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Mannitol, D-Mannitol, L-Mannitol, Osmitrol, Manna Sugar, Cordycepic Acid, Sea Crystal, E421, 69-65-8

Mannitol, D-Mannitol, L-Mannitol, Osmitrol, Manna Sugar, Cordycepic Acid, Sea Crystal, E421, 69-65-8

MANNITOL – MANNİTOL

CAS Number: 69-65-8
EC Number (EINECS): 200-711-8
Molecular Formula: C₆H₁₄O₆
Molecular Weight: 182.17 g/mol
E Number: E421

SECTION 1: CHEMICAL IDENTITY AND DEFINITION

Parameter Information
Chemical Name (IUPAC) (2R,3R,4R,5R)-Hexane-1,2,3,4,5,6-hexol
Other Names Mannitol, D-Mannitol, Osmitrol, Manna Sugar, Manna Sugar, Kordisepik Acid, Sea Crystal, Osmofundin, Maniton-S, L-Mannitol
Chemical Formula C₆H₁₄O₆
Molecular Weight 182.17 g/mol
CAS Number 69-65-8
EC Number (EINECS) 200-711-8
E Number E421 (Sweetener, humectant, anti-caking agent)
Chemical Class Sugar alcohol (polyol)
Appearance White, crystalline powder or granules
Odor Slightly characteristic
Taste Sweet (~50-60% of sucrose)
Physical State (20°C) Solid (crystalline powder or granules)

SECTION 2: PHYSICAL PROPERTIES

Property Value
Appearance White, crystalline powder or granules
Odor Slightly characteristic
Taste Sweet (~50-60% of sucrose)
Molecular Weight 182.17 g/mol
Melting Point 166 – 168 °C
Boiling Point 290 – 295 °C
Density (20°C) 1.52 g/cm³
Solubility in Water (25°C) 216 g/L
Solubility in Water (20°C) 180 g/L
Solubility in Glycerin 1 g / 18 mL
Solubility in Ethanol Slightly soluble
Solubility in Ether Practically insoluble
pH (5% solution) 5.0 – 7.0 (neutral)
Hygroscopicity Low (non-hygroscopic)
Sweetness (Sucrose = 100) ~50-60
Caloric Value ~2.5 kcal/g
Specific Rotation [α]D²⁰ +23° to +25°
Refractive Index (nD²⁰) ~1.46

SECTION 3: CHEMICAL PROPERTIES

Property Information
Chemical Formula C₆H₁₄O₆
Molecular Weight 182.17 g/mol
Chemical Class Sugar alcohol (polyol)
Functional Groups Six hydroxyl (-OH) groups
Structure Hexahydric alcohol derivative
SMILES C(C@@HO)O
InChI Key FBPFZTCFMRRESA-KVTDHHQDSA-N
Stability Stable under normal storage conditions
Hygroscopicity Low (non-hygroscopic)
Cariogenicity Non-cariogenic (does not promote tooth decay)
Incompatible Materials Strong oxidizing agents, strong acids

Chemical Structure:

    CH₂OH
      |
    (CHOH)₄
      |
    CH₂OH

(D-Mannitol)

SECTION 4: NATURAL SOURCES

Source Description
Fruits and Vegetables Naturally occurring
Mushrooms Functions as sugar and carbohydrate reserve
Seaweed Industrial source
Manna (Fraxinus ornus) Known as "Manna sugar"

SECTION 5: MANUFACTURING PROCESS

Stage Process Description
1 Hydrogenation Catalytic hydrogenation of glucose or fructose
2 Purification Ion exchange, activated carbon treatment
3 Crystallization Cooling crystallization
4 Drying Vacuum drying
5 Packaging Packaged as powder or granules

Reaction:

Glucose + H₂ → Mannitol (Catalytic Hydrogenation)
C₆H₁₂O₆ + H₂ → C₆H₁₄O₆

SECTION 6: FOOD INDUSTRY APPLICATIONS (E421)

