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Product Name: Rosuvastatin Calcium
Chemical Name: (E)-7-{4-(4-Fluorophenyl)-6-isopropyl-2-[methyl(methylsulfonyl)amino]pyrimidin-5-yl}(3R,5S)-3,5-dihydroxyhept-6-enoic acid calcium salt
CAS Number: 147098-20-2
Synonyms: Crestor, Zuvamor, Rosulip, Ridutril
Recommended Use: Pharmaceutical active ingredient in lipid-regulating medications
Manufacturer Contact Information: Found on packaging or safety documentation supplied with procurement
Emergency Number: Refer to local poison control or site-specific emergency center
Classification: Not classified as hazardous according to GHS criteria for solid pharmaceutical products; more detailed hazard risk for dust or fine particles
Potential Health Effects: May cause respiratory irritation, mild skin or eye irritation, harmful if large quantities are ingested
Signal Word: Warning
Hazard Statements: May cause an allergic skin reaction, suspected of damaging fertility or the unborn child
Precautionary Statements: Avoid breathing dust, wear appropriate PPE for handling, wash exposed skin thoroughly
Pictograms: Exclamation mark as minimal hazard
Chemical Identity: Rosuvastatin Calcium
Purity: >98% (typical for pharmaceutical use)
Formula: C22H27FN3O6S2 . Ca
Molecular Weight: 1001.14 g/mol (calculated as the calcium salt)
Impurities: Below safety threshold for specifications; consult Certificate of Analysis for batch detail
Other Ingredients: None (active ingredient form)
Inhalation: Move individual to fresh air, monitor for breathing difficulties, seek medical advice if symptoms persist
Skin Contact: Wash with mild soap and water, remove contaminated clothing, consult medical support if irritation occurs
Eye Contact: Rinse cautiously with water for several minutes, remove contact lenses if present, continue rinsing; obtain medical evaluation if irritation remains
Ingestion: Rinse mouth, do not induce vomiting, seek medical attention promptly, show this sheet to health professional
Most Important Symptoms: Mild respiratory, skin, or eye irritation; gastrointestinal upset if ingested in significant amounts
Extinguishing Media: Use dry chemical, CO2, foam, or water spray
Special Hazards: Fine dust, if airborne, can form explosive mixtures in air under rare circumstances
Hazardous Decomposition Products: May emit hazardous fumes like carbon oxides, sulfur oxides, nitrogen oxides, hydrogen fluoride under fire conditions
Protective Equipment: Firefighters should use full protective gear and self-contained breathing apparatus
Advice for Firefighters: Avoid inhaling combustion products, control runoff
Personal Precautions: Evacuate unnecessary personnel, use personal protective equipment to prevent contact with skin, eyes, and clothing
Environmental Precautions: Avoid release to water systems, use containment methods to limit spread
Spill Cleanup Methods: Carefully sweep up or vacuum without producing dust, place in a secure container for disposal, clean area with water and detergent
Disposal: Dispose according to local environmental regulations
Handling: Minimize dust generation, process in closed systems where possible, avoid contact with skin and eyes, wear suitable gloves, lab coats, and safety goggles, wash hands after handling
Storage: Store tightly sealed in a dry, cool, well-ventilated place, keep away from incompatible materials such as strong oxidizers or acids, protect from light and moisture, secure from unauthorized access
Special Requirements: Follow all national and local storage rules for pharmaceutical actives
Exposure Limits: Specific occupational exposure limits not established, use pharmaceutical handling limits as recommended by industrial hygiene protocols
Engineering Controls: Handle in fume hood or ventilated enclosure, use HEPA filtration if dust generation is likely
Personal Protection: Use gloves made of nitrile or similar resistant materials, chemical splash goggles, lab coats or coveralls, and if dust exposure is possible, an approved particulate respirator
Hygiene Measures: Do not eat, drink, or smoke while handling; wash thoroughly after use
Appearance: White to off-white powder
Odor: Odorless
pH: No data for solid; slightly acidic in solution
Solubility: Slightly soluble in water, more soluble in DMSO and methanol
Melting Point: 120-140°C (decomposition may occur)
Boiling Point: Data not available
Density: Not determined
Partition Coefficient: LogP approximately 0.1
Vapor Pressure: Negligible
Flash Point: Not applicable (non-volatile solid)
Chemical Stability: Stable under recommended conditions, keep away from extremes of humidity or temperature
Conditions to Avoid: Strong heat, moisture, direct sunlight
Materials to Avoid: Strong oxidizers, acids
Hazardous Decomposition: Thermal decomposition releases toxic fumes such as carbon monoxide, sulfur oxides, fluorine compounds
Hazardous Polymerization: Does not occur
Acute Toxicity: Low toxicity via oral, inhalation, or dermal exposure in animal studies
Potential Effects: Overexposure may cause headache, nausea, dizziness; high doses linked to liver or muscle injury in susceptible people
Skin Corrosivity/Irritation: Not a skin corrosive; mild irritant
Eye Effects: Mild irritant
Sensitization: May cause mild allergic reactions in sensitive individuals
Chronic Effects: Prolonged exposure to high concentrations may affect liver or kidney function
Carcinogenicity: No evidence for carcinogenicity in animal tests
Mutagenicity: Not mutagenic in standard laboratory studies
Reproductive Toxicity: Possible risk based on mechanism of action; consult safety guidelines for pregnant or breastfeeding employees
Ecotoxicity: Considered low risk to aquatic environments in typical pharmaceutical usage, yet not suitable for uncontrolled disposal
Mobility: Low mobility in soil when in solid form
Persistence and Degradability: Not rapidly biodegradable; slow photolysis in the environment
Bioaccumulation Potential: Moderate potential in aquatic species
Aquatic Toxicity: Available data suggest moderate toxicity for algae and daphnia at high concentrations
Additional Information: Avoid release to natural waters, sewage systems, or soils, best practice involves contained disposal
Waste Treatment Methods: Take unused or waste material to a licensed hazardous waste contractor
Container Disposal: Triple rinse containers, then follow site protocol for hazardous packaging
Do Not: Dispose in household waste, sinks, or regular trash
Regulatory Disposal Guidance: Follow regional and national regulations for pharmaceutical waste, such as RCRA in the US or relevant international frameworks
UN Number: Not assigned for non-bulk shipments
UN Proper Shipping Name: Not regulated for transport
Transport Hazard Class: Not classified as a transport hazard
Packing Group: Not applicable
Special Precautions: Pack securely to avoid generating airborne dust, ship in sealed containers
Marine Pollutant: Not designated as marine pollutant
Additional Information: Check local shipping rules for pharmaceutical actives, document with shipping paperwork
Safety, Health, and Environmental Regulations: Listed as a prescription pharmaceutical active; monitored under workplace safety laws for hazardous substances
Risk Phrases: R36/37/38: Irritating to eyes, respiratory system and skin
Regulatory Status: Included on pharmaceutical regulatory lists in most countries
OSHA Classification: Not classified as hazardous for solid-tablet or encapsulated forms
WHMIS Status (Canada): Not controlled in finished dosage form; controlled as an API
Additional Information: Handle according to specific institutional, national, and international regulations for pharmacological substances
