FERROUS GLUCONATE – DEMİR GLUKONAT

CAS Number: 299-29-6 (Anhydrous), 22830-45-1 (Dihydrate)
EC Number (EINECS): 206-076-3
Molecular Formula: C₁₂H₂₂FeO₁₄ (Anhydrous), C₁₂H₂₂FeO₁₄·2H₂O (Dihydrate)
Molecular Weight: 446.14 g/mol (Anhydrous), 482.17 g/mol (Dihydrate)
E Number: E579

SECTION 1: CHEMICAL IDENTITY AND DEFINITION

Parameter	Information
Chemical Name (IUPAC)	Iron(2+) Gluconate / Iron(II) Gluconate
Other Names	Ferrous Gluconate, Iron Gluconate, Ferrum Gluconicum, Bis(D-gluconato)iron, Iron Bis(D-gluconato)
Chemical Formula (Anhydrous)	C₁₂H₂₂FeO₁₄
Chemical Formula (Dihydrate)	C₁₂H₂₂FeO₁₄·2H₂O
Molecular Weight (Anhydrous)	446.14 g/mol
Molecular Weight (Dihydrate)	482.17 g/mol
CAS Number (Anhydrous)	299-29-6
CAS Number (Dihydrate)	22830-45-1
EC Number (EINECS)	206-076-3
E Number	E579 (Food additive)
Chemical Class	Organic iron salt (gluconate)
Appearance	Light yellowish-gray to greenish-yellow, fine powder or granules
Odor	Slight characteristic
Physical State (20°C)	Solid (powder or granules)
UNII (FDA)	U5X7F30P1W

SECTION 2: PHYSICAL PROPERTIES

Property	Value
Appearance	Light yellowish-gray to greenish-yellow, fine powder or granules
Odor	Slight characteristic
Molecular Weight (Anhydrous)	446.14 g/mol
Molecular Weight (Dihydrate)	482.17 g/mol
Melting Point	Decomposes above 150°C
Density	~1.5 g/cm³
Solubility in Water (20°C)	Soluble (~119 g/L)
Solubility in Hot Water	Highly soluble (increases with temperature)
Solubility in Ethanol	Insoluble
Solubility in Ether	Insoluble
pH (1:10 aqueous solution)	4.0 – 5.5 (slightly acidic)
Color Change (pH 4.5)	Yellow-green to brown (oxidation to Fe³⁺)
Color Change (pH 7)	Green (Fe²⁺ hydroxide complexes)

SECTION 3: CHEMICAL PROPERTIES

Property	Information
Chemical Formula (Anhydrous)	C₁₂H₂₂FeO₁₄
Chemical Formula (Dihydrate)	C₁₂H₂₂FeO₁₄·2H₂O
Molecular Weight (Anhydrous)	446.14 g/mol
Molecular Weight (Dihydrate)	482.17 g/mol
Chemical Class	Organic iron salt (gluconate)
Structure	Iron(II) salt of gluconic acid
Elemental Iron Content	~12% (by weight)
SMILES	C(C(C(C(C(C(=O)[O-])O)O)O)O)O.C(C(C(C(C(C(=O)[O-])O)O)O)O)O.[Fe+2]
InChI Key	BNZJJDGLXXGSEK-UHFFFAOYSA-L
Stability	Sensitive to light and oxygen; oxidizes to Fe³⁺ over time
Hygroscopicity	Low
Incompatible Materials	Strong oxidizing agents, strong bases, strong acids

Chemical Structure:

    CH₂OH
      |
    (CHOH)₄
      |
    COO⁻
       \
        Fe²⁺ (Iron(II) Ion)
       /
    COO⁻
      |
    (CHOH)₄
      |
    CH₂OH

SECTION 4: COLOR AND PH BEHAVIOR

pH Range	Color	Explanation
Low pH (Acidic)	Light yellow to greenish	Characteristic color of Fe²⁺ ions
pH ~4.5	Brown	Oxidation of Fe²⁺ to Fe³⁺ begins; iron(III) hydroxide forms
pH 7 (Neutral)	Green	Iron(II) hydroxide complexes form; rapidly oxidizes to brown
Alkaline	Brown/Precipitate	Iron hydroxide precipitates; product becomes unstable

