Ceftiofur sodium

Items Specifications Results Characters Appearance White or almost white, fine crystalline powder conforms Solubility Very slightly soluble in water, freely soluble in methylene chloride, soluble methanol, sparingly soluble in ethanol(96%) conforms Identification A) IR Conforms to Amiodarone Hydrochloride CRS Conforms B) Chlorides It gives reactions of chlorides Conforms Appearance of solution clear, NMT GY5 Conforms Melting Range 159~163°C 159.0~160.0°C pH 3.2~3.8 3.63 Impurity H (by TLC) NMT 0.02% <0.02% Related Substance (by HPLC ) Impurity A NMT 0.20% 0.07% Impurity B NMT 0.20% 0.10% Impurity C NMT 0.20% conforms Impurity D NMT 0.20% 0.05% Impurity E NMT 0.20% 0.03% Impurity F NMT 0.20% conforms Impurity G NMT 0.20% 0.01% Unspecified impurities NMT 0.20% 0.02% Total impurities NMT 0.20% 0.34% Iodides NMT 150ppm <150ppm Heavy metals NMT 20ppm <20ppm Loss on drying NMT 0.5% 0.08% Sulphated ash NMT 0.1% 0.02% Assay 98.5%~101.0% 100.00% Residual Solvents Ethanol NMT5000ppm 782ppm Toluene NMT890ppm 94ppm Conclusion The results can conforms with the EP6