Ferrous Malate
Ferrous Malate is an organic iron source formulated for dietary supplements, functional foods, and pharmaceutical preparations. By combining ferrous iron with L-malic acid-a key intermediate of the Krebs cycle-this compound supports efficient mineral absorption while minimizing the gastrointestinal irritation and metallic aftertaste typical of inorganic iron salts.
Manufactured under strict ISO and cGMP protocols, our production utilizes inert gas protection during synthesis to prevent the oxidation of Fe²⁺ to Fe³⁺, ensuring high batch consistency, controlled particle size distribution, and low heavy metal profiles for industrial manufacturing.
Key Specifications
|
Test Parameter |
Specification Standard |
Test Method |
|
Appearance |
Pale yellowish-white to light grey powder |
Visual Inspection |
|
Assay (Fe content) |
18.0% – 22.0% (anhydrous basis) |
Titrimetry (USP) |
|
Ferrous Iron (Fe²⁺) |
≥ 95.0% of total iron |
Redox Titration |
|
Loss on Drying |
≤ 3.0% |
105°C, 2 hours |
|
pH (5% aqueous solution) |
3.5 - 5.5 |
Potentiometric Determination |
|
Lead (Pb) |
≤ 2.0 mg/kg |
ICP-MS |
|
Arsenic (As) |
≤ 1.0 mg/kg |
ICP-MS |
|
Cadmium (Cd) |
≤ 1.0 mg/kg |
ICP-MS |
|
Mercury (Hg) |
≤ 0.1 mg/kg |
ICP-MS |
|
Bulk Density |
0.40 - 0.65 g/ml |
ASTM D1895 |
Applications
Dietary Supplements: Encapsulation and tableting for daily wellness formulas and iron-deficiency correction products.
Maternal Care: Formulated into prenatal vitamins due to high gastrointestinal tolerance and absorption profiles.
Functional Foods & Beverages: Mineral fortification agent for nutritional powders, meal replacement shakes, and functional drinks.
Pharmaceuticals: Active ingredient for oral liquid suspensions, syrups, and pediatric drops.
Product Grades & Options
Food Grade: Conforms to FCC specifications, designed for general nutritional supplements and fortified foods.
Pharmaceutical Grade: Conforms to USP/EP monographs with rigorous microbiological controls and complete impurity profiling.
Custom Particle Sizing: Available in standard mesh distributions (e.g., 80 mesh) or micronized options customized for direct compression and high-shear wet granulation.
Quality Control & Manufacturing Standards
Our manufacturing operations comply with ISO 9001, FSSC 22000, and cGMP standards.
Process Control: Reaction synthesis is performed in closed stainless-steel reactors under controlled temperature and inert atmosphere to safeguard iron valency.
Analytical Verification: In-house laboratory testing uses Inductively Coupled Plasma Mass Spectrometry (ICP-MS) for heavy metal quantification and Atomic Absorption Spectroscopy (AAS) for assay validation.
Traceability: Complete batch documentation, electronic chromatography records, and 3-year retain samples are archived for every production run.
Regulatory Documentation: Batch-specific Certificate of Analysis (COA), MSDS, TSE/BSE-free statement, allergen declaration, and non-GMO certification supplied upon request.
Packaging & Storage
Packaging: 25 kg net fiber drums featuring dual-layer food-grade low-density polyethylene (LDPE) inner liners.
Storage Requirements: Store in a dry, cool, well-ventilated area. Keep containers tightly closed to protect against moisture uptake and aerial oxidation.
Shelf Life: 24 months from the date of manufacture in unopened original packaging.
FAQ
Q: What is the primary advantage of Ferrous Malate over traditional iron salts?
A: Ferrous Malate pairs bivalent iron with malic acid, an endogenous cellular metabolite. This organic structure improves gastrointestinal tolerance, decreases the incidence of common side effects like constipation, and eliminates heavy metallic aftertastes compared to ferrous sulfate.
Q: Does this product comply with USP or FCC monographs?
A: Yes. Our manufacturing and testing protocols adhere strictly to USP and FCC standards. Compliance is verified and documented on the Certificate of Analysis provided with every shipment.
Q: What is the minimum order quantity (MOQ) for bulk shipments?
A: The standard MOQ for direct factory shipments is 500 kg. R&D trial quantities (100g – 1 kg) are available for laboratory evaluation and preliminary formulation testing.
Q: Can you adjust the particle size for direct compression tableting?
A: Yes. We offer customized milling and mechanical sieving parameters to meet specific particle size distribution requirements for direct-compression or high-speed encapsulation equipment.
Q: What documentation is included with each delivery?
A: Every delivery includes a batch-specific Certificate of Analysis (COA), packing list, and bill of lading. Additional technical dossiers, including heavy metal screening reports and stability data, are available through our technical support team.
Q: What are the standard payment terms for established B2B accounts?
A: For initial evaluation orders, payment is handled via bank wire transfer (T/T). For qualified annual supply contracts, standard commercial terms include T/T (30% deposit, 70% against shipping documents) or confirmed Letter of Credit (L/C) at sight.
Request a Quote & Technical Documentation
Submit your technical specifications, annual volume projections, and destination port to receive a formal commercial quotation, batch COA, and analytical sample within 24 business hours.
- [Request Sample & COA]
- [Contact Technical Engineering Team]
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