I.Description of products Name:iron dextran injection 10% Other name:Iron dextran complex, ferric dextranum, ferric dextran, iron complex CAS NO:9004-66-4 COMPOSITION: Per ml solution Iron-III(as hydroxide dextran complex) 100mg. INDICATIONS: Prevention and treatment of the ferri-deficiency Anemia in piglets, calve, sheep, goats and dogs. DOSAGE AND ADMINSTRATION: For deep intramuscular or subcutaneous injection. --Calves, piglets:4-8ml, daily, during 7days. Sheep, goats, dogs:3ml, daily, during 7days. Prevention: Piglets, calves:2ml once on the third day of life, to be repeated on the 21st day of life. Sows:5ml two weeks before the litter. II.Quality satandard:USP CERTIFICATE OF ANALYSIS PRODUCT NAME IRON DEXTRAN injection 10% ASSAY.10%(100mg Fe/ml) BATCH NO.20120211 Spec.USP 32 MANUFACTURING DATE:2012-02-11 REPORT DATEFeb 18, 2012EXPIRY DATE:2015-02-10 TEST ITEMSSTANDARD RESULTS CHARACTERS A DARK BROWN COLLOIDAL SOLUTION A DARK BROWN COLLOIDAL SOLUTION IDENTIFICATION COMPLIES WITH COMPLIES WITH PH 4.5~7.0 6.24 CHLORIDE 0.8%5~1.1% 1.0% LIMIT OF PHENOL <0.5% 0.45% BACTERIAL ENDOTOXINES<0.50 EU/mg Fe COMPLIES WITH ACUTE TOXICITY COMPLIES WITH COMPLIES WITH CONTENT OF IRON 95.05~105.0mgFe/ml 98.1mgFe/ml CONCLUSION:COMPLIES WITH THE USP32 III.More iron assay of iron dextran spec.Assay for iron Iron dextran injection 5%47.5-52.5mgFe/ml Iron dextran injection 10%95.0-105.0mgFe/ml Iron dextran injection 15%142.5-157.5mgFe/ml Iron dextran injection 20%190.0-210.0mgFe/ml Iron dextran powder 25% >25.0% Iron dextran powder 30% 28%-32% Iron dextran powder 40% >38.0%
IV.About package Packing:50ml/vial, 100ml/vial 12vials/Foam tray*4 Foam tray/carton=48vials/carton 10vials/Foam tray*4 Foam tray/carton=40vials/carton