Iron Sucrose Complex 5% API

Name of Product Iron Sucrose Complex 5%
CAS No 8047-67-4
Therapeutic use:- Iron Salts
Grade BP/USP
Form:- API Powder
Status Commercial

Product Overview

Iron Sucrose Complex 5% is a pure ingredient that comes as a dark brown liquid or fine powder.

It is widely used in pharmaceutical manufacturing to support iron restoration applications.

The liquid API format improves solubility. It speeds up processing and simplifies formulation.

This suits large-scale production with consistent quality.  

Therapeutic Applications

Iron Sucrose Complex 5% API is used to make sterile parenteral formulations with iron.

It comes as a water-based complex ideal for developing intravenous products.

This API is for processes needing controlled iron content, high purity, and stable production on a large scale.

Specification Parameters

These parameters define the quality, purity, and consistency standards for the 5% iron sucrose complex API.

  • Chemical name (IUPAC): Iron(III) hydroxide–sucrose complex

  • CAS Number: 8047-67-4

  • Molecular formula: C₁₂H₂₉Fe₅Na₂O₂₃

  • Physical form: Dark brown powder or brown to dark brown solution

  • Identification tests: Positive tests for ferric ion, Positive tests for sucrose (HPLC-based)

  • Assay method: Iron by ICP/AAS; sucrose by HPLC or polarimetry.

  • Related substances (impurities): free sucrose, low-molecular-weight iron complexes, organic acids

  • Residual solvents: Comply with ICH Q3C limits (GC method)

  • Elemental impurities: Comply with ICH Q3D rules for heavy metals.

  • Loss on drying/water content: Not more than 5.0% w/w

  • pH (solution): Within the specified alkaline range.

  • Solubility: Completely miscible in purified water.

  • Microbial limits: Within pharmacopeial limits or not applicable for API grade.

      Packaging & Storage

      Iron Sucrose Complex 5% API is packed in specially sealed HDPE or fiber drums with two inner liners that keep moisture out.

      For smaller quantities, compatible containers can be used.

      Store the API in a place with steady room temperature.

      Keep it away from light and heat, and not close to freezing. This keeps it stable and functioning well.

      Why Choose Us

      Actiza Pharmaceutical Pvt. Ltd. delivers high-quality APIs that you can trust.

      Our experience and compliance enable us to provide global supply solutions.

      Global Reach

      We supplies Iron Sucrose Complex 5% API to over 40 countries worldwide.

      We work with more than 500 clients globally. We quickly deliver items to their destinations and handle regulations in different markets.

      Proven Experience

      Actiza Pharmaceutical Pvt. Ltd. has over 12 years of experience and offers reliable API sourcing options.

      We have a solid understanding of the process and have quality systems in place at every stage of production and supply.

      Quality Compliance

      We follow strong guidelines from WHO-GMP and ISO in our API operations.

      Audits and clear documents help us stay focused.

      Our processes are well-organised, so you can rely on our Iron Sucrose APIs to be pure and consistent during regulatory reviews.

      Wide Portfolio

      We Have a huge range of over 2000 product lines at the ready.

      We’ve got you covered with great technical support, flexible ordering, and full API solutions for diverse needs worldwide.