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Product Name: Metformin Hydrochloride
SYNONYMS: N,N-dimethylimidodicarbonimidic diamide hydrochloride; 1,1-dimethylbiguanide hydrochloride
CAS Number: 1115-70-4
Recommended Use: Antidiabetic agent for oral administration
Manufacturer Information: Pharmaceutical manufacturers, laboratory suppliers, emergency contact as per local regulation
Hazard Class: Not classified as hazardous under GHS
Hazard Statements: May cause irritation to eyes, skin, and respiratory tract upon prolonged or repeated exposure
Precautionary Statements: Avoid breathing dust, use adequate ventilation, handle with gloves and eye protection
Pictograms: No mandatory hazard pictogram
Other Hazards: Prolonged contact may trigger allergic reaction in sensitive individuals
Chemical Name: Metformin Hydrochloride
Concentration: ≥98% (pharmaceutical grade)
Molecular Formula: C4H11N5·HCl
Molecular Weight: 165.63 g/mol
Impurities: Trace residual solvents and related compounds as per manufacturing specifications
Inhalation: Move individual to fresh air, seek medical attention if symptoms persist, monitor for labored breathing
Skin Contact: Wash thoroughly with soap and water, remove contaminated clothing, seek medical attention if irritation develops
Eye Contact: Immediately rinse with water for at least 15 minutes, keep eyelids open, obtain medical advice if discomfort remains
Ingestion: Rinse mouth, seek immediate medical attention, do not induce vomiting unless instructed by medical professional
Suitable Extinguishing Media: Use water spray, dry chemical, foam, or carbon dioxide for small fires
Unsuitable Media: Avoid high-pressure water jets which may spread product
Specific Hazards: May emit toxic fumes like nitrogen oxides, carbon monoxide, and hydrogen chloride under combustion
Protective Equipment: Firefighters should wear self-contained breathing apparatus and full protective gear
Precautions: Prevent runoff from entering waterways to minimize environmental impact
Personal Precautions: Evacuate unnecessary personnel, avoid dust formation, provide adequate ventilation, use recommended PPE
Environmental Precautions: Avoid product entering drains, surface waters, and soil
Methods for Containment: Sweep up carefully without generating dust, place in suitable container for disposal, clean spill area with water
Disposal: Dispose of in accordance with local, regional, and national regulations, prevent from entering environment uncontrolled
Handling: Only trained personnel should handle the product using gloves, lab coats, eye shields; keep away from food and drink; minimize dust generation and accumulation
Storage: Store in tightly closed containers at controlled room temperature (15-30°C); keep away from strong oxidizers and moisture; avoid direct sunlight
Special Storage Requirements: Dedicated pharmaceutical storage security, do not store with incompatible substances
Occupational Exposure Limits: Not officially established for metformin hydrochloride; use common laboratory hygiene standards
Engineering Controls: Use local exhaust ventilation to maintain airborne levels below standard; hand washing facilities should be available
Personal Protective Equipment: Protective gloves (nitrile or latex), chemical safety goggles, lab coat, in case of risk of dust, use NIOSH-approved respirator
Other Protection: Emergency eye-wash stations and safety showers accessible in immediate area
Appearance: White to off-white crystalline powder
Odor: Odorless
pH (1% solution): 6.5–7.5
Solubility: Freely soluble in water, practically insoluble in ethanol and acetone
Melting Point: Decomposes above 223°C
Boiling Point: Not available (decomposes before boiling)
Vapor Pressure: Negligible at room temperature
Partition Coefficient (Log Pow): -2.6
Relative Density: 1.3 g/cm³
Chemical Stability: Stable under recommended storage and handling conditions
Reactivity: No dangerous reactions known under normal conditions
Incompatible Materials: Strong oxidizing agents, strong bases
Hazardous Decomposition Products: Nitrogen oxides, carbon oxides, hydrogen chloride may form
Polymerization: Product does not polymerize
Acute Toxicity: Low oral toxicity; LD50 (rat, oral): 2000 mg/kg
Irritation: May cause mild mucous membrane or eye irritation
Chronic Exposure: Repeated large doses can lead to lactic acidosis, more likely in individuals with preexisting kidney or liver dysfunction
Sensitization: Not expected, but rare hypersensitivity reported
Other Effects: Nausea, abdominal discomfort, diarrhea may occur at therapeutic dose
Carcinogenicity/Mutagenicity/Reproductive Toxicity: Not listed as carcinogen by IARC, NTP, or OSHA; negative in standard mutagenicity tests; no evidence of fetal effects at human therapeutic levels
Environmental Fate: Rapid and complete removal in municipal sewage treatment systems, limited persistence in soil and water
Toxicity to Aquatic Life: Low acute toxicity, LC50 (fish, 96h): >100 mg/L
Bioaccumulation: Not expected because of high water solubility and low log Pow
Mobility in Soil: Readily mobile in moist conditions, minimal bioaccumulation
Other Adverse Effects: Release large volumes only with regulatory notification, encourage pharmaceuticals take-back programs for safe disposal
Waste Treatment Methods: Collect and place in sealed, labelled containers for incineration or landfill at approved facility
Unused or Expired Product: Return to pharmacy or hazardous waste collection center for destruction
Contaminated Packaging: Triple rinse and dispose of according to regional regulations
Disposal Precautions: Prevent product and rinsate from entering drains, sewers, bodies of water or soil
UN Number: Not regulated for transport
Transport Hazard Class: Not classified as a dangerous good
Packing Group: Not applicable
Marine Pollutant: No
Special Precautions for Transport: Keep packaging intact, avoid moisture, protect from damage during shipment, label shipment containers with identity and hazard information
US Regulations: Not listed as a hazardous substance by the EPA; non-controlled under DEA status; OSHA hazard communication standard applies
EU Regulations: Not classified as hazardous according to EC 1272/2008 (CLP); REACH registration exemptions for pharmaceuticals
Other International Regulations: Included on WHO Model List of Essential Medicines; compliance with individual country pharmaceutical regulations required
Labeling Requirements: Provide product name, manufacturer, hazard information, batch and expiry, emergency contact on label
Workplace Registration: Material must be listed on relevant chemical inventories where used, secure storage and handling records kept per state and federal law
