Ferumoxytol is an intravenous iron replacement pharmaceutical ingredient used for the treatment of iron deficiency anemia in appropriate clinical settings. It is an iron-carbohydrate complex containing a superparamagnetic iron oxide core surrounded by a carbohydrate coating.
Ferumoxytol provides iron for physiological utilization and helps replenish depleted iron stores. It is particularly associated with intravenous iron replacement when oral iron therapy is ineffective, poorly tolerated, or otherwise unsuitable.
Ferumoxytol is a complex iron-containing pharmaceutical preparation rather than a conventional low-molecular-weight API. Its pharmaceutical characteristics are therefore evaluated using specialized physicochemical and quality attributes.
Following intravenous administration, the iron contained in Ferumoxytol becomes available for physiological utilization, supporting hemoglobin synthesis and erythropoiesis.
Ferumoxytol provides a source of iron that is processed through the body's normal iron-handling pathways. The released iron can be incorporated into hemoglobin, myoglobin and iron-containing enzymes.
Replenishment of iron stores supports red blood cell production and helps correct iron deficiency.
Ferumoxytol is associated with pharmaceutical applications for:
The specific indication and administration requirements should be based on the applicable approved product labeling.
Ferumoxytol is an iron oxide–carbohydrate nanoparticle complex. Because it is a complex pharmaceutical material, it does not have a single conventional molecular formula or molecular weight comparable to small-molecule APIs.
For this reason, important quality characteristics can include total iron content, particle-size distribution, complex integrity, free iron, pH and other physicochemical properties.
Pharmaceutical-grade Ferumoxytol should be manufactured and tested according to applicable pharmaceutical quality and regulatory requirements. Depending on the supplied material, quality documentation may include:
Ferumoxytol should be stored in a tightly closed container under the manufacturer's recommended storage conditions and protected from unsuitable temperature, light and contamination. The validated storage conditions for the specific material should always be followed.
| 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% |
| Heavy Metals | NMT 20 ppm |
| pH (1% Solution) | 2.0 – 4.0 |
| Individual Impurity | NMT 0.5% |