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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 suppliers must adhere to strict ferrous fumarate specifications and provide a Certificate of Analysis (COA). This article outlines the key parameters for ferrous fumarate compliance.

Ferrous Fumarate Specification Overview
Ferrous fumarate (C₄H₂FeO₄) must meet pharmacopeial standards such as USP, BP, or EP. Key specifications include:
– Assay (Purity): ≥97.0% to 101.0%
– Iron Content: 32.5% to 33.5%
– Loss on Drying: ≤1.5%
– Sulfate Ash: ≤0.2%
– Heavy Metals (Pb, As, Cd, Hg): ≤10 ppm
– Residual Solvents: Meets ICH guidelines

Certificate of Analysis (COA) Requirements
A COA verifies compliance with specifications and includes:
1. Physical Properties: Appearance (reddish-brown powder), solubility, and particle size.
2. Chemical Analysis: HPLC/UV results confirming purity and iron content.
3. Microbial Limits: Total aerobic count ≤1000 CFU/g, absence of pathogens.
4. Impurity Profile: Limits for fumaric acid, ferric iron, and other by-products.

Why COA Matters for Buyers
A valid COA ensures:
– Regulatory Compliance (FDA, EMA, WHO)
– Batch-to-Batch Consistency
– Safety & Efficacy for pharmaceutical/nutraceutical use

Conclusion
When sourcing ferrous fumarate, always request a detailed COA and verify specifications against pharmacopeial standards. This guarantees product quality, regulatory approval, and optimal performance in end applications.

For high-purity ferrous fumarate with certified COAs, partner with trusted suppliers adhering to GMP and ISO standards.