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Product Name: Atorvastatin Calcium
Chemical Formula: (C33H34FN2O5)2Ca·3H2O
CAS Number: 134523-03-8
Intended Use: Pharmaceutical manufacturing, cholesterol-lowering agent
Supplier: Pharmaceutical manufacturer, research laboratories
Contact Information: Manufacturer’s emergency phone and address (found on package insert)
Hazard Classification: Not classified as hazardous by GHS criteria for pure substances
Risk Phrases: May cause skin and eye irritation; possible ingestion hazards
Routes of Exposure: Inhalation, skin contact, eye contact, ingestion
Target Organs: Liver, digestive tract, skin
Signal Word: Warning
Health Risks: Prolonged exposure can affect hepatic function; allergic reactions reported
Environmental Hazards: Potential harmful effects if released into aquatic systems
Chemical Name: Atorvastatin Calcium Trihydrate
Molecular Weight: 1209.45 g/mol
Percentage Purity: >98% active pharmaceutical ingredient
Impurities: Trace solvents, synthesis byproducts <0.5%
Other Ingredients: None in pure substance form
Inhalation: Move affected individual to fresh air, monitor for symptoms; seek medical attention for persistent irritation
Skin Contact: Remove contaminated clothing, wash thoroughly with soap and water; seek help if irritation persists
Eye Contact: Rinse eyes cautiously with plenty of water for at least 15 minutes, remove contact lenses if present and easy to do, consult physician if necessary
Ingestion: Rinse mouth with water, do not induce vomiting; seek prompt medical care if discomfort or adverse effects occur
Suitable Extinguishing Media: Dry chemical powder, foam, carbon dioxide, water spray
Unsuitable Extinguishing Media: Direct water jet (risk of spreading powder/dust)
Specific Fire Hazards: Combustion generates toxic fumes of carbon oxides, nitrogen oxides, and possibly fluorine-containing compounds
Protective Equipment: Firefighters need self-contained breathing apparatus (SCBA) and full protective gear
Firefighting Instructions: Contain fire water runoff, avoid breathing smoke or fumes
Personal Precautions: Wear gloves, eye protection, dust mask or respirator if airborne
Environmental Precautions: Stop release into drains, surface water, or soil
Clean-up Methods: Sweep up or vacuum spilled powder, avoid creating dust, place in labeled container for disposal; ventilate area and wash spill site after material pickup
Disposal: Follow local regulations for pharmaceutical waste
Handling: Use in well-ventilated areas, handle with appropriate personal protective equipment, prevent inhalation or skin contact, avoid dust generation
Hygiene Measures: Wash hands, forearms, face after handling, do not eat, drink, or smoke around substance
Storage Conditions: Keep container tightly closed, store in cool, dry place away from incompatible substances, protect from light and moisture
Incompatibilities: Strong oxidizers, acids, bases
Occupational Exposure Limits: No established OSHA/ACGIH limits for atorvastatin calcium
Engineering Controls: Laboratory fume hood, local exhaust ventilation
Personal Protective Equipment (PPE): Chemical-resistant gloves (nitrile), goggles or safety glasses, lab coat, dust mask or respirator in case of dust generation
Environmental Controls: Prevent dust and powder release into the environment
Appearance: White to off-white crystalline powder
Odor: Odorless
pH (1% Solution): Approximately 7
Melting Point: 159-160°C
Boiling Point: Not applicable (decomposes)
Flash Point: No data available
Solubility: Poorly soluble in water, more soluble in methanol and ethanol
Vapor Pressure: Not applicable (solid at room temperature)
Partition Coefficient (log P): 4.1
Chemical Stability: Stable under recommended storage and handling conditions
Decomposition Products: Carbon oxides, nitrogen oxides, possible fluoride-containing compounds under fire
Incompatibility: Strong acids, strong bases, oxidizing agents
Hazardous Polymerization: Does not occur
Conditions to Avoid: Moisture, direct sunlight, sources of ignition
Acute Toxicity: Low oral toxicity in animal studies; high doses may cause liver effects
Chronic Toxicity: Extended exposure may affect liver enzymes, possible allergic response in sensitized persons
Carcinogenicity: Not listed as carcinogen by IARC, NTP, OSHA
Mutagenicity: Negative in most in vitro and in vivo genetic toxicity tests
Reproductive Effects: Avoid during pregnancy and breastfeeding; possible fetal toxicity
Routes of Exposure: Eye irritation, skin redness, gastrointestinal discomfort
Ecotoxicity: Limited data; potential hazard to aquatic organisms, may disrupt microbial balance in sediment
Persistence and Degradability: Slowly degradable, may persist under certain environmental conditions
Bioaccumulation Potential: Low expected, but check local environmental reports
Mobility in Soil: Limited mobility; binds to organic material and soil
Additional Environmental Information: Uncontrolled release may present long-term hazards to aquatic life
Product Disposal: Incinerate in licensed chemical waste facility; avoid flushing into sewage
Container Handling: Destroy after emptying, follow local hazardous waste regulations
Unused Material: Collect for pharmaceutical waste or hazardous waste management
Local Regulations: Check regional, state, and national requirements specific to hazardous medical compounds
UN Number: Not classified as dangerous goods for transport
Transport Hazard Class: Not regulated (low risk under normal transport conditions)
Packing Group: Not assigned
Special Precautions: Use sealed, labeled containers; avoid mechanical impact
Environmental Hazards: Prevent accidental release during transit
Labeling Requirements: Complies with pharmaceutical labeling standards
GHS Precautions: Not hazardous under GHS but follow safe handling guidelines
Inventory Status: Listed in major international chemical inventories for pharmaceuticals
Other Regulations: Subject to FDA and EMA rules for pharmaceutical compounds; osmotic control, substance reporting may be required in local jurisdiction
