China Ep USP Enrofloxacin CAS 93106-60-6

IdentificationName EnrofloxacinSynonyms 1-Cyclopropyl-7-(4-ethyl-1-piperazinyl)-6-fluoro-1,4-dihydro-4-oxo-3-quinolinecarboxylic acid Molecular Structure
Molecular Formula C19H22FN3O3Molecular Weight 359.40CAS Registry Number 93106-60-6

Test ItemsStandardAppearancePale yellowish or light yellow crystalline powderSolubilityPractically insoluble in water,freely soluble in methylene chloride,slightly soluble in methanol.IdentificationIR:Conforms to the spectrum of enrofloxacin CRSAppearance of solutionNot more opalescent than reference suspension II and not more intensely coloured reference solution GY4.Impurity A≤0.2%Ralated substance
Impurity B
Impurity C
Unspecified impurity
Total impurity
≤0.5%
≤0.2%
≤0.2%
≤1.0%Ralated substances
Ethanol
Isoamyl alcohol
Methanol
Toluene
N,N-dimethylformaminde
≤200ppm
≤100ppm
≤200ppm
≤100ppm
≤880ppmLoss on drying≤1.0%Sulphated ash≤0.1%Heavy metals≤ 20 ppmAssay(on drying basis)98.5%~101.5%

It is unlikely that an acute overdose of either compound would result in symptoms more serious than either anorexia or vomiting, but the adverse effects noted above could occur. Dogs receiving 10 times the labeled dosage rate of enrofloxacin for at least 14 days developed only vomiting and anorexia. Death did occur in some dogs when fed 25 times the labeled rate for 11 days, however.