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
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%
BACTERIAL ENDOTOXINES       ≤0.*0 EU/mg Fe              COMPLIES WITH
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

â…¢: Application:  It can be made into ferric injection through repack directly.
1.OPERATION DEMAND
â… . 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.
â…¡. Sterilization：**4±3℃ *0 or*0 minutes
â…¢. After refrigeration, wipe bottle and bottle cap clean and then test under light, remove the bottle which ullage, air leakage and have impurity.
â…£. After Labeling and packing to obtain finish products.
(For reference only)