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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 safety and efficacy, manufacturers and suppliers must provide a detailed ferrous fumarate specification along with a Certificate of Analysis (COA). This article outlines the essential parameters and compliance standards for ferrous fumarate.

Ferrous Fumarate Specification
Ferrous fumarate must meet strict quality criteria, including:
– Chemical Formula: C₄H₂FeO₄
– Assay (Purity): ≥93.0% to 100.5%
– Iron Content: 32.5% to 33.0%
– Loss on Drying: ≤1.5%
– Residue on Ignition: ≤0.2%
– Heavy Metals (as Pb): ≤20 ppm
– Arsenic (As): ≤3 ppm
– Microbial Limits: Complies with USP/EP standards

Certificate of Analysis (COA) Requirements
A COA verifies that the ferrous fumarate batch meets regulatory standards. Key components include:
– Batch/Lot Number for traceability
– Manufacturing Date & Expiry
– Test Results (assay, heavy metals, microbial limits)
– Compliance Reference (USP, EP, or BP)
– Authorized Signatory for validation

Why Ferrous Fumarate Quality Matters
High-purity ferrous fumarate ensures optimal absorption and minimizes side effects. Buyers should always request a ferrous fumarate COA to confirm compliance with pharmacopeial standards (USP, EP, or BP).

For reliable sourcing, partner with GMP-certified suppliers who provide transparent ferrous fumarate specifications and COAs. This guarantees product safety, regulatory compliance, and therapeutic effectiveness.

By prioritizing quality documentation, businesses and healthcare providers can ensure superior ferrous fumarate products for better health outcomes.