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
