Pharmaceutical
API's

Gentamycin

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% - C_1a：10.0%-30.0% - C_2a+C₂+C_2b：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

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)