Application Function
Diet Products Low-calorie sweetener
Sugar-Free Products Sweetener, humectant
Chewing Gum Sweetener, humectant
Confectionery Sweetener, humectant
Nuts and Snacks Flavor enhancer, coating agent
Anti-Caking Agent Prevents caking (anti-caking agent)
Flavor Enhancer Flavor enhancer and sweetener
Diabetic Foods Low glycemic index sweetener
Freezing Point Depressant Lowers freezing point in foods
Crystallization Inhibitor Prevents crystallization

SECTION 7: PHARMACEUTICAL AND MEDICAL APPLICATIONS

Application Function
Chewable Tablets Non-hygroscopic nature makes it a primary component
Medicated Chewing Gum Sweetening agent
Brain and Eye Edema Used in medications for edema treatment
Diuretic Drugs Increases urine production
Kidney Failure Removes toxins and excess water
Osmotic Diuretic As osmotic diuretic (Osmitrol®)
Liquid Formulations Sweetener, stabilizer
Tablet Binder Binder in tablet formulations
Controlled Release Systems Binder and filler material

SECTION 8: INDUSTRIAL APPLICATIONS

Application Function
Antifreeze Production In sugar alcohol group (mannitol, sorbitol, maltitol)
Freezing Point Depressant Lowers freezing point by increasing water activity and crystallization inhibition
Vehicle Engine Additives Anti-wear additive (with monoethylene glycol in small amounts)
Cosmetics Moisturizer, stabilizer
Plastics and Polymers Plasticizer

SECTION 9: COMPARISON WITH OTHER SWEETENERS

Property Mannitol (E421) Sorbitol (E420) Sucrose Xylitol
Sweetness (Sucrose=100) ~50-60 ~60 100 ~100
Calories (kcal/g) ~2.5 2.6 4.0 2.4
Hygroscopicity Low High Low Medium
Dental Health Non-cariogenic Non-cariogenic Cariogenic Non-cariogenic
Water Solubility 216 g/L 220 g/L 2000 g/L 640 g/L
Melting Point 168 °C 111 °C 186 °C 95 °C

SECTION 10: QUALITY SPECIFICATIONS (FOOD GRADE)

Parameter Specification (USP / Ph. Eur. / FCC)
Appearance White, crystalline powder or granules
Identification Positive (Mannitol tests)
Assay (on dried basis) 98.0 – 102.0%
Loss on Drying ≤ 0.5%
Residue on Ignition ≤ 0.1%
pH (5% solution) 5.0 – 7.0
Chlorides (Cl) ≤ 0.005%
Sulfates (SO₄) ≤ 0.01%
Heavy Metals (as Pb) ≤ 10 ppm
Lead (Pb) ≤ 2 ppm
Arsenic (As) ≤ 3 ppm
Mercury (Hg) ≤ 1 ppm
Nickel (Ni) ≤ 1 ppm
Reducing Sugars ≤ 0.1%
Total Sugars ≤ 0.5%
Specific Rotation [α]D²⁰ +23° to +25°

SECTION 11: MICROBIOLOGICAL SPECIFICATIONS

Parameter Specification
Total Aerobic Mesophilic Bacteria ≤ 1,000 CFU/g
Yeast and Mold ≤ 100 CFU/g
Salmonella spp. Negative in 25g
Escherichia coli Negative in 10g

SECTION 12: STORAGE AND SHELF LIFE

Parameter Information
Storage Conditions Cool (15-25°C), dry, well-ventilated area
Container Requirements Tightly closed, original packaging
Protect From Moisture, strong oxidizing agents, strong acids
Shelf Life 24-60 months (unopened original packaging)
Stability Note Non-hygroscopic; does not cake in humid conditions

