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Send EmailZinc Gluconate, Zinc D-Gluconate, Zinc Gluconate Anhydrous, E578, 4468-02-4
ZINC GLUCONATE
PRODUCT IDENTIFIER INFORMATION
| Parameter | Information |
|---|---|
| Product Name | Zinc Gluconate |
| Chemical Name (IUPAC) | Zinc bis[(2R,3S,4R,5R)-2,3,4,5,6-pentahydroxyhexanoate] |
| CAS Number | 4468-02-4 |
| EC Number (EINECS) | 224-736-9 |
| Food Additive Code | E578 |
| Molecular Formula | C12H22O14Zn |
| Molecular Weight | 455.68 g/mol |
SECTION 1: CHEMICAL IDENTITY AND DESCRIPTION
| Parameter | Information |
|---|---|
| Chemical Name (IUPAC) | Zinc bis[(2R,3S,4R,5R)-2,3,4,5,6-pentahydroxyhexanoate] |
| Synonyms | Zinc Gluconate, Rubozine, Zine Gluconate, Gluconic Acid Zinc Salt, D-Gluconic Acid Zinc Salt, Zinc D-Gluconate, Zinc Gluconate Anhydrous, bis(D-gluconato-κO1,κO2)zinc |
| CAS Number | 4468-02-4 |
| EC Number (EINECS) | 224-736-9 |
| Food Additive Code | E578 |
| Molecular Formula | C12H22O14Zn |
| Molecular Weight | 455.68 g/mol |
| Chemical Class | Organic acid salt (zinc salt of gluconic acid) |
| Zinc Content | ~14.3% |
| Physical State (20°C) | Solid (white crystalline powder or granular powder) |
| Odor | Odorless |
| Taste | Tasteless or slightly characteristic |
SECTION 2: PHYSICAL AND CHEMICAL PROPERTIES
| Property | Value | Test Method |
|---|---|---|
| Appearance | White crystalline powder or granular powder | Visual |
| Odor | Odorless | Olfactometric |
| Taste | Tasteless or slightly characteristic | Sensory |
| Molecular Weight | 455.68 g/mol | Calculated |
| Zinc Content | ~14.3% | AAS / Complexometric Titration |
| Melting Point | 172 – 175°C | DSC |
| Boiling Point | 319°C (decomposes) | TGA |
| Density (20°C) | 1.44 g/cm3 | ASTM D4052 |
| Specific Optical Rotation ([α]D20) | +8.0° to +11.0° (c=1, water) | Polarimetry |
| Flash Point | 375.2°C | ASTM D93 |
| Solubility in Water (25°C) | Soluble (~100 g/L) | Gravimetric |
| Solubility in Ethanol | Insoluble | General Method |
| Solubility in Chloroform | Insoluble | General Method |
| Solubility in Ether | Insoluble | General Method |
| pH (1% solution, 25°C) | 5.5 – 7.5 | pH Meter |
| Vapor Pressure (20°C) | 0 Pa | Calculated |
| Light Sensitivity | Sensitive to light | Visual |
| Stability | Stable under normal conditions |
SECTION 3: CHEMICAL PROPERTIES AND REACTIVITY
| Parameter | Information |
|---|---|
| Chemical Character | Organic zinc salt; high bioavailability |
| Stability | Stable under normal conditions; light-sensitive |
| Decomposition Products (Heating) | Above 319°C: CO, CO2, ZnO, gluconic acid derivatives |
| Incompatible Materials | Strong oxidizing agents, strong acids |
| Reaction with Acids | Releases gluconic acid with strong acids |
| Hazardous Polymerization | Does not occur |
SECTION 4: PRODUCTION METHODS
| Method | Description |
|---|---|
| Fermentation Method | Glucose fermented with Aspergillus niger to obtain gluconic acid; after purification, neutralized with zinc oxide or zinc hydroxide |
| Air Catalytic Oxidation | Glucose oxidized by air in presence of catalyst; converted to sodium gluconate with NaOH; converted to gluconic acid via ion exchange resin; reacted with ZnO |
| Calcium Gluconate Indirect Synthesis | Calcium gluconate acidified with sulfuric acid; CaSO4 precipitate filtered; purified via ion exchange resin; reacted with ZnO |
