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Product Name: Miglitol
Chemical Formula: C8H17NO5
Chemical Name: (2R,3R,4R,5S)-1-(2-Hydroxyethyl)-2-(hydroxymethyl)piperidine-3,4,5-triol
CAS Number: 72432-10-1
Recommended Use: Oral antihyperglycemic for Type 2 Diabetes
Supplier: Identify the manufacturer or distributor with address and contact information
Emergency Phone Number: Local emergency or poison help contact
GHS Classification: Not considered hazardous under standard criteria
Label Elements: No pictogram, signal word, or hazard statement required
Hazards: May cause mild skin or eye irritation in sensitive individuals, rare occurrences of allergic skin response. Ingestion intended for therapeutic use but accidental large exposure can result in adverse gastrointestinal effects, including abdominal pain, diarrhea, or flatulence.
Physical Hazards: No known significant physical hazards
Environmental Hazards: Low bioaccumulation potential and minimal aquatic toxicity known
Chemical: Miglitol
Concentration: 100% (pure substance, for bulk pharma grade)
Synonyms: Glyset, N-Hydroxyethyl-1-deoxynojirimycin
Impurities: Low-level residual solvents may be present in technical grade material, full impurity profile available on request
Inhalation: Move to fresh air, monitor for symptoms including dizziness, headache, or difficulty breathing; seek medical attention for persistent discomfort
Eye Contact: Rinse thoroughly with plenty of water for at least 15 minutes; remove contact lenses if present and easy to do; seek medical attention for irritation
Skin Contact: Wash off with water and soap; consult a physician if skin reactions develop
Ingestion: Rinse mouth with water, seek immediate medical attention if large quantities ingested or severe symptoms appear; do not induce vomiting unless directed by medical personnel
Suitable Extinguishing Media: Water spray, dry chemical, carbon dioxide, or alcohol-resistant foam
Special Hazards: Decomposition can produce carbon oxides and nitrogen oxides under intense heat
Protective Equipment for Firefighters: Self-contained breathing apparatus and protective clothing required
Additional Information: Avoid breathing dust, fumes, or combustion gases; cool containers with water if exposed to flames
Personal Protective Equipment: Safety goggles, chemical-resistant gloves, lab coat, dust mask where adequate ventilation is not available
Precautions: Avoid dust buildup or dispersion into the air
Spill Cleanup: Sweep up powder without generating dust, collect in a sealable container for disposal; wash contaminated surfaces with water
Environmental Precautions: Do not flush into sewers or waterways; minimize environmental release
Handling: Work in well-ventilated areas, avoid contact with skin, eyes, and clothing; avoid inhalation of powder
Storage: Store in tightly closed containers, in a dry, cool, well-ventilated place; keep separate from incompatible substances such as strong acids and oxidizers
Precautions: Prevent container damage, label clearly, keep out of reach of children and unauthorized personnel
Exposure Limits: No specific occupational exposure limits established; general workplace dust guidelines apply
Ventilation: Use local exhaust or general dilution ventilation to minimize dust exposure
Respiratory Protection: Use NIOSH-approved respirator as needed
Skin Protection: Latex or nitrile rubber gloves
Eye Protection: Chemical safety goggles
Other Protection: Laboratory coat or apron, boots in case of bulk handling
Hygiene Measures: Wash hands thoroughly after handling; do not eat, drink, or smoke when handling this product
Appearance: White to off-white crystalline powder
Odor: Odorless
pH: 5.0-7.5 (1% aqueous solution)
Melting Point: 128–133 °C
Boiling Point: Not applicable (decomposes before boiling)
Flash Point: Not flammable
Solubility: Water soluble
Partition Coefficient (log Pow): -2.9 (indicative of high water solubility, low lipid solubility)
Vapor Pressure: Negligible
Relative Density: 1.5 g/cm³
Other Properties: Stable under normal storage conditions, low volatility
Chemical Stability: Stable at room temperature in dry, sealed containers
Reactivity: No hazardous reactions known under recommended conditions
Conditions to Avoid: Excessive heat, prolonged moisture exposure
Incompatible Materials: Strong oxidizing agents, strong acids
Hazardous Decomposition Products: Nitrogen oxides, carbon monoxide, carbon dioxide under fire conditions
Acute Toxicity: Low oral toxicity; therapeutic doses in humans start at 25 mg, toxicity unlikely except in large overdose
Skin Corrosion/Irritation: Non-irritating to skin in animal and human studies
Serious Eye Damage/Irritation: Mild and reversible eye irritation possible
Respiratory Sensitization: No evidence of respiratory sensitization
Carcinogenicity: Not classified as a carcinogen by IARC, NTP, or OSHA
Reproductive Toxicity: No evidence found in animal studies for reproductive or developmental toxicity
Other Effects: May produce transient gastrointestinal symptoms at therapeutic doses; no significant chronic effects reported in clinical use
Ecotoxicity: Minimal aquatic toxicity at expected exposure levels
Persistence and Degradability: Expected to be readily biodegradable in wastewater treatment
Bioaccumulation Potential: Very low due to high water solubility and low partition coefficient
Mobility in Soil: Expected to move with water due to solubility
Other Adverse Effects: Not identified as a significant environmental hazard; no evidence of long-term biohazard effects in the ecosystem
Waste Disposal Methods: Dispose of surplus and non-recyclable solutions through a licensed chemical waste disposal contractor.
Contaminated Packaging: Containers or packaging contaminated with Miglitol should be treated as hazardous chemical waste. Rinse with water, then dispose under local regulations.
Legal Requirements: Follow all applicable federal, state, and local environmental regulations for disposal
UN Number: Not regulated as a hazardous material for transport
Proper Shipping Name: Miglitol
Transport Hazard Class: Not classified
Packing Group: Not applicable
Marine Pollutant: No
Special Transport Precautions: Keep containers securely sealed and dry during transport; use standard trucking precautions for bulk powders
OSHA Status: Not hazardous according to OSHA Hazard Communication Standard
TSCA Status: Listed
EU Regulations: Not classified as hazardous under Regulation (EC) No 1272/2008 (CLP)
WHMIS Classification: Not controlled product
Other Regulation: Drug approved for oral use in Type 2 diabetes under various national guidelines, shipments must comply with pharmaceutical handling requirements and local regulation
