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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. Understanding its specification and Certificate of Analysis (COA) is crucial for manufacturers, suppliers, and end-users to ensure product quality, safety, and compliance with regulatory standards.

Ferrous Fumarate Specification
Ferrous fumarate must meet strict chemical and physical criteria to be considered pharmaceutical or food-grade quality. Key specifications include:
– Chemical Formula: C₄H₂FeO₄
– Assay (Purity): ≥97.0% (typically 97-101%)
– Iron Content: 32.5-33.5% (as Fe²⁺)
– Loss on Drying (LOD): ≤1.0%
– Residue on Ignition (ROI): ≤0.1%
– Heavy Metals (as Pb): ≤20 ppm
– Arsenic (As): ≤3 ppm
– Particle Size: Varies based on application (e.g., fine powder for tablets)

These parameters ensure the product is free from contaminants and suitable for medical or nutritional use.

Certificate of Analysis (COA) for Ferrous Fumarate
A COA is a critical document provided by manufacturers to verify compliance with specifications. It includes:
– Batch/Lot Number for traceability
– Manufacturing and Expiry Dates
– Test Results (e.g., assay, heavy metals, microbial limits)
– Testing Methods (e.g., USP, EP, or in-house validated methods)
– Regulatory Compliance (e.g., FDA, WHO, or EU standards)

Why COA Matters
A valid COA ensures transparency, regulatory compliance, and product safety. Buyers should always request and review the COA before procurement to confirm the ferrous fumarate meets required standards.

For high-quality ferrous fumarate, always verify the specification and COA to guarantee efficacy and safety in your applications.