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Ferrous Fumarate Specification and COA: Key Details for Quality Assurance

Ferrous fumarate is a widely used iron supplement known for its high bioavailability and effectiveness in treating iron deficiency anemia. To ensure product quality, manufacturers and buyers must adhere to strict ferrous fumarate specifications and review the Certificate of Analysis (COA) before procurement.

Ferrous Fumarate Specification Overview
Ferrous fumarate must meet pharmacopeial standards (USP, BP, or EP) for purity, potency, and safety. Key specifications include:
– Assay (Purity): ≥97.0% – 101.0% ferrous fumarate (C₄H₂FeO₄)
– Iron Content: 32.5% – 33.5% (as Fe²⁺)
– Loss on Drying: ≤1.5%
– Sulfate (SO₄): ≤0.2%
– Heavy Metals (as Pb): ≤20 ppm
– Arsenic (As): ≤3 ppm
– Microbial Limits: Complies with USP/EP requirements

Importance of COA for Ferrous Fumarate
A Certificate of Analysis (COA) is a critical document verifying that the product meets the stated specifications. It includes:
– Batch/Lot Number for traceability
– Manufacturing & Expiry Dates
– Test Results (HPLC, titration, ICP-MS) confirming purity and contaminants
– Regulatory Compliance (USP, BP, EP, or other standards)

Why Compliance Matters
Adhering to ferrous fumarate specifications ensures:
– Safety – Low heavy metal and microbial contamination
– Efficacy – Proper iron content for therapeutic use
– Regulatory Approval – Compliance with FDA, EMA, and other agencies

Conclusion
When sourcing ferrous fumarate, always verify the COA and confirm that the product meets pharmacopeial specifications. This guarantees quality, safety, and regulatory compliance for pharmaceutical and supplement applications.