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Product Name: Sorbitol – Injection Grade
Synonyms: D-sorbitol, Glucitol
CAS Number: 50-70-4
EC Number: 200-061-5
Recommended Use: Pharmaceutical excipient, osmotic diuretic, sweetener for parenteral formulations
Supplier: Refer to local distributor
Emergency Contacts: National Poison Center, local authorities, company safety desk
GHS Classification: Not classified as hazardous under GHS
Hazard Statements: Product does not present an inhalation, ingestion, or dermal toxicity risk under normal use; may cause mild irritation in sensitive individuals
Signal Word: None
Pictogram: None
Routes of Exposure: Eyes, skin, ingestion, inhalation
Health Effects: Mild gastrointestinal upset if consumed in high quantities, possible temporary irritation to skin or eyes
Chemical Name: Sorbitol
Concentration: ≥ 98%
Other Ingredients: Water for injection (if in solution), trace impurities possible depending on manufacturer
Impurities: Tested to comply with pharmacopoeial standards; low levels of mannitol, other sugar alcohols possible
Eye Contact: Rinse immediately with plenty of clean, lukewarm water for several minutes; seek medical attention if irritation persists
Skin Contact: Wash with mild soap and water; remove contaminated clothing if needed
Inhalation: Move to fresh air; consult a physician if respiratory symptoms develop
Ingestion: Rinse mouth; drink water if large amounts ingested; consult a doctor if significant discomfort or symptoms occur
Suitable Extinguishing Media: Dry chemical, foam, carbon dioxide, water spray
Unsuitable Media: None known
Special Hazards: Emits carbon oxides if combusted
Protective Equipment: Firefighters wear self-contained breathing apparatus and full protective gear to prevent exposure to combustion products
Personal Precautions: Wear appropriate personal protective equipment to avoid skin or eye contact
Environmental Precautions: Prevent entry into drains or waterways
Cleanup Methods: Absorb spillage with suitable material (e.g., sand, inert powder), collect in container for disposal according to regulations, ventilate area thoroughly
Handling: Minimize dust generation; avoid contact with eyes and skin; use proper protective equipment
Storage: Keep product in tightly closed container in dry, cool, well-ventilated room away from incompatible materials, moisture, and heat sources
Storage Temperature: 15 – 25°C for solid form, 2 – 8°C for solution
Incompatible Materials: Strong oxidizing agents, acids
Exposure Limits: No established occupational exposure limits for sorbitol
Engineering Controls: Work in well-ventilated area; local exhaust preferred where dust is generated
Personal Protective Equipment: Safety goggles, laboratory coat, gloves made of compatible material (e.g., nitrile); in situations with high dust, use dust mask or respirator
Hygiene Measures: Wash hands after handling and before eating, drinking, or smoking; do not eat, drink, or smoke in work areas
Physical State: Solid crystalline powder or aqueous solution
Color: White
Odor: Odorless
Solubility: Freely soluble in water
pH (50% solution): 5.0 – 7.0
Melting Point: 95 – 100°C
Boiling Point: Decomposes before boiling
Vapor Pressure: Negligible
Bulk Density: 1.49 g/cm³
Chemical Stability: Stable under normal storage and handling
Conditions to Avoid: Excess heat, moisture
Materials to Avoid: Oxidizing agents, strong acids
Decomposition Products: Carbon dioxide and carbon monoxide under combustion
Acute Toxicity: Low oral toxicity (LD50 oral, rat: >16,000 mg/kg)
Chronic Toxicity: No significant chronic effects or carcinogenicity reported
Routes of Exposure: Skin, eyes, ingestion
Symptoms of Overexposure: Gastrointestinal upset including diarrhea and cramping if large amounts ingested
Irritation: No significant skin or eye irritation in normal pharmaceutical use
Mutagenicity/Carcinogenicity: Not listed by IARC, NTP, OSHA as carcinogenic or mutagenic
Ecotoxicity: Not classified as hazardous to aquatic environment; low risk in typical pharmaceutical applications
Persistence and Degradability: Biodegradable; rapidly metabolized by soil microflora
Bioaccumulation: Low potential for bioaccumulation
Mobility in Soil: Mobile in aqueous environment due to water solubility
Waste Treatment Methods: Dispose of in accordance with local, regional, and national regulations
Contaminated Packaging: Triple-rinse and offer for recycling or dispose of according to local guidelines
Disposal of Spills/Unused Product: Absorb liquid with inert materials, sweep up solids; avoid release to environment
Special Disposal Notice: Avoid disposal to surface water or sewers
UN Number: Not regulated as a dangerous good
Proper Shipping Name: Sorbitol – Injection Grade
Transport Hazard Class: Not classified as hazardous
Packing Group: Not applicable
Environmental Hazards: Not a marine pollutant
Special Precautions: Protect from physical damage, keep container tightly closed
Inventory Listings: Listed in US TSCA, EINECS/ELINCS, Canada DSL, and other major inventories
Regulatory Status: Approved for pharmaceutical and food applications according to US FDA and EU regulations
Labelling Requirements: No special labelling required for pharmaceutical or food grade under GHS
Restriction Information: Observe all local, national, and international regulations related to use, handling, and disposal
Workplace Regulations: Observe occupational safety standards that may be set locally
Additional Notes: Refer to current guidelines for pharmaceutical excipients, including US Pharmacopeia (USP) and European Pharmacopoeia (Ph. Eur.)
