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Product name: Glimepiride
Chemical Formula: C24H34N4O5S
Synonyms: Amaryl, GLM, 1-[[p-[2-(3-ethyl-4-methyl-2-oxo-3-pyrroline-1-carboxamido)ethyl]phenyl]sulfonyl]-3-(trans-4-methylcyclohexyl)urea
CAS Number: 93479-97-1
Manufacturer: Listed on packaging, main suppliers include major pharma labs
Recommended Use: Pharmaceutical, antidiabetic agent
Contact Information: Manufacturer’s safety and support contact located on bulk container
Hazard Class: Not classified as acutely toxic or carcinogenic under standard regulatory criteria
Signal Word: Warning
Potential Health Effects: May cause respiratory tract, skin, and eye irritation, ingestion can provoke hypoglycemia
GHS Pictograms: Exclamation mark
Routes of Exposure: Inhalation, skin contact, eye contact, ingestion
Target Organs: Pancreas, blood glucose regulatory system
Emergency Overview: Do not handle without proper protection due to possible allergic and hypoglycemic response
Ingredient: Glimepiride
Concentration: >98% by weight
Impurities: Pharmaceutical batches are tightly controlled, may include trace residuals from synthesis
Other Components: Pharmaceutical formulations may include excipients intended to support compressibility and stability; refer to specific product insert for full list
Inhalation: Move person to fresh air, seek medical advice if symptoms persist
Skin Contact: Wash affected area thoroughly with soap and water, remove contaminated clothing
Eye Contact: Rinse with copious amounts of water for at least 15 minutes, consult physician
Ingestion: Seek medical attention immediately, do not induce vomiting unless directed by medical personnel
Antidotes: Supportive therapy and monitoring of blood glucose levels; treat hypoglycemia with glucose or intravenous dextrose if necessary
Extinguishing Media: Dry chemical, carbon dioxide, foam, or water spray; avoid using direct water jets
Hazardous Combustion Products: Emits toxic fumes of nitrogen oxides, sulfur oxides, and carbon oxides
Special Protective Equipment: Wear full firefighting turn-out gear and self-contained breathing apparatus
Specific Hazards: Dust can form explosive mixtures in air, handle powders with care
Thermal Decomposition: Risk of hazardous fume release if exposed to heat or flame
Personal Precautions: Wear appropriate protective equipment to prevent inhalation or skin contact
Spill Cleanup Methods: Scoop up and transfer spilled powder into a labeled waste container, clean spill area with damp cloth
Environmental Precautions: Avoid discharge to drains or watercourses; contain spill using absorbent materials
Disposal of Cleanup Materials: Handle as hazardous pharmaceutical waste; follow site protocols
Handling: Handle in well-ventilated areas, use local exhaust to reduce airborne concentrations; minimize generation of dust
Hygiene Measures: Wash hands thoroughly after handling, avoid eating, drinking, or smoking in work areas
Storage: Store in tightly closed original container, in a cool, dry place, away from incompatible substances
Incompatibles: Strong oxidizing agents, bases, direct sunlight
Packaging Materials: Use pharmaceutical-grade, moisture-resistant options as per regulatory spec
Exposure Limits: No official occupational limits; minimize exposure based on institutional controls
Engineering Controls: Work in fume hood or local exhaust, prevent disbursal of dust
Personal Protection: Nitrile or latex gloves, laboratory coat, safety goggles, possible particulate respirator if dust is visible
Environmental Controls: Monitor waste streams, implement precautions to avoid environmental contamination
Appearance: White to pale yellow crystalline powder
Odor: Odorless
Melting Point: 207–209°C
Boiling Point: Not applicable
Solubility: Poorly soluble in water, soluble in DMSO and slightly in methanol
Molecular Weight: 490.62 g/mol
pH: No significant change in water (insoluble)
Partition Coefficient (log P): Approximately 3.2
Vapor Pressure: Negligible at room temperature
Stability: Stable under recommended storage conditions
Chemical Stability: Stable under ambient conditions and in original packaging
Conditions to Avoid: Excess heat, moisture, direct sunlight
Incompatible Materials: Strong oxidizers, reducing agents
Decomposition Products: Toxic gases including NOx, SOx, CO, CO2
Polymerization: No hazardous polymerization expected
Acute Toxicity: LD50 (oral, rat): ~3000 mg/kg
Chronic Exposure: Long-term exposure might lower blood glucose levels excessively
Sensitization: Hypersensitivity reactions have occurred in clinical use
Carcinogenicity: Not classified as carcinogenic by IARC, NTP, OSHA
Mutagenicity: No evidence, based on animal studies and in vitro tests
Reproductive Effects: Not anticipated at occupational limits
Other Health Effects: Overexposure may impact glucose metabolism, especially in sensitive individuals
Aquatic Toxicity: Very little breaks down in wastewater treatment; chronic pollutants for algae and daphnia, minimal fish toxicity under normal conditions
Persistence / Degradability: Not readily biodegradable, risk of bioaccumulation exists
Mobility: Limited mobility in soil due to poor water solubility
Bioaccumulation: Unlikely to bioaccumulate significantly at low exposure levels
Other Adverse Effects: Should not enter environment in significant quantities, avoid spillage to surface waters
Waste Treatment Methods: Dispose of as hazardous pharmaceutical waste, follow local regulations
Contaminated Packaging: Treat packaging as hazardous—triple wash or incinerate according to national guidelines
Precautions: Do not release to sewage systems, minimize exposure to municipal waste personnel
UN Number: Not assigned for non-bulk transport
Transport Hazard Class: Not classified as dangerous under transport regulations
Packing Group: Not regulated for packaging
Special Precautions: Protect from physical damage during transit, avoid temperature extremes
Labeling: Use manufacturer’s labeling as per regulatory requirement for medicinal products
Regulatory Status: Schedule H in India, prescription only in EU, US, Canada
Safety Assessment: Approved for human consumption, restrictions apply for occupational exposure in some regions
Specific Regulations: Covered under REACH regulation in EU for chemical safety, FDA-listed in US
Hazard Communication: Employers must provide employee training and information under OSHA Hazard Communication Standard or national equivalent
