Iron Dextran is a parenteral iron preparation consisting of a complex of ferric hydroxide with dextran. It is used as an iron-replacement agent for the management of iron deficiency when oral iron therapy is inadequate, not tolerated, or when parenteral iron administration is clinically required. Iron dextran is classified as a parenteral iron complex and provides iron in a form designed for controlled delivery to the body's iron-storage and utilization pathways.
Iron dextran is a colloidal iron-carbohydrate complex in which a polynuclear ferric oxyhydroxide core is associated with dextran chains. Unlike a simple low-molecular-weight chemical compound, iron dextran is a complex substance and therefore does not have a single conventional molecular weight in the same way as a small-molecule API. Published characterization describes iron dextran as a ferric hydroxide–dextran complex, with the molecular structure dependent on the complex composition.
The substance is identified by CAS Number 9004-66-4 and is also described as ferric hydroxide dextran complex, iron-dextran complex, ferric dextran, and iron (ferric hydroxide dextran complex). FDA's Global Substance Registration System lists Iron Dextran under these names and assigns the substance UNII 95HR524N2M.
Iron dextran is generally supplied as an aqueous colloidal preparation for pharmaceutical use. Depending on the specific pharmaceutical product, it may be formulated at a defined elemental iron concentration. Pharmaceutical iron dextran preparations are intended for parenteral administration and require appropriate quality control for iron content, identity, purity, physical characteristics, and microbiological quality.
The chemical formula commonly reported for iron dextran is (C₆H₁₀O₅)n·[Fe(OH)₃]m. Because the substance is a polymeric coordination complex rather than a single defined molecule, a conventional fixed molecular weight is not generally applicable. EFSA characterizes iron dextran with an approximate molecular-weight range of 4,000–6,000 Da for the characterized material.
Iron dextran is primarily associated with the treatment of iron deficiency and iron-deficiency anemia through parenteral iron replacement. Its pharmaceutical application is particularly relevant where rapid or reliable iron supplementation is required and oral administration is unsuitable.
Iron dextran is recognized in pharmaceutical and regulatory substance databases, including FDA's GSRS and PubChem.
Iron dextran is used as a source of parenteral iron in pharmaceutical preparations. It may be used when iron replacement is clinically necessary and oral iron is insufficient or unsuitable. Pharmaceutical formulations are standardized according to their elemental iron content, rather than treating the entire iron-dextran complex as a simple molecular entity.
Iron dextran pharmaceutical material should be stored according to the applicable manufacturer specification and pharmaceutical product requirements. Appropriate controls should be maintained during manufacturing, packaging, transportation, and storage to preserve product quality and stability.
For pharmaceutical manufacturing, testing should be performed according to the applicable pharmacopoeial monograph, approved specification, and regulatory requirements for the particular grade and formulation.
| Parameter | Specification |
|---|---|
| Appearance | White to off-white crystalline powder |
| Identification | IR & HPLC compliant |
| Assay (HPLC) | 98.0% – 102.0% |
| Loss on Drying | NMT 1.0% |
| Residue on Ignition | NMT 0.5% |
| pH (1% Solution) | 5.2–6.5 |
| Individual Impurity | NMT 0.5% |
| Total Impurities | NMT 1.0% |
| Water Content | NMT 1.0% |