SECTION 13: PACKAGING OPTIONS

Packaging Type Quantity Material
PE-lined kraft paper bag 25 kg Kraft paper + PE
Plastic pail 20-25 kg HDPE
Aluminum foil bag 1-5 kg Laminated aluminum
Fiber drum 25-50 kg HDPE + PE
Big-Bag 500-1000 kg Polypropylene

SECTION 14: SAFETY AND HEALTH INFORMATION

GHS Classification (Bulk Powder)

Hazard Class Category
Not classified as hazardous -

Hazard Statements

Code Statement
None Not classified as hazardous

Precautionary Statements

Code Statement
P261 Avoid breathing dust
P280 Wear protective gloves/eye protection
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 15: TOXICOLOGICAL INFORMATION

Parameter Value
Oral LD50 (Rat) > 15,000 mg/kg
ADI (Acceptable Daily Intake) Not specified (JECFA)
Carcinogenicity Not classified
Mutagenicity Negative in standard tests
Reproductive Toxicity No evidence of adverse effects
FDA GRAS 21 CFR 180.30
Laxative Effect May cause osmotic diarrhea at high doses

SECTION 16: 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.
Eye Contact Rinse immediately with plenty of water for at least 15 minutes. Seek medical attention.
Ingestion Rinse mouth. Drink plenty of water. Seek medical attention.

SECTION 17: REGULATORY STATUS

Region / Authority Status
European Union Approved as E421
USA (FDA) GRAS (21 CFR 180.30)
Turkey Approved (Turkish Food Codex)
JECFA (FAO/WHO) Approved; ADI: Not specified
Codex Alimentarius Approved (INS 421)
USP Monograph available
Ph. Eur. Monograph available
FCC Monograph available

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 Combustible organic solid
Suitable Extinguishing Media Water spray (mist), CO₂, dry chemical powder
Specific Hazards When heated, emits CO, CO₂
Decomposition Products 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; landfilling at licensed facilities

SECTION 21: OTHER NAMES AND SYNONYMS

Type Name
Turkish Names Mannitol, Manna Şekeri, Deniz Kristali, Kordisepik Asit
English Names Mannitol, D-Mannitol, Osmitrol, Manna Sugar
Chemical Names (2R,3R,4R,5R)-Hexane-1,2,3,4,5,6-hexol
Trade Names Osmitrol®, Osmofundin®, Maniton-S®
E Number E421
CAS Number 69-65-8
EC Number 200-711-8
INCI Mannitol

SECTION 22: SUMMARY AND CRITICAL NOTES

Product Summary

Parameter Value
Product Mannitol
CAS Number 69-65-8
E Number E421
Appearance White, crystalline powder or granules
Molecular Weight 182.17 g/mol
Sweetness 50-60% of sucrose
Calories ~2.5 kcal/g
Primary Function Sweetener, humectant, anti-caking agent

Critical Notes

  1. Sugar Alcohol: Mannitol is a sugar alcohol (polyol) obtained by catalytic hydrogenation of glucose or fructose.

  2. Low Hygroscopicity: Unlike sorbitol and other sugar alcohols, mannitol is non-hygroscopic, making it a preferred ingredient in chewable tablets.

  3. Non-Cariogenic: Does not promote tooth decay; used in sugar-free chewing gum and oral care products.

  4. Osmotic Diuretic: Used in medicine for brain and eye edema treatment, and for toxin removal in kidney failure.

  5. Laxative Effect: May cause osmotic diarrhea at high doses; gastrointestinal tolerance should be considered.

  6. Naturally Occurring: Found naturally in fruits, vegetables, and mushrooms.

  7. Wide Applications: Used in food, pharmaceutical, cosmetic, and industrial applications.

  8. FDA GRAS: Approved as GRAS by FDA (21 CFR 180.30).

  9. Industrial Uses: Used in antifreeze production, as freezing point depressant, and as anti-wear additive in vehicle engines.

  10. Versatility: Serves as sweetener, humectant, anti-caking agent, filler, and osmotic diuretic across multiple industries.

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.

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