Product Overview
Ferric Carboxymaltose API is a stable iron-carbohydrate complex with a high molecular structure.
It contains ferric iron bound to carboxymaltose polymers, allowing controlled iron availability.
The API is stable, low-reactive, and highly compatible.
This makes it suitable for the formulation of injectable products.
Therapeutic Applications
Ferric Carboxymaltose API is used in formulations designed to manage iron deficiency across many clinical areas.
It makes formulations to replace iron in people with anemia.
This can be due to kidney issues, heart conditions, pregnancy, or other health problems like digestive issues or surgery.
The API provides quick iron availability when oral absorption is poor or not effective.
Specification Parameters
Ferric Carboxymaltose API sets vital quality and performance standards.
They ensure safe use and support consistent results in formulation.
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Appearance: A brown, shapeless solid or dark brown colloid, with no visible impurities.
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CAS Number: 9007-72-1
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Chemical Name (IUPAC): Polymeric iron(III)-hydroxide complex stabilized with carboxymaltose
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Assay Method: Total iron by Atomic Absorption Spectrometry or potentiometric titration; carbohydrate content by HPLC
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Solubility: Easily soluble in water; not soluble in common organic solvents.
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pH range: Kept close to neutral for stability and compatibility.
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Related Substances / Impurities: Unreacted or oxidized maltodextrins, inorganic salts, free iron ions, and high-molecular-weight fractions controlled within limits
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Ferrous iron: has very low Fe²⁺ content, staying within strict limits.
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Carbohydrate Level: The amount of dextrin or carbohydrates is managed to ensure the complex stays stable.
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Residual Solvents: Methanol and acetone, if used, are controlled as per ICH Q3C guidelines
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Elemental Impurities: Controlled according to ICH Q3D requirements for use
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Endotoxins: Stay within set limits for high purity and safety.
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Loss on Drying / Water Content: Limited to specified levels to maintain stability and quality
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Identification Tests: Confirmed by iron reaction tests, carbohydrate identification, and chromatographic methods
Packaging & Storage
Ferric Carboxymaltose API should be stored at controlled room temperature.
Keep this between 20°C and 25°C for best results. It can tolerate up to 30°C for short times.
Store it in tightly sealed, light-protected HDPE or fiber drums with inner polyethylene liners.
Make sure that the place where you store it is clean and dry area, and well-ventilated.
Do not expose the product to dampness, heat, or direct sunlight.
Why Choose Us
Actiza Industry provides Ferric Carboxymaltose. We focus on quality and use modern facilities.
Our reliable support helps partners grow safely and smoothly worldwide.
Advanced Facilities
We have a fully automated plant with a clean area and a strict control system.
All stages adhere to international standards.
This means safety, quality, and efficiency are assured for each batch of Ferric Carboxymaltose.
Strong Quality
The quality of the product is being tested before release and after packing as well.
Our staff are especially trained in WHO-GMP and ISO standards, ensuring the safety, quality, and regulatory compliance of each batch.
Reliable Supply
With a self-sustaining API and a strong vendor network, we ensure raw materials and timely deliveries.
This is a great way for partners to escape delays and keep their business flowing across markets.
Customer Support
We offer clear communication, easy order sizes, fair prices, and timely delivery.
Our customer service team works across various time zones.
This means they’re always available to offer quick support and keep you updated on your order status during the entire manufacturing process.