SECTION 5: SOLUBILITY ENHANCERS AND STABILIZERS

Additive	Effect
Citric Acid	Chelates iron ions; increases solubility; slows oxidation
Trisodium Citrate	Chelates iron ions; improves stability; prevents precipitation
Ascorbic Acid (Vitamin C)	Antioxidant; prevents Fe²⁺ oxidation to Fe³⁺; enhances absorption
Sorbitol	Solubility enhancer; improves palatability
Sugar Syrup	Improves taste; masks metallic flavor

SECTION 6: MANUFACTURING PROCESSES

6.1. Barium Gluconate and Iron Sulfate Method

Step	Process	Description
1	Reaction	Ba(C₆H₁₁O₇)₂ + FeSO₄ → Fe(C₆H₁₁O₇)₂ + BaSO₄↓
2	Precipitation	Barium sulfate (BaSO₄) precipitates as a white solid
3	Filtration	Filter to remove BaSO₄ precipitate
4	Crystallization	Evaporate filtrate to crystallize ferrous gluconate
5	Drying	Vacuum drying

6.2. Iron Carbonate and Gluconic Acid Method

Step	Process	Description
1	Preparation	Freshly prepared iron(II) carbonate slurry
2	Reaction	FeCO₃ + 2 C₆H₁₂O₇ → Fe(C₆H₁₁O₇)₂ + CO₂↑ + H₂O
3	Reaction Condition	Gradual addition with heating; CO₂ gas evolution observed
4	Filtration	Filter to remove insoluble impurities
5	Concentration	Evaporate under vacuum
6	Crystallization	Allow crystallization
7	Drying	Vacuum drying

SECTION 7: PHARMACEUTICAL APPLICATIONS

Application	Description
Iron Deficiency Anemia	Primary therapeutic use; replenishes hemoglobin
Hemoglobin Synthesis	Iron is central to hemoglobin; enables oxygen transport
Ferritin Formation	Supports ferritin (iron storage protein) production in liver, spleen, bone marrow
Multivitamin Formulations	Component of daily multivitamin supplements
Pediatric Supplements	Preferred for children due to better tolerance
Prenatal Supplements	Used during pregnancy to meet increased iron demand
Liquid Oral Solutions	Often formulated with citric acid for stability

SECTION 8: COMPARISON WITH OTHER IRON COMPOUNDS

Property	Ferrous Gluconate	Ferrous Sulfate	Ferrous Fumarate
Elemental Iron Content	~12%	~20%	~33%
GI Side Effects	Lower	Higher	Moderate
Solubility in Water	Good (119 g/L)	Very Good	Poor
Absorption	Good	Good	Good
Taste	Mild metallic	Strong metallic	Mild metallic
Color	Yellowish-green	Greenish-blue	Reddish-brown
Oral Tolerance	Better	Poorer	Moderate
Common Use	Oral supplements, pediatric	Oral supplements, water treatment	Oral supplements

SECTION 9: FOOD INDUSTRY APPLICATIONS (E579)

Application	Description
Food Fortification	Iron source for enriched foods; added to processed cereals and baby foods
Breakfast Cereals	Iron loss during processing is compensated by fortification
Baby Formulas	High iron demand during rapid growth; ensures adequate intake
Soy and Corn Products	Chelated form less affected by phytate inhibitors
Olive Blackening (E579)	Used to stabilize black color in olives; iron reacts with polyphenols
Bakery Products	Dough strengthening; iron fortification
Milk Powder	Iron fortification
Dietary Supplements	Direct iron source for supplements

SECTION 10: QUALITY SPECIFICATIONS (Ph. Eur.)

