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Product Name: Pioglitazone Hydrochloride
Chemical Formula: C19H20N2O3S·HCl
CAS Number: 112529-15-4
Synonyms: 5-[[4-[2-(5-Ethyl-2-pyridinyl)ethoxy]phenyl]methyl]-2,4-thiazolidinedione hydrochloride
Recommended Use: Used as an oral antidiabetic agent in the management of type 2 diabetes mellitus
Supplier Information: Include manufacturer’s name, contact address, phone number, and emergency contact
Emergency Contact: Local emergency number and poison control hotline
Classification: May cause respiratory tract, eye, and skin irritation; can be harmful if swallowed; not classified as flammable, carcinogenicity possible based on animal studies
GHS Label Elements: Exclamation mark symbol; “Warning” signal word
Hazard Statements: Causes mild skin irritation, may cause respiratory irritation, harmful if inhaled or swallowed
Precautionary Statements: Avoid breathing dust or fumes, wear protective gloves, protect eyes and skin, wash thoroughly after handling
Other Hazards: Fine dust may form explosive mixtures in air; avoid sources of ignition
Substance: Pioglitazone Hydrochloride
Purity: Typically greater than 99% active pharmaceutical ingredient
Impurities: Trace organic or inorganic impurities as specified by pharmacopeia
Additional Components: No hazardous non-active additives present
Molecular Weight: 392.90 (free base); 428.94 (hydrochloride salt)
Inhalation: Remove person to fresh air, monitor breathing, seek medical advice if symptoms develop
Ingestion: Rinse mouth with water, do not induce vomiting unless directed by medical personnel, get medical attention if symptoms persist
Skin Contact: Remove contaminated clothing, rinse skin thoroughly with soap and water, medical advice recommended in case of irritation
Eye Contact: Flush eyes gently with water for at least 15 minutes, hold eyelids open, obtain medical attention if irritation continues
Important Symptoms: Coughing, nausea, respiratory discomfort, eye redness, skin dryness
Suitable Extinguishing Media: Use water spray, carbon dioxide, dry chemical powder, or foam
Special Hazards: Combustion releases toxic fumes, including nitrogen oxides, sulfoxides, hydrogen chloride
Protective Equipment: Firefighters should use self-contained breathing apparatus and full protective gear
Advice for Firefighters: Move uninvolved persons away from area, cool adjacent containers, prevent water runoff
Personal Precautions: Wear recommended PPE, avoid breathing dust, ventilate area
Environmental Precautions: Prevent entry into waterways, drains, or soil
Methods for Containment: Sweep up material carefully, avoid dust generation, place in suitable container for disposal
Methods for Cleaning Up: Use HEPA filter vacuum or damp method, wash spill site after clean-up
Precautions for Safe Handling: Keep away from sources of ignition, avoid contact with skin and eyes, prevent dust buildup, handle under local exhaust ventilation
Conditions for Safe Storage: Store in tightly closed containers, away from light and moisture; maintain temperature at 2–8°C unless otherwise stated
Storage Incompatibilities: Store away from strong oxidizers, acids, and bases; avoid mixing with incompatible chemicals
Specific End Use: Only trained personnel should handle bulk material or perform laboratory work
Occupational Exposure Limits: No established OSHA or ACGIH exposure limits; minimize exposure by technical means
Engineering Controls: Use fume hoods, local exhaust ventilation, contain processes generating dust
Personal Protective Equipment: Wear lab coats, chemical resistant gloves, safety goggles, approved respirator for dust exposure
Hygiene Measures: Wash hands before breaks and after work, do not eat or drink in work area, remove contaminated clothing on leaving lab
Appearance: White to off-white crystalline powder
Odor: Odorless or very faint
Melting Point: Approximately 193–196°C, decomposition above this temperature
Boiling Point: Not available (decomposes)
Solubility: Soluble in dimethyl sulfoxide and slightly soluble in water
Density: 1.3–1.4 g/cm³ estimated
pH (1% Solution): 4–6
Partition Coefficient (log Kow): 2.3 (approximate)
Other Properties: Stable under normal handling and storage
Chemical Stability: Stable at room temperature and under recommended conditions
Possibility of Hazardous Reactions: May react with strong oxidizers, strong acids, and bases
Conditions to Avoid: Strong heat, moisture, direct sunlight
Hazardous Decomposition Products: Emits toxic gases upon decomposition, such as NOx, SOx, and HCl
Incompatible Materials: Avoid mixing with strong oxidizing agents
Routes of Exposure: Inhalation, ingestion, skin, and eyes
Acute Toxicity: LD50 (oral, rat): >2000 mg/kg; low acute toxicity in animal models
Chronic Effects: Prolonged exposure may affect liver function and increase cancer risk (based on long-term animal studies)
Symptoms: Nausea, dizziness, allergic skin reactions, eye irritation
Carcinogenicity: Not classified as carcinogenic by IARC but some studies raise concerns about bladder tumors in rodents
Other Effects: May cause mild changes in blood count with repeated exposure
Ecotoxicity: Harmful to aquatic organisms at high concentrations, low bioaccumulation potential
Mobility in Soil: Moderately mobile; potential to reach ground and surface water
Persistence and Degradability: Moderately persistent in environment, slow degradation in soil and water
Bioaccumulation: Low based on partition coefficient
Other Adverse Effects: No data on ozone depletion, global warming, or photochemical ozone creation potential
Disposal Methods: Incinerate in an approved chemical incinerator with afterburner and scrubber, or dispose through licensed waste management company
Contaminated Packaging: Decontaminate and recycle or dispose as hazardous waste
Special Precautions: Do not discharge into sewer, surface, or groundwater
Regulatory Requirements: Comply with local, national, and international regulations on pharmaceutical waste
UN Number: Not classified as dangerous goods under UN, IATA, or IMDG regulations
Proper Shipping Name: Pioglitazone Hydrochloride
Packing Group: Not assigned
Transport Hazard Class: None
Environmental Hazards: Not a marine pollutant
Special Precautions: Secure packaging to prevent breakage during transport
Safety, Health and Environmental Regulations: Listed on relevant chemical inventories such as EINECS/EC, TSCA, DSL/NDSL
OSHA: No specific standards, handle as hazardous drug
EPA: Not specifically regulated; observe pharmaceutical waste guidance
WHMIS: Not classified
REACH: Meets criteria for registration, manufacturer and importer obligations apply
Other: Observe national occupational safety regulations concerning handling hazardous pharmaceuticals
