Iron Sucrose is an intravenous iron replacement complex consisting of polynuclear iron(III)-oxyhydroxide cores stabilized by sucrose molecules. It is used to replenish iron stores and support hemoglobin synthesis in patients with iron deficiency, particularly when oral iron is ineffective, not tolerated, or when intravenous iron replacement is clinically appropriate.
Iron Sucrose is supplied as a sterile injectable preparation and is commonly expressed in terms of elemental iron concentration.
Iron Sucrose is a specialized iron-carbohydrate complex pharmaceutical ingredient manufactured under controlled conditions. Its quality assessment differs from conventional small-molecule APIs because the product is a complex colloidal iron-carbohydrate system.
Critical quality attributes include iron content, identification, physicochemical characteristics, particle-size distribution, iron release characteristics, sucrose content, pH, endotoxins, microbial quality and stability.
CAS Number: 8047-67-4
Molecular Formula: Variable / complex
Molecular Weight: Variable
Drug Class: Iron Replacement Product
Pharmacological Class: Parenteral Iron Preparation
Therapeutic Class: Hematinic / Iron Supplement
Therapeutic Area: Hematology / Nephrology
Iron Sucrose consists of a polynuclear iron(III)-oxyhydroxide core surrounded and stabilized by sucrose molecules.
The complex is designed to provide iron for incorporation into hemoglobin and iron-containing proteins following intravenous administration.
After intravenous administration, Iron Sucrose is taken up by cells of the reticuloendothelial system. Iron is subsequently released from the complex and made available for physiological iron metabolism.
The released iron contributes to:
Iron Sucrose is used for treatment of iron deficiency and iron-deficiency anemia, including in patients with chronic kidney disease where intravenous iron replacement may be required.
Applications can include:
Specific approved indications depend on the formulation and applicable regulatory authorization.
Typical manufacturing of Iron Sucrose may involve:
Iron Sucrose quality evaluation may include:
Iron Sucrose should be stored according to validated stability data and approved product requirements, generally protected from unsuitable temperatures and excessive light. The finished sterile injectable preparation should be maintained in its approved container system.
Iron Sucrose is relevant to research involving:
Iron Sucrose is a complex iron(III)-oxyhydroxide–sucrose preparation used for intravenous iron replacement. It has CAS Number 8047-67-4. Unlike conventional molecular APIs, Iron Sucrose has a complex/variable molecular structure and is therefore characterized using multiple physicochemical and biological quality attributes rather than a single defined molecular weight.
| Parameter | Specification |
|---|---|
| Appearance | White crystalline powder |
| Identification | IR & HPLC compliant |
| Assay (HPLC) | 95.0% – 105.0% |
| Loss on Drying | NMT 1.0% |
| Residue on Ignition | NMT 0.5% |
| Heavy Metals | NMT 10 ppm |
| pH (1% Solution) | 10.5 – 11.1 |
| Individual Impurity | NMT 0.5% |
| Total Impurities | NMT 1.0% |
| Water Content | NMT 1.0% |