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Ferrous Fumarate Specification and COA: Key Quality Parameters

Ferrous fumarate is a widely used iron supplement in pharmaceuticals and food fortification. Ensuring its quality requires strict adherence to specifications and a Certificate of Analysis (COA). This article outlines the critical parameters for ferrous fumarate specification and COA to meet industry standards.

Ferrous Fumarate Specification
1. Chemical Formula & Molecular Weight:
– Formula: C₄H₂FeO₄
– Molecular Weight: 169.9 g/mol

2. Appearance:
– Reddish-orange to brown powder

3. Assay (Purity):
– Minimum 97.0% ferrous fumarate (anhydrous basis)

4. Iron Content:
– 32.5–33.5% (w/w)

5. Loss on Drying:
– ≤1.5% (105°C, 3 hours)

6. Residue on Ignition:
– ≤0.2%

7. Heavy Metals:
– ≤20 ppm (as Pb)

8. Arsenic (As):
– ≤3 ppm

9. Microbial Limits:
– Total aerobic count: ≤1000 CFU/g
– Yeast & mold: ≤100 CFU/g
– Absence of E. coli and Salmonella

Certificate of Analysis (COA) Requirements
A COA for ferrous fumarate must include:
– Batch/Lot Number: For traceability
– Manufacturing & Expiry Date: Ensures shelf-life compliance
– Test Results: Confirming assay, iron content, heavy metals, etc.
– Compliance Statement: Meets USP/EP/BP or other pharmacopeial standards
– Authorized Signatory: Validates authenticity

Why Quality Matters
Ferrous fumarate must meet strict specifications to ensure efficacy and safety in supplements and medications. A detailed COA guarantees regulatory compliance and consumer trust.

For manufacturers and suppliers, adhering to these standards ensures product reliability and market competitiveness. Always verify COAs before procurement to maintain quality control.

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