SECTION 5: ZINC SALTS COMPARISON
| Property | Zinc Gluconate | Zinc Sulfate | Zinc Lactate | Zinc Citrate | Zinc Oxide |
|---|---|---|---|---|---|
| CAS Number | 4468-02-4 | 7733-02-0 | 16039-53-5 | 546-46-3 | 1314-13-2 |
| Molecular Formula | C12H22O14Zn | ZnSO4·7H2O | C6H10O6Zn | C12H10O14Zn3 | ZnO |
| Zinc Content | ~14.3% | ~22% | ~22% | ~31% | ~80% |
| Bioavailability | High | Moderate | High | Moderate-High | Low-Moderate |
| Taste | Tasteless/slightly sweet | Metallic/bitter | Neutral | Neutral | Tasteless |
| Gastric Irritation | Very Low | High | Low | Low | Moderate |
| Solubility in Water | ~100 g/L | Very high | Slight | Moderate | Insoluble |
| Primary Use | Supplement, lozenge, food | Supplement, agriculture | Supplement, oral care | Supplement | Cream, ointment |
SECTION 6: FUNCTIONAL PROPERTIES AND MECHANISM OF ACTION
| Property | Description |
|---|---|
| Zinc Supplementation | Highly bioavailable organic zinc source; less gastric irritation compared to inorganic zinc salts |
| Immune Support | Essential for thymus gland development; supports T-lymphocyte differentiation and cellular immunity |
| Growth and Development | Essential for protein synthesis, DNA synthesis, and cell division; critical in child development |
| Antioxidant Activity | Activates zinc-dependent antioxidant enzymes (SOD); reduces free radical damage |
| Wound Healing | Required for collagen synthesis and tissue repair |
| Taste and Appetite Regulation | Essential for taste bud function; regulates appetite |
| Insulin Metabolism | Involved in insulin synthesis, storage, and release; increases insulin sensitivity |
| Vitamin A Metabolism | Required for mobilization of vitamin A from the liver; supports visual function |
SECTION 7: PRIMARY APPLICATION AREAS
| Sector | Application | Typical Usage / Dosage |
|---|---|---|
| Dietary Supplement | Tablets, capsules, lozenges, effervescent tablets | 15-50 mg Zn/day |
| Food Fortification | Salt (800-1000 mg/kg); dairy products (230-470 mg/kg); infant food (195-545 mg/kg) | Per regulations |
| Food Fortification | Cereal products (160-320 mg/kg); beverages (40-80 mg/kg) | Per regulations |
| Pharmaceutical | Zinc deficiency treatment; acne, eczema, oral ulcers | 15-50 mg Zn/day |
| Pharmaceutical | Growth retardation, malnutrition, anorexia | 15-50 mg Zn/day |
| Cosmetic | Acne treatment, antifungal, antiviral skin products | 0.1-1.0% |
| Oral Care | Lozenges, throat spray (antiviral, immune support) | 5-15 mg Zn/lozenge |
SECTION 8: QUALITY SPECIFICATIONS (USP/EP/FCC GRADE)
| Parameter | Specification | Test Method |
|---|---|---|
| Appearance | White crystalline or granular powder | Visual |
| Odor | Odorless | Olfactometric |
| Purity (Dry Basis) | 97.0 – 102.0% | Complexometric Titration (EDTA) |
| Zinc Content (Zn) | 12.5 – 14.5% | AAS / Complexometric Titration |
| Loss on Drying (105°C, 2 hours) | ≤ 11.6% (trihydrate); ≤ 0.5% (anhydrous) | Gravimetric |
| pH (1% solution, 25°C) | 5.5 – 7.5 | pH Meter |
| Specific Optical Rotation ([α]D20) | +8.0° to +11.0° (c=1, water) | Polarimetry |
| Chloride (Cl-) | ≤ 0.05% | Argentometric |
| Sulfate (SO4 2-) | ≤ 0.05% | Turbidimetric |
| Heavy Metals (as Pb) | ≤ 20 ppm | ICP-MS / USP <231> |
