Description

More iron assay of iron dextran
spec.Assay for iron
Iron dextran solution 5% *7.***2.5mgFe/ml
Iron dextran solution *0% *5.****5.0mgFe/ml
Iron dextran solution *5% **2.****7.5mgFe/ml
Iron dextran solution *0% **0.****0.0mgFe/ml
Iron dextran powder *5%         >*5.0%
Iron dextran powder *0%         *8%**2%
Iron dextran powder *0%         >*8.0%

I.Description of products
1)Name:iron dextran *0%
Other name:Iron dextran complex,ferric dextranum,ferric dextran,iron complex
2)CAS NO:********4
3)Quality Standard:I.CVP***0 II.USP*4
4)Molecular formula:(C6H*0O5)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(LD*0) is ****0mg/kg,which belongs to the nontoxic degree.
II.Quality satandard:USP
PRODUCT NAME IRON DEXTRAN *0%
ASSAY:*0% (**0mg Fe/ml) BATCH NO.*******1
Spec:USP *2 MANUFACTURING DATE:*********1
REPORT DATE:Feb *8,  ***2 EXPIRY  DATE:*********0

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.*4
CHLORIDE             0.8%~1.1%                         1.0%
LIMIT OF PHENOL               <0.5%                  0.*5%<br /> BACTERIAL ENDOTOXINES       <0.*0 EU/mg Fe              COMPLIES WITH<br /> ACUTE TOXICITY            COMPLIES WITH               COMPLIES WITH
CONTENT OF IRON            *5.0~**5.0mgFe/ml                *8.1mgFe/ml
REMARK:TEST ACUTE TOXICITY BACTERIAL ENDOTOXINES.IRON ABSORPTION AFTER STERILIZE THE PRODUCT.
CONCLUSION:COMPLIES WITH THE USP*2

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:**4±3 *0 or*0 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
*5L *0L **0L
*5L HDPE drum:Mean.*9**7**2cm,Weight:1.6KG 
*0L HDPE drum:Mean.*8**9cm,Weight:3KG 
**0L HDPE drum:Mean.*9**2cm,Weight:*0KG