gentamycin sulfate injection

gentamycin sulfate injection COS, GMP CERTIFICATE, DMF OPEN PART BP/EP Characters A white or almost white powder, freely soluble in water, Practically insoluble in alcohol and in ether Complies Identification Tests according to monograph Complies Appearance of solution Clear and not more intensely colored than degree 6 of the range of reference solutions of the most appropriate color Complies PH 3.5-5.5 4.7 Specific optical rotation +107° to +121° +117° Methanol Not more than 1.0% Complies Composition C1 25.0 to 50.0% C1a 10.0 to 35.0% C2a+C2 25.0 to 55.0% 25.3% 27.8% 46.9% Water Not more than 15% 9.6% Sulphated ash Not more than 1.0% 0.2% Sulphate 32.0 to 35.0% 34.3% Sterility Complies with the test for sterility Complies Bacterial endotoxin Not more than 0.71 IU/mg Complies Assay Not less than 590 IU/mg (anhydrous substance) (hydrous substance) 666 IU/mg 602 IU/mg