| Lead (Pb) | ≤ 3 ppm | ICP-MS |
| Arsenic (As) | ≤ 3 ppm | ICP-MS |
| Mercury (Hg) | ≤ 1 ppm | ICP-MS |
| Cadmium (Cd) | ≤ 1 ppm | ICP-MS |
| Reducing Substances | ≤ 1.0% | Titrimetric |
| Total Microbial Count | ≤ 1,000 CFU/g | USP <61> |
| Yeast and Mold | ≤ 100 CFU/g | USP <61> |
| E. coli | Negative in 10g | USP <62> |
| Salmonella spp. | Negative in 25g | USP <62> |
SECTION 9: TOXICOLOGICAL PROFILE
| Parameter | Value |
|---|---|
| Acute Oral Toxicity (LD50, Mouse, Female) | ~1,930 mg/kg |
| Acute Oral Toxicity (LD50, Mouse, Male) | ~2,990 mg/kg |
| Acute Dermal Toxicity (LD50, Rabbit) | > 2,000 mg/kg |
| Skin Irritation | Mild irritant |
| Eye Irritation | Mild-moderate irritant |
| Respiratory Irritation | Inhalation of dust may cause mechanical irritation |
| Carcinogenicity | Not classified |
| Mutagenicity | Negative in in vitro tests |
| Reproductive Toxicity | Moderate risk (cosmetic database); systemic effects at low doses in animal studies |
| Chronic Toxicity | Gastrointestinal discomfort at high doses; copper deficiency |
| Tolerable Upper Intake Level (UL) | 40 mg Zn/day for adults |
| GRAS Status | Recognized as GRAS by FDA (21 CFR 182.8988) |
SECTION 10: GHS CLASSIFICATION AND LABELING
GHS Classification (compliant with 1272/2008/EC):
| Hazard Class | Category | H-Statement |
|---|---|---|
| Not classified | - | Not classified as hazardous according to current regulations |
Signal Word: No signal word
Hazard Pictograms: No pictograms required
Precautionary Statements:
| Code | Statement |
|---|---|
| P261 | Avoid breathing dust |
| P280 | Wear protective gloves/eye protection |
SECTION 11: FIRST AID MEASURES
| Exposure Route | Action to Take |
|---|---|
| Inhalation | Move to fresh air. Seek medical attention if respiratory irritation persists. |
| Skin Contact | Wash with plenty of water and soap. Seek medical attention if irritation persists. |
| Eye Contact | Rinse immediately with plenty of water for at least 15 minutes. Remove contact lenses if present. Seek medical attention. |
| Ingestion | Rinse mouth with water. Drink plenty of water. Seek medical attention if you feel unwell. |
SECTION 12: FIREFIGHTING MEASURES
| Parameter | Information |
|---|---|
| Fire Hazard | Non-flammable |
| Flash Point | 375.2°C |
| Hazards During Fire | CO, CO2, ZnO particulates |
| Suitable Extinguishing Media | Water mist, CO2, dry chemical powder, foam |
| Special Protective Equipment | Self-contained breathing apparatus (SCBA), full protective clothing |
SECTION 13: STORAGE AND SHELF LIFE
| Parameter | Information |
|---|---|
| Storage Conditions | Room temperature (15-25°C), dark, dry, well-ventilated area |
| Container Requirements | Tightly closed, light-resistant containers |
| Keep Away From | Light (light-sensitive), moisture, strong oxidizing agents, strong acids |
| Shelf Life | 36 months (unopened original packaging under appropriate storage conditions) |
| Stability Note | Light-sensitive; store in dark environment |
SECTION 14: PACKAGING OPTIONS
| Packaging Type | Quantity | Material |
|---|---|---|
| Aluminum foil pouch (light-protective) | 1 kg | Laminated aluminum |
| Aluminum foil pouch (light-protective) | 5 kg | Laminated aluminum |
| Kraft bag with PE inner liner | 25 kg | Kraft paper + PE |
| Fiber drum | 25-50 kg | Fiberboard + PE |
SECTION 15: TRANSPORTATION INFORMATION
| Parameter | Information |
|---|---|
| UN Number | Not regulated |
| Hazard Class | Not applicable |
| ADR/RID | Not regulated |
| IMDG Code | Not regulated |
| IATA (Air) | Not regulated |
| Marine Pollutant | No |
SECTION 16: REGULATORY STATUS
| Region / Authority | Status |
|---|---|
| European Union | Food additive E578; approved as zinc source in food supplements |
| USA (FDA) | GRAS (21 CFR 182.8988); unlimited under GMP |
| USP-NF | Official monograph available |
| JECFA (FAO/WHO) | Evaluated as food additive |
| Turkey | Approved for dietary supplement and food fortification |
| Halal / Kosher / Vegan | Available |
SECTION 17: OTHER NAMES AND SYNONYMS
| Type | Name |
|---|---|
| Common Names | Zinc Gluconate, Rubozine, Zine Gluconate, Gluconic Acid Zinc Salt |
| Chemical Names | Zinc D-Gluconate, D-Gluconic Acid Zinc Salt, bis(D-gluconato-κO1,κO2)zinc |
| Food Additive Code | E578 |
| CAS Number | 4468-02-4 |
| EC Number | 224-736-9 |
SECTION 18: SUMMARY TABLE
| Parameter | Value |
|---|---|
| Product | Zinc Gluconate |
| CAS Number | 4468-02-4 |
| Food Additive Code | E578 |
| Molecular Formula | C12H22O14Zn |
| Molecular Weight | 455.68 g/mol |
| Appearance | White crystalline powder |
| Zinc Content | ~14.3% |
| Melting Point | 172 – 175°C |
| Solubility in Water | ~100 g/L |
| Primary Function | Zinc supplementation, immune support, growth and development |
| Shelf Life | 36 months |
| GHS Signal Word | Not classified |
SECTION 19: CRITICAL WARNINGS AND BEST PRACTICES
CRITICAL WARNINGS:
-
Light Sensitivity: Light-sensitive; store in light-resistant containers in a dark environment.
-
Zinc Toxicity: Excessive intake (above 40 mg/day) may cause copper deficiency and impaired immune function.
-
Empty Stomach: Should not be taken on an empty stomach; may cause gastric discomfort.
-
Drug Interactions: May reduce absorption of tetracycline antibiotics and quinolones; should be taken at least 2 hours apart.
-
Nasal Use Warning: FDA has warned that zinc-containing nasal sprays may cause loss of smell (not applicable to oral use).
BEST PRACTICE RECOMMENDATIONS:
-
Dosage: Daily 15-50 mg elemental zinc for adults; recommended to be taken after meals.
-
Bioavailability: Approximately 1.6 times higher bioavailability compared to inorganic zinc salts (sulfate).
-
Storage: Store in light-resistant containers in a dark and dry environment.
-
Formulation: Suitable for lozenges and effervescent tablets; neutral taste does not affect formulation.
-
Food Fortification: Use dosage compliant with local regulatory limits.
LEGAL DISCLAIMER:
The information provided in this document is presented in good faith based on our current knowledge and experience; however, since all usage conditions are beyond our control, it does not constitute a binding specification or warranty. This Technical Data Sheet is for informational purposes only and does not constitute medical advice. Users are obligated to test the suitability for their own applications. For complete safety, storage, handling, transportation, disposal, and regulatory compliance information, refer to the official Safety Data Sheet (SDS/MSDS) provided by the manufacturer/supplier. This product is not intended to diagnose, treat, cure, or prevent any disease.
