Back to Catalog
Pharmaceutical Chemistry
Iron Carboxymaltose
Formula:
Комплекс гидроксида железа (III) с карбоксимальтозой
GOST/CAS:
9007-72-1 / 1417240-62-0
Iron Carboxymaltose (a highly effective non-dextran complex of trivalent iron) is a specialized pharmaceutical component (Active Pharmaceutical Ingredient, API) that acts as a key agent for the rapid and safe correction of iron deficiency in the body. The product is a colloidal complex in which the polynuclear iron (III) hydroxide core is surrounded by a carbohydrate ligand. It exhibits excellent solubility in water. Due to its stable structure, the complex releases iron slowly, minimizing the risk of toxicity and ensuring high bioavailability, making it indispensable for the manufacture of injectable dosage forms.
Applications
Prescription Medicine Production: Used as the primary active substance (API) in the manufacture of solutions for intravenous administration and infusions.
Anti-Anemic Therapy: Applied in creating formulations for the emergency correction of moderate-to-severe iron deficiency anemia (IDA) when oral iron intake is ineffective or impossible.
Hospital Segment: Dosage forms based on this substance are highly demanded in gastroenterology, nephrology (for CKD), obstetrics & gynecology, and cardiology (for CHF).
Pharmaceutical R&D: Utilized in research and development laboratories for generic formulation design and optimizing the stability of liquid injectable forms.
Key Advantages
High Stability and Safety: Low toxicity due to the robust binding of iron within the carboxymaltose shell, preventing an excess of free (toxic) iron in the blood serum.
Excellent Solubility: Physico-chemical properties are optimized for creating highly concentrated solutions, allowing for the administration of large doses of iron in a single infusion.
Physiological pH and Osmolarity: The complex easily adapts to parenteral medium standards, reducing the risk of local reactions (such as phlebitis) upon administration of the finished medicine.
Dextran-Free: Does not induce severe anaphylactic reactions commonly associated with older generations of injectable iron complexes (dextran-based).
Storage & Transportation
- Store in dry, cool, and well-ventilated warehouses designated for API storage, in tightly closed original packaging, away from heat sources.
- Recommended temperature range: +15°C to +25°C (protected from light). Do not freeze if supplied as a liquid concentrate.
- Avoid direct sunlight and exposure to moisture (the product is hygroscopic).
- Transportation is permitted by all modes of covered transport in strict compliance with the temperature regime. The substance is not classified as a dangerous good (no ADR / Class 9 hazard).
Technical Specifications
Appearance
Dark brown to reddish-brown amorphous powder
Molecular Weight
150,000 - 160,000 g/mol (high-molecular-weight complex)
Iron Content
24.0% - 32.0% (calculated on dried substance)
Solubility
Freely soluble in water, practically insoluble in ethanol
pH (10% aqueous solution)
5.0 – 7.0
Arsenic / Heavy Metals Content
Complies with Pharmacopoeia monographs / API purity grade
Supply info
- Specialized double-layer high-density polyethylene bags of 1 kg, 5 kg, or 10 kg, placed inside sealed aluminum bags or plastic/fibre pharmaceutical drums (25 kg drums for large wholesale batches).
- Each batch is accompanied by a Certificate of Analysis (CoA), Material Safety Data Sheet (MSDS), and DMF (Drug Master File) / CEP documentation.