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Product Name: Simvastatin Ammonium Salt
Chemical Synonyms: Simvastatin ammonium salt, (1S,3R,7S,8S,8aR)-8-{2-[(2R,4R)-4-hydroxy-6-oxooxan-2-yl]ethyl}-3,7-dimethyl-1,2,3,7,8,8a-hexahydronaphthalen-1-yl 2,2-dimethylbutanoate ammonium salt
CAS Number: 139319-89-6
Recommended Use: Laboratory reagent, pharmaceutical applications
Manufacturer Information: Supplier details and emergency contact supplied on request by laboratory or procurement records
Emergency Contact Number: Refer to local site safety protocol for up-to-date information
Classification: Non-flammable, non-explosive; considered hazardous by regulatory definitions
GHS Classification: Acute toxicity (oral, skin), Specific target organ toxicity on repeated exposure
Hazard Statements: May cause damage to organs through prolonged or repeated exposure; harmful if swallowed
Signal Word: Warning
Pictogram: Exclamation mark, health hazard symbol
Precautionary Statements: Avoid inhalation, ingestion, or skin contact; use personal protective equipment as required
Potential Health Effects: Can cause irritation to eyes, skin, and respiratory system; long-term exposure may impact liver, kidney, or muscle function
Environmental Hazards: Harmful to aquatic life with long lasting effects
Chemical Name: Simvastatin Ammonium Salt
Common Name/Synonyms: Simvastatