Ferric Carboxymaltose is an intravenous iron replacement active pharmaceutical ingredient used for the treatment of iron deficiency and iron deficiency anemia in appropriate clinical settings. It is a stable iron-carbohydrate complex designed to deliver iron for replenishment of body iron stores.
Ferric Carboxymaltose is identified by CAS Number 9007-72-1. Unlike conventional small-molecule APIs, Ferric Carboxymaltose is a complex macromolecular iron-carbohydrate preparation, so its characterization and quality control differ from those of conventional low-molecular-weight drug substances.
Ferric Carboxymaltose consists of an iron-containing carbohydrate complex in which iron is associated with a carboxymaltose carbohydrate ligand. Following intravenous administration, iron is gradually made available for incorporation into physiological iron-utilization pathways.
It is used in pharmaceutical formulations intended for intravenous iron replacement, particularly when oral iron is ineffective, poorly tolerated or when rapid iron replenishment is clinically appropriate.
Ferric Carboxymaltose provides iron for physiological utilization. The supplied iron is incorporated into hemoglobin and other iron-containing proteins after processing and utilization by the body's iron-handling pathways.
Replenishment of iron stores supports erythropoiesis and hemoglobin synthesis in patients with iron deficiency.
Ferric Carboxymaltose is used in pharmaceutical products for the treatment of iron deficiency and iron deficiency anemia in appropriate patient populations.
Depending on the applicable regulatory authorization, it may be used where:
The exact indication, dosage and administration requirements should follow the approved product labeling in the relevant market.
| 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) | 5.5 – 6.5 |
| Individual Impurity | NMT 0.5% |
| Total Impurities | NMT 1.0% |
| Water Content | NMT 1.0% |
| Melting Point | 150°C – 154°C |