage: In an airtight container
  • Transport information: See our latest safety data sheet
  • Safety data sheet: Yes
  • Classified as hazardous as per EU regulation: See our latest safety data sheet

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Gentamycin Sulphate Sterile

  • Characters: a white or almost white powder, freely soluble in water, practically insoluble in alcohol and in ether.
  • Identification: tests according to monograph
  • Appearance of solution: clear and not more intensely colored than degree 6 of the range of reference solutions of the most appropriate colour.
  • pH: 3.5 to 5.5
  • Specific optical rotation: +107° to +121°
  • Methanol: NMT 1.0 %
  • Composition: C1 – 25.0 to 50.0 % - C1A: 10.0 to 35.0 % - C2A + C2: 25.0 to 55.0 %
  • Water: NMT 15.0 %
  • Sulphated ash: NMT 1.0 %
  • Sulphate: 32.0 to 35.0 %
  • Sterility: complies with the test for sterility
  • Bacterial endotoxins: less than 1.67 IU/mg
  • Assay: not less than 590 IU/mg (anhydrous substance)

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  • GMP+
  • HACCP