© 2026 Sinochem Nanjing Corporation,
All Right Reserved
Product Name: Pravastatin Sodium
Chemical Formula: C23H35NaO7
Synonyms: Pravachol, Mevalonolactone derivative
CAS Number: 81131-70-6
Recommended Uses: Pharmaceutical manufacturing, research
Supplier Details: Provided by licensed pharmaceutical distributors
Emergency Contact: Reach local poison control center or supplier emergency line for immediate response
Classification: Not classified as a hazardous substance by GHS criteria for the supplied form, but pharmaceutical ingredients may present specific health dangers during handling
Hazard Statements: May cause respiratory irritation, skin sensitization, eye irritation
Signal Word: Warning
Routes of Exposure: Inhalation, skin contact, eye contact, ingestion
Potential Health Effects: Sneezing, dry throat, mild skin redness, mild eye watering, nausea in case of ingestion
Precautionary Statements: Avoid breathing dust, use gloves to prevent skin exposure, keep away from eyes, do not eat or drink during handling
Chemical Name: Pravastatin Sodium
Concentration: 98-100% active pharmaceutical ingredient
Impurities: Hydration water (trace), sodium salts, process-related residues within pharmacopeial limits
Other Ingredients: No intentional additives, pure API substance
Molecular Weight: 446.52 g/mol
Eye Contact: Rinse eyes with water for 10–15 minutes while keeping eyelids open, seeking medical attention if irritation stays
Skin Contact: Wash contaminated skin with soap and water, remove contaminated clothing, seek help if itching or redness spreads
Inhalation: Move person to fresh air, assist breathing if coughing or throat tightness occurs, medical attention for prolonged symptoms
Ingestion: Rinse mouth, give water if conscious, do not induce vomiting, seek prompt medical advice
General Advice: Call poison center or emergency facility if symptoms are significant or person feels unwell
Suitable Extinguishing Media: Water spray, dry chemical powder, carbon dioxide, foam
Unsuitable Extinguishing Agents: High-pressure water jets that may aerosolize fine powder
Specific Hazards: Combustion may form toxic fumes such as carbon oxides, nitrogen oxides, and sodium compounds
Protective Equipment: Firefighters wear self-contained breathing apparatus and protective gear against pharmaceutical dusts
Special Procedures: Contain runoff to prevent carrying active pharmaceutical agents to drains
Personal Safety: Put on disposable gloves, safety goggles, dust mask or respirator
Environmental Protection: Prevent entry into sewage systems, surface water, or soil
Containment: Remove sources of ignition; gently sweep up product, avoiding dust formation
Cleanup: Pick up powder with damp cloth or absorbent material, discard as hazardous waste, ensure cleanup staff use adequate protection
Decontamination: Wash area thoroughly with water and detergent to prevent residue buildup and future exposure
Handling: Work in well-ventilated space, avoid inhaling dust, do not eat or drink during handling, wash hands when finished
Storage Conditions: Store in original containers, away from sunlight, moisture, and incompatible substances such as strong acids or oxidizers
Temperature Requirements: Maintain storage temperatures below 30°C, avoiding freeze/thaw cycles
Packaging Materials: Use sealed, moisture-resistant, and pharmaceutical-grade packaging
Incompatibilities: Keep apart from strong oxidants, reducing agents, and acids that could degrade the compound
Exposure Limits: No occupational exposure limits established for pravastatin sodium, handle as an active pharmaceutical ingredient (API), minimize all exposures
Engineering Controls: Use local exhaust ventilation or fume hoods for large-scale operations
Personal Protection: Use nitrile gloves, laboratory coats, chemical splash goggles, and dust-filter masks or respirators in dusty environments
Hygiene Measures: Carefully wash hands and forearms after use, keep work clothing separate from street clothing, perform routine cleaning of surfaces and workspaces
Monitoring Methods: Periodic air sampling in production environments as part of a broader safety protocol for potent compounds
Appearance: White to off-white crystalline powder
Odor: Odorless
Odor Threshold: Not established
Solubility: Soluble in water, ethanol; sparingly soluble in acetonitrile and methanol
Melting Point: 105–120°C
Decomposition Temperature: Starts breaking down above 150°C with an acrid odor
pH (1% solution): Around 7–9
Vapor Pressure: Negligible at room temperature
Density: 1.3–1.5 g/cm³
Partition Coefficient (log P): Estimated at 0.6, lends itself to moderate water solubility
Stability: Remains stable under recommended storage and handling practices
Environmental Sensitivity: Degrades in strong light, high temperature, and exposure to moisture
Reactivity: Reacts with acidic and strong oxidizing agents to form degradation products
Hazardous Decomposition Products: Carbon oxides, nitrogen oxides, sodium compounds on thermal decomposition
Polymerization: No polymerization hazards observed, basic chemical nature does not promote self-reaction
Acute Toxicity: Oral LD50 in rodents above 2,000 mg/kg, low risk with acute accidental exposure
Chronic Effects: Prolonged exposure in animal studies links to liver enzyme elevations and muscle aches
Irritation: Mild irritant to eyes and skin, dust can irritate mucus membranes
Sensitization: Potential risk for developing allergic skin responses in sensitized individuals over repeated contact
Carcinogenicity: Not listed by IARC, NTP, or OSHA as a cancer hazard
Reproductive Effects: Rare reproductive or developmental risks reported in animal models at high doses
Aquatic Toxicity: Toxic to aquatic life at high concentrations due to low degradability and uptake by microorganisms
Persistence and Degradability: Does not degrade easily in water or soil, bioaccumulates only weakly
Mobility in Soil: Moderately mobile, may spread through surface or groundwater in certain environmental conditions
Bioaccumulation: Low to moderate risk with continuous environmental exposure, persistent residue in wastewater
Other Adverse Effects: Avoid direct release into environment or municipal drains, not suitable for general wastewater disposal due to pharmaceutical nature
Safe Disposal Methods: Collect unused or spilled material, label as pharmaceutical waste, and transfer to licensed hazardous chemical disposal facility
Container Cleaning: Rinse empty packaging with plenty of water before discarding, minimize risk of residue release
Environmental Precautions: Do not allow the material or rinse water to contaminate natural water systems
Handling of Waste: Follow all local, state, and national regulations for API disposal, consult environmental health authority if unsure
Deactivation: Destroy active ingredient under supervision, avoid use of drain or standard landfill
UN Number: Not classified as a dangerous good for land, sea, or air transport
Shipping Name: Pravastatin Sodium, not otherwise specified
Transport Hazard Class: Non-hazardous for transport
Packing Group: Not applicable
Environmental Hazards: Avoid transporting with foodstuffs or animal feed; package to prevent accidental release in transit
Special Precautions for Transport: Ship in moisture-resistant secondary packaging, use clearly labeled transport containers
Inventory Status: Listed or exempt under most national chemical and pharmaceutical inventories
Labelling: Requires clear pharmaceutical labeling, use statements regarding restricted access and personnel safety requirements
Workplace Controls: Use substance in accordance with occupational health and exposure monitoring protocols
Sara Title III: Not listed as a hazardous substance or extremely hazardous under US regulations
OSHA Status: Not regulated as a specific workplace chemical, but prudent practices for hazardous drugs apply
Other Regulations: Compliance with Drug Enforcement Agency, environmental, and pharmaceutical import/export rules required during handling and distribution
