Description

Ferric Carboxymaltose is a stable, polynuclear iron(III)-hydroxide carbohydrate complex designed for parenteral administration. This compound is critically important as a modern, efficient intravenous iron replacement therapy for treating iron deficiency. It is primarily needed by pharmaceutical manufacturers and compounding facilities within the global healthcare sector, where it serves as the active pharmaceutical ingredient (API) in injectable formulations.

Application

• Intravenous Iron Replacement Therapy: As the core API in injectable drugs for treating iron deficiency anemia (IDA) in patients who cannot tolerate or have an inadequate response to oral iron.
• Pharmaceutical Formulations: Used in the development and commercial production of sterile, ready-to-use injectable solutions and lyophilized powders.
• Chronic Kidney Disease (CKD) Management: A key therapeutic for managing anemia associated with chronic kidney disease, including patients on dialysis.
• Heart Failure with Iron Deficiency: Employed in specific therapeutic regimens for patients with chronic heart failure and concomitant iron deficiency.
• Inflammatory Bowel Disease (IBD): Used to correct iron deficiency in patients with Crohn's disease or ulcerative colitis where oral iron is ineffective or not tolerated.
• Gynecology & Obstetrics: Treatment of iron deficiency anemia in women with heavy menstrual bleeding or in the postpartum period.
• Oncological Supportive Care: Management of anemia in cancer patients, particularly those with chemotherapy-induced anemia.
• Research & Development: Serves as a reference standard and raw material for preclinical and clinical research into novel iron therapies and delivery systems.

Basic Information

Product Name	Ferric Carboxymaltose
CAS No.	9007-72-1
Molecular Formula	[Fex(OH)y(C12H22O11)z] (Complex Carbohydrate Polymer)
Molecular Weight	Contact for details (Complex polymeric structure)
Synonyms	Ferric Carboxymaltose; Iron(III) Hydroxide Carboxymaltose; Ferric Carboxymaltose Complex; FCM; Injectafer® (Brand Name); Ferinject® (Brand Name); Iron Sucrose Analog; Polynuclear Iron(III)-Hydroxide Carboxymaltose; IV Iron Carboxymaltose
EINECS	Contact for details

Quality Control

Our Ferric Carboxymaltose is manufactured under strict quality systems suitable for pharmaceutical applications. Quality assurance includes comprehensive testing against relevant pharmacopeial standards (e.g., USP, EP) for identity, purity, potency, and safety. Certificates of Analysis (COA) documenting batch-specific results for iron content, carbohydrate content, physicochemical properties, and microbiological quality are available upon request.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15°C and 25°C (59°F and 77°F). The product is hygroscopic; keep the container tightly sealed in a dry environment to prevent moisture absorption.

Specification

Item	Specification
Appearance	Brown to reddish-brown powder or solid mass
Identification (IR)	Conforms to standard
pH (Solution)	5.0 - 7.0
Assay (Iron Content)	Contact for details
Carboxymaltose Content	Contact for details
Free Iron	≤ Specified limit
Related Substances (HPLC)	Conforms to standard
Residual Solvents (GC)	Meets ICH guidelines
Heavy Metals	≤ 20 ppm
Bacterial Endotoxins	< Specified limit (EU/mL)
Sterility (for sterile grade)	Sterile

Note: Specifications can be tailored. Please contact us for the detailed technical data sheet of a specific grade.