Parameter	Specification
Appearance	Light yellowish-gray to greenish-yellow powder/granules
Identification	Positive (Iron and Gluconate tests)
Assay (on dried basis)	97.0 – 102.0%
Loss on Drying	5.0 – 8.0% (dihydrate)
Chlorides (Cl)	≤ 0.07%
Sulfates (SO₄)	≤ 0.1%
Oxalic Acid	≤ 0.1%
Reducing Sugars	≤ 1.0%
Ferric Iron (Fe³⁺)	≤ 0.5%
Lead (Pb)	≤ 2 ppm
Arsenic (As)	≤ 1 ppm
Mercury (Hg)	≤ 0.1 ppm
Barium (Ba)	≤ 10 ppm (due to method 1 production risk)
Heavy Metals	≤ 10 ppm

SECTION 11: STABILITY AND STORAGE

Parameter	Information
Stability	Sensitive to light, oxygen, and moisture
Oxidation	Fe²⁺ oxidizes to Fe³⁺ over time; color darkens (brownish)
Storage Conditions	Cool (15-25°C), dry, well-ventilated area
Container Requirements	Tightly closed, light-resistant (amber glass or opaque containers)
Protect From	Light, air, strong oxidizing agents, strong bases
Shelf Life	36-60 months (unopened original packaging)
Stability Note	Color change (darkening) indicates oxidation to ferric form

SECTION 12: PACKAGING OPTIONS

Packaging Type	Quantity	Material
PE-lined fiber drum	25 kg	HDPE drum + PE bag
Aluminum foil bag	1-5 kg	Laminated aluminum
Glass bottle	100-500 g	Amber glass
Plastic pail	20-25 kg	HDPE
Big-Bag	500-1000 kg	Polypropylene

SECTION 13: SAFETY AND HEALTH INFORMATION

GHS Classification (Bulk Powder)

Hazard Class	Category
Acute Toxicity (Oral)	Category 4 (H302)
Skin Irritation	Category 2 (H315)
Eye Irritation	Category 2A (H319)
Specific Target Organ Toxicity (STOT - SE)	Category 3 (H335)

Hazard Statements (H-Codes)

Code	Statement
H302	Harmful if swallowed
H315	Causes skin irritation
H319	Causes serious eye irritation
H335	May cause respiratory irritation

Precautionary Statements (P-Codes)

Code	Statement
P261	Avoid breathing dust
P280	Wear protective gloves/eye protection
P301+P312	IF SWALLOWED: Call a POISON CENTER/doctor if you feel unwell
P302+P352	IF ON SKIN: Wash with plenty of soap and water
P305+P351+P338	IF IN EYES: Rinse cautiously with water for several minutes; remove contact lenses if present and easy to do; continue rinsing

SECTION 14: FIRST AID MEASURES

Exposure Route	Action
Inhalation	Move to fresh air. If respiratory irritation persists, seek medical attention.
Skin Contact	Wash with plenty of soap and water. Remove contaminated clothing.
Eye Contact	Rinse immediately with plenty of water for at least 15 minutes. Seek medical attention.
Ingestion	Rinse mouth. Do not induce vomiting. Seek medical attention.
Overdose	Iron poisoning (vomiting, diarrhea, liver failure); emergency medical intervention required

SECTION 15: TOXICOLOGY

Parameter	Value
Oral LD50 (Rat)	2,000-3,000 mg/kg
Carcinogenicity	Not classified as carcinogenic
Mutagenicity	Negative in standard tests
Reproductive Toxicity	No evidence of adverse effects
ADI (JECFA)	0.1-0.5 mg/kg bw/day (as iron)

SECTION 16: TOXICITY BY EXPOSURE ROUTE

Route	Acute Toxicity	Chronic Toxicity
Oral	Harmful if swallowed (H302)	Iron overload (hemosiderosis, liver damage) with prolonged high-dose exposure
Inhalation	Respiratory irritation (H335)	Lung irritation with repeated exposure
Skin	Skin irritation (H315)	Sensitization possible with repeated contact
Eye	Serious eye irritation (H319)	N/A

SECTION 17: REGULATORY STATUS

Region / Authority	Status
European Union	Approved as E579 (food additive)
USA (FDA)	GRAS as iron supplement
Turkey	Approved (Türk Gıda Kodeksi)
JECFA (FAO/WHO)	Approved; ADI: 0-0.5 mg/kg bw/day (as iron)
Codex Alimentarius	Approved (E579)
Ph. Eur.	Monograph included
USP	Monograph included

SECTION 18: TRANSPORT INFORMATION

Parameter	Information
UN Number	Not regulated (not dangerous goods)
Hazard Class	Not applicable
Packing Group	Not applicable
ADR/RID	Not regulated
IMDG Code	Not regulated
IATA (Air)	Not regulated
Marine Pollutant	No

