More iron assay of iron dextran spec.Assay for iron Iron dextran solution 5%47.5-52.5mgFe/ml Iron dextran solution 10%95.0-105.0mgFe/ml Iron dextran solution 15%142.5-157.5mgFe/ml Iron dextran solution 20%190.0-210.0mgFe/ml Iron dextran powder 25% >25.0% Iron dextran powder 30% 28%-32% Iron dextran powder 40% >38.0%
I.Description of products 1)Name:iron dextran 10% Other name:Iron dextran complex, ferric dextranum, ferric dextran, iron complex 2)CAS NO:9004-66-4 3)Quality Standard:I.CVP2010 II.USP34 4)Molecular formula:(C6H10O5)n.[Fe(OH)3]m 5)Description:It is a dark brown colloidal crystalloid solution, phenol in flavour 6)Effect:It is an anti-anemia medicine, which can be used in the iron-deficiency anemia of a newborn piggy and other animals. 7)Characteristic:The ferric content is one of the highest in the similar products in the world.So it use just little.It is safe and absorbable quickly and has a good effect as well.
Toxicology Experiment:The half oral lethal dosis of a mouse(LD50) is 25000mg/kg, which belongs to the nontoxic degree.

II.Quality satandard:USP PRODUCT NAMEIRON DEXTRAN 10% ASSAY:10% (100mg Fe/ml) BATCH NO.20120211 Spec:USP 32MANUFACTURING DATE:2012-02-11 REPORT DATE:Feb 18, 2012EXPIRY DATE:2015-02-10
TEST ITEMS STANDARD 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%~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 95.0~105.0mgFe/ml 98.1mgFe/ml REMARK:TEST ACUTE TOXICITY BACTERIAL ENDOTOXINES.IRON ABSORPTION AFTER STERILIZE THE PRODUCT. CONCLUSION:COMPLIES WITH THE USP32
III:Application:It can be made into ferric injection through repack directly. 1.OPERATION DEMAND I.Filling:Roughly clean the bottle with Purified Water, and then Precision Clean with water for injection.Drying in a drying room and then Filling and Sealing. II.Sterilization:114±3 20 or30 minutes III.After refrigeration.wipe bottle and bottle cap clean and then test under light, remove the bottle which ullage, air leakage and have impurity. IV.After Labeling and packing to obtain finish products. (For reference only) V.About package 25L 50L 200L 25L HDPE drum:Mean.29*27*42cm, Weight:1.6KG 50L HDPE drum:Mean.38*59cm, Weight:3KG 200L HDPE drum:Mean.59*92cm, Weight:10KG