| Specification |
|
| Name |
Iron Sucrose |
| Description |
Brown to dark brown powder |
| Identification for Ferric Iron |
Should respond Positive to Ferric Iron test |
| Identification for Sucrose by HPLC Retention time |
Should Comply |
| Weight Average Molecular
Weight, Daltons by Gel Permeation Chromatography |
NLT 34000 and NMT 60000 |
| Number Average Molecular
Weight, Daltons by Gel Permeation Chromatography |
NLT 24000 |
| Polydispersity Index |
NMT 1.7 |
| Limit test for Insoluble matter in water (%w/w) |
NMT 0.005 |
| pH at 25°C |
Between 9.0 and 11.0 |
| Osmolarity (mOsm perL) |
NLT 115 and NMT 135 |
| Turbidity pH |
NLT 4.4 and NMT 5.3 |
| Chloride Content(%w/w) |
NLT 0.035 and NMT 0.076 |
| Limit of Iron(II) by
Potentiometric redox titration (%w/w) |
NMT 1.0 |
| Absence of low molecular
weight Fe(II) and Fe(III) complexes by Polarography |
Any additional peak should not be
found in the Polarogram |
| Limit of residual Methanol by GC-HS (ppm) |
NMT 3000 |
| Assay of Sucrose by HPLC (%w/w) |
NLT 79.0 and NMT 91.0 |
| Assay of Iron by AAS on anhydrous basis (%w/w) |
NLT 4.8 and NMT 5.7 |
| Water by KF (%w/w) |
NMT 5.0 |
| Specific Gravity at20°C |
NLT 1.135 and NMT 1.165 |
| Bulk density (g/mL) |
NLT 0.45 and NMT 0.75 |
| Tapped density (g/mL) |
NLT 0.85 and NMT 1.15 |
| Particle size distribution by Malvern (wet method) |
90% of the particles should be less than 150µm |
| Microbial Tests |
|
| Bacterial endotoxin by Gel clot technique (EU/g) |
NMT 160 |
| Limit of total combined
molds and yeasts count (cfu/g) |
NMT 100 |
| Total microbial count |
NMT 100 |
| Limit test for
Staphylococcus aureus and Pseudomonas aeruginosa |
Should be absent |
| Limit test for Salmonella species and Escherichia coli |
Should be absent |
