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Ferrous Fumarate Specification and COA: Key Quality Parameters

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 rely on detailed specifications and Certificates of Analysis (COA). Below is an overview of critical parameters for ferrous fumarate specification and COA compliance.

Ferrous Fumarate Specification
1. Chemical Formula: C₄H₂FeO₄
2. Appearance: Reddish-brown or orange-brown powder
3. Assay (Purity): ≥97.0% (as anhydrous basis)
4. Iron (Fe) Content: 32.5–33.5%
5. Loss on Drying: ≤1.5% (105°C, 2 hours)
6. Residue on Ignition: ≤0.1%
7. Heavy Metals: ≤20 ppm (as Pb)
8. Arsenic (As): ≤3 ppm
9. Lead (Pb): ≤10 ppm
10. Microbial Limits:
– Total Plate Count: ≤1,000 CFU/g
– Yeast & Mold: ≤100 CFU/g
– Absence of E. coli, Salmonella, and Staphylococcus aureus

Certificate of Analysis (COA) Requirements
A COA for ferrous fumarate verifies compliance with pharmacopeial standards (USP, EP, or BP). Key COA components include:
– Batch Number & Manufacturing Date
– Expiry Date
– Test Methods (HPLC, titration, ICP-MS)
– Test Results (matching specifications)
– Regulatory Compliance (GMP, ISO certification)

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– Ferrous fumarate USP grade
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Conclusion
Ferrous fumarate must meet strict specifications to ensure safety and efficacy. A COA provides transparency, confirming adherence to industry standards. Buyers should always request COAs to verify quality before procurement.