Iron Sucrose

Product Name:Iron Sucrose
Product Formula:[Na2 (FeOOH) 5(OH) 2 .x (H2O)] n. m(C12H22O11)
Molecular Weight:
CAS Number:
No. Tests Specifications Reference
1 Description Dark brown to reddish brown homogenous
powder, almost odorless, sweet in taste and
hygroscopic.
2 Identification
A. Test for Iron
B. Test for Sucrose
C. By Gel permeation Chromatography
- Weight average Molecular Weight (MW)
- Number Average Molecular Weight (MN)
- Polydispersity Index (MW / MN)

Shall pass the test
Shall pass the test


Between 34,000 and 60,000 Da

Not less than 24,000 Da

Not more than 1.7

USP*
USP*


USP*
3 Specific gravity (2% w/v of Fe) Between 1.135 and 1.165 USP*
4 pH (2% w/v of Fe) 9.5 to 11.0 USP*
5 Chloride content (9g/g of Iron Sucrose) Between 335 ppm and 600 ppm USP*
6 Water Content by Karl Fischer (w/w) Not more than 5.0% Ph. Eur.
7 Turbidity pH Between 4.4 and 5.3 USP*
8 Absence of low molecular weight Fe(II) and
Fe(III) complexes by Polarography
No additional peaks to be found in the
polarograms obtained in the test for limit of Fe(II)
USP*
9 Limit of Fe (II) by Polarography (w/w) Not more than 1.0% USP*
10 Assay of Iron (w/w) on anhydrous basis by
AAS
Between 4.8% and 6.4 % USP*
11 Assay of Sucrose (w/w) by HPLC Between 79.0 % and 91.0 % USP*
12 Microbiological limits
13 Total Bacterial Count Not more than 500cfu/g Ph. Eur.
14 Total Yeast and Mould Not more than 100cfu /g Ph. Eur.
15 Bacterial Endotoxin Not more than 100 EU/g Ph. Eur.
16 Additional Tests
17 Cadmium by AAS Not more than 5 ppm In-house method
18 Lead by AAS Not more than 5 ppm In-house method
19 Arsenic by AAS Not more than 3 ppm In-house method

* Test procedures adopted from the monograph of Iron Sucrose Injection USP


Storage: Recommended to store in a well-closed container, protected from direct sunlight and moisture.


Retest Period: 2 years from the date of manufacture


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