Iron Sucrose Specification
|
ITEMS |
SPECIFICATION |
RESULTS |
|
Appearance |
Brown to dark brown powder |
Brown powder |
|
Identification |
A (Iron): Positive to USP test |
Conforms |
|
B(Sucrose): The retention time of the major peak in HPLC of the assay preparation corresponds to that in the chromatogram of the standard preparation under assay for sucrose |
Conforms |
|
|
Identification C (Molecular weight determination) |
Mw: 34,000 ~ 60,000 Da |
52075 |
|
Mn ≤ 24,000 Da |
36696 |
|
|
Mw/Mn ≤ 1.7 |
1.4 |
|
|
Identification D |
A280/A340: 1.40 ~ 1.55 |
1.47 |
|
A340/A420: 2.60 ~ 2.85 |
2.73 |
|
|
Specific gravity |
1.136 ~ 1.165 (20℃) |
1.149 |
|
PH |
10.5 ~ 11.1 (as injection) |
10.9 |
|
Osmclarity |
1150 ~ 1350 mOsmol/L |
1250 mOsmol/L |
|
Alkalinity |
Not less than 0.5 ml and not more than 0.8 ml of 0.1N Hydrochloric Acid VS is consumed per ml of injection |
0.7 ml/ml |
|
Fe(III) complexes |
Absent |
Absent |
|
Turbidity(pH) |
4.4 ~ 5.3 (as injection) |
4.7 |
|
Limit of Iron(II) |
≤ 0.4% (as injection) |
0.2% |
|
Content of Chloride |
0.012% ~ 0.025%(as injection) |
0.021% |
|
Ratio of Sucrose/Iron |
13.0 ~ 17.0 |
15.1 |
|
Loss on drying |
≤ 3.0% |
0.2% |
|
Heavy metals |
≤ 15 ppm |
< 15 ppm |
|
Arsenic |
≤ 2 ppm |
< 2 ppm |
|
Bacterial endotoxins |
≤ 1.0 EU/mg Iron |
Conforms |
|
Microbiological |
TAMC ≤ 100 CFU/gm |
< 1 CFU/gm |
|
TYMC ≤ 50CFU/gm |
< 1 CFU/gm |
|
|
Escherichia coli absent in 1g |
Absent |
|
|
Bacterial endotoxin |
≤ 1.0 IU/mg |
< 1.0 IU/mg |
|
Assay |
Sucrose:80.0% to 90.0% (on dried substance) |
84.0% |
|
Iron: 5.0% to 6.0% (on dried substance) |
5.6% |
|
|
Couclusion |
The above product conforms to USP36 standard. |
|
Usage
The indication of iron sucrose is used in the treatment of iron deficiency anemia in long-term hemodialysis patients who are supplementing erythropoietin
Packaging & Shipping
Iron Sucrose Packaging:
1kg/bag or according to client request
Iron Sucrose Delivery Detail:
1~2 weeks after confirm order.Some of the products can be supplied within 7 days on the strength of EDC warehouse.
Our Services
1. Exporting chemical products from China over 5 years of experience.
2. Arrange the orders and shipping with requests in time, According to the different countries export policy provide complete customs clearance documents..
3. Variety of high quality chemical products with competitive price
Company imformation:
Hubei Ipure chemical Co., Ltd. is Established in 2011,which is located in Wuhan We have decades of experience
The company is a diversified product production and operation enterprise, with API, pharma intermediates, and other fine chemicals as well as R&D and pigments development and sales as one of the large enterprises, with more than 130 acres of plant in accordance with GMP production requirements.
we also have a strong team of professional R&D technology.we have about 300 employees, including 90 full-time PHD 15 PHD and masters above, 153 undergraduates, with reasonable professional knowledge structure and adequate staffing.
The company has passed the ISO 9001 quality system certification. The products are exported to North America, South America, Europe, Australia Japan, Korea and other country . High quality products and good service are deeply trusted and praised by customers at home and abroad.
