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Pharmaceutical Chemistry
Iron(III) hydroxide polymaltose complex
GOST/CAS:
CAS 9004-66-4
Iron(III) hydroxide polymaltose complex is a highly effective Active Pharmaceutical Ingredient (API) consisting of a stable macromolecular complex of trivalent iron and partially hydrolyzed dextrin (polymaltose). The structural core of this complex is highly analogous to ferritin, the naturally occurring iron-storage protein in the human body. Due to this structure, the product features excellent bioavailability, lacks pro-oxidant properties, and does not cause mucosal irritation in the gastrointestinal tract, making it an ideal component for manufacturing advanced antianemic medications.
Applications
Production of Liquid Oral Dosage Forms: Utilized as the primary active ingredient in the formulation of syrups, oral drops, and drinkable solutions. Its excellent water solubility ensures the production of stable, homogeneous systems without sediment.
Production of Solid Dosage Forms: Applied in the manufacturing of chewable tablets, film-coated tablets, and capsules. The powder form's physical stability ensures accurate dosing and excellent processability during compression and encapsulation.
Pediatric Pharmaceuticals and Nutriceuticals: Widely utilized in pediatric formulations and specialized vitamin-mineral complexes for pregnant and lactating women due to its high safety profile and absence of a metallic aftertaste.
Veterinary Medicine and Premixes: Used in the production of premium veterinary drugs and feed additives intended for the prevention and treatment of iron deficiency anemia in livestock and domestic animals.
Key Advantages
Superior Safety and Tolerability: Unlike simple ferrous salts (Fe), this complex does not release free iron ions in the gastrointestinal tract. This minimizes typical side effects such as nausea, constipation, and tooth enamel staining.
Physiological Absorption Mechanism: Iron is absorbed from the complex via an active transport mechanism resembling natural ferritin absorption. The risk of accidental overdose is virtually nonexistent, as absorption rates automatically decrease as the body's iron levels normalize.
Technological and Chemical Stability: The complex remains stable across a wide pH range and does not interact with dietary components (such as phytins or oxalates) or other pharmaceutical excipients, preserving the finished product's integrity throughout its shelf life.
Excellent Organoleptic Properties: The polymaltose shell effectively masks the unpleasant metallic taste of iron. This greatly simplifies the development of pleasant flavor profiles for pediatric syrups and chewable tablets.
Storage & Transportation
- Store in a dry, dark, and well-ventilated warehouse in original, tightly sealed packaging.
- Recommended storage temperature: +15°C to +25°C (avoid temperature fluctuations and prevent freezing for liquid concentrates).
- Protect from direct sunlight and moisture exposure.
- Transportation is permitted by all modes of covered transport in strict compliance with temperature-controlled shipping regulations. The material is not classified as a dangerous good (ADR classification is not applicable).
- Shelf Life: 3 years from the date of manufacture (provided that the integrity of the original packaging is maintained).
Technical Specifications
Appearance
Amorphous powder, red-brown to dark brown in color.
Molecular Weight
100,000 - 150,000 g/mol (high molecular weight complex).
Iron Content (Fe³⁺)
25.0% - 35.0% (calculated on the dried basis, depending on specification).
Solubility
Freely soluble in water, forming a colloidal solution; practically insoluble in ethanol and organic solvents.
pH (10% aqueous solution)
5.0 - 7.0
Supply info
- The powder bulk substance is supplied in airtight double polyethylene bags inside fiber or plastic pharmaceutical drums with a net weight of 25 kg.
- For liquid intermediates or concentrates, delivery in plastic jerricans or IBC totes is available upon individual request.