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Ferrous Fumarate Specification and Certificate of Analysis (COA) Guide

Ferrous fumarate is a widely used iron supplement known for its high bioavailability and effectiveness in treating iron deficiency anemia. Understanding its specification and Certificate of Analysis (COA) is crucial for manufacturers, suppliers, and regulatory compliance.

Ferrous Fumarate Specification
Ferrous fumarate must meet strict quality standards to ensure safety and efficacy. Key specifications include:
– Chemical Formula: C₄H₂FeO₄
– Appearance: Reddish-brown or orange-brown powder
– Assay (Purity): ≥97.0% (USP/EP standards)
– Iron Content: 32.5–35.0%
– Loss on Drying: ≤1.5%
– Residue on Ignition: ≤0.1%
– Heavy Metals: ≤20 ppm (as per USP)
– Arsenic: ≤3 ppm
– Microbial Limits: Complies with USP/EP requirements

Certificate of Analysis (COA) for Ferrous Fumarate
A COA is a critical document verifying that the product meets specified standards. A typical COA includes:
1. Product Identification – Name, batch number, and manufacturing date.
2. Test Parameters – Assay, iron content, moisture, heavy metals, and microbial limits.
3. Test Methods – References to USP, EP, or in-house validated methods.
4. Results – Actual values vs. specification limits.
5. Compliance Statement – Confirmation of adherence to regulatory standards.

Why COA Matters
– Ensures product quality and safety.
– Required for regulatory submissions (FDA, EMA, etc.).
– Builds trust between suppliers and buyers.

For reliable sourcing, always request a COA from your ferrous fumarate supplier. This guarantees compliance with pharmaceutical and nutraceutical industry standards.

By adhering to these specifications and verifying COA documentation, businesses can ensure high-quality ferrous fumarate for supplements and medical applications.