SECTION 19: FIRE-FIGHTING MEASURES

Parameter	Information
Fire Hazard	Non-combustible (organic salt)
Suitable Extinguishing Media	Water spray (mist), CO₂, dry chemical powder
Specific Hazards	When heated, emits iron oxide fumes, CO, CO₂
Decomposition Products	Iron oxides, CO, CO₂
Protective Equipment	Self-contained breathing apparatus (SCBA), full protective clothing

SECTION 20: ACCIDENTAL SPILLAGE AND CLEANUP

Parameter	Information
Personal Protection	Nitrile gloves, protective goggles, dust mask (N95)
Cleaning Methods	Collect mechanically (sweep or spatula)
Environmental Precautions	Prevent entry into drains, soil, and surface waters
Waste Disposal	According to local regulations; incineration or landfilling at licensed facilities

SECTION 21: OTHER NAMES AND SYNONYMS

Type	Name
Turkish Names	Demir Glukonat, Ferro Glukonat, Demir(II) Glukonat
English Names	Ferrous Gluconate, Iron Gluconate, Iron(2+) Gluconate, Iron(II) Gluconate
Chemical Names	Bis(D-gluconato)iron, D-Gluconic acid iron(2+) salt
Trade Names	Fergon®, Ferralet®, Simron®, Ferro Glukon®
E Number	E579
CAS (Anhydrous)	299-29-6
CAS (Dihydrate)	22830-45-1
UNII	U5X7F30P1W
Latin	Ferrum Gluconicum
French	Gluconate de Fer
German	Glukonsaures Eisen(II)

SECTION 22: SUMMARY AND CRITICAL NOTES

Product Summary

Parameter	Value
Product	Ferrous Gluconate / Iron Gluconate
CAS (Anhydrous)	299-29-6
CAS (Dihydrate)	22830-45-1
E Number	E579
Appearance	Light yellowish-gray to greenish-yellow powder
Molecular Weight	446.14 g/mol (Anhydrous)
Elemental Iron	~12%
Primary Use	Iron supplement, food fortification

Key Properties

Property	Description
Elemental Iron Content	~12% (lower than sulfate or fumarate)
GI Tolerance	Better than ferrous sulfate
Color	pH-dependent; stable in slightly acidic conditions
Stability	Requires protection from light and oxygen

Critical Notes

Elemental Iron Content: Ferrous gluconate contains approximately 12% elemental iron, lower than ferrous sulfate (20%) or ferrous fumarate (33%).
GI Tolerance: Better tolerated than ferrous sulfate; preferred for patients with sensitive gastrointestinal systems.
Color Sensitivity: Color changes with pH; brown color indicates Fe²⁺ oxidation to Fe³⁺.
Light Sensitivity: Must be stored in light-resistant containers to prevent degradation.
Food Additive (E579): Used in food fortification and olive blackening.
Pharmaceutical Use: Primary treatment for iron deficiency anemia; also used in pediatric and prenatal supplements.
Oxidation: Fe²⁺ oxidizes to Fe³⁺ over time, reducing bioavailability; must be protected from air and moisture.
Better Tolerance: Causes fewer gastrointestinal side effects (nausea, constipation, stomach pain) compared to ferrous sulfate.
Solubility Enhancers: Citric acid, trisodium citrate, and ascorbic acid improve solubility, stability, and absorption.
Regulatory Status: Approved in EU (E579), FDA (GRAS), JECFA, and Ph. Eur./USP monographs.

IMPORTANT DECLARATION: This Technical Data Sheet (TDS) is for informational purposes only and has been prepared based on available technical data. The user is responsible for determining the product's suitability for their specific application and for complying with all local, national, and international regulations. For complete safety, storage, use, transport, waste, and regulatory compliance information, refer to the official Safety Data Sheet (SDS/MSDS) provided by the manufacturer/supplier. This document does not replace medical advice. Iron supplements should be used under medical guidance. Overdose is a medical emergency requiring immediate intervention.

Ferrous Gluconate, Iron Gluconate, E579, 299-29-6, 22830-45-1

FERROUS GLUCONATE – DEMİR GLUKONAT

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