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Ferric Carboxymaltose Injection API

Name of Product Ferric Carboxymaltose Injection
CAS No 9007-72-1
Therapeutic use:- Iron Salts
Grade BP/USP
Form:- API Powder
Status Commercial

Product Overview

Ferric carboxymaltose is an iron–carbohydrate active pharmaceutical ingredient (API).

It is a complex of polynuclear iron(III) hydroxide and a carboxymaltose ligand.

The material appears as a brown amorphous powder or a fine brown powder.

Each batch has a specific iron content and an impurity limit.

Production occurs under controlled conditions to ensure consistent quality.

We check particle form and the basic microbiological profile before releasing each batch.

Therapeutic Applications

Ferric carboxymaltose is used as an API in parenteral iron products.

These products sit in the hematology and nutrition segments.

In the finished product, it acts as a colloidal iron–carbohydrate complex for IV use.

Details such as indication, dose, and target group are set at the product level.

They are defined in the product dossier and by local rules, not at the API stage.

Specification Parameters

  • CAS Number: 9007-72-1

  • Chemical Name: Polynuclear iron(III) hydroxide–carboxymaltose complex

  • Molecular Nature: Macromolecular iron–carbohydrate complex (empirical formula available on request)

  • Appearance: Brown to dark brown powder

  • Solubility: Freely dispersible in water to form colloidal solutions.

  • Iron Content (on dried basis): typically 24.0 – 33.0 % w/w (specifiable range)

  • Carbohydrate (dextrin / carboxymaltose) Content: typically 25.0 – 50.0 % w/w (on dried basis)

  • pH (aqueous solution): usually 5.0 – 7.0 (as per specification)

  • Loss on Drying: ≤ 10.0 %

  • Elemental Impurities: Lead, cadmium, arsenic, nickel, and other elements within current guideline limits

    Packaging & Storage

    Ferric carboxymaltose grade is packed in sealed, light-protected containers.

    Common packs include HDPE bottles or drums and fibre drums with inner polyethylene or foil bags.

    Each container is clearly labelled with product name, batch number, net weight, manufacturing date, and retest or expiry date.

    The API should be stored in a cool, dry place. Keep it away from strong light, heat, and moisture to protect the quality.

    Why Choose Us

    We supply ferric carboxymaltose with a stable iron content and low impurity levels.

    You receive clear batch documents, including CoA, SDS, and basic technical data.

    We offer pack sizes suited to lab work, scale-up, and commercial manufacture.

    Our team answers technical and commercial queries quickly in simple language.

    We plan long-term supply, so your iron products do not face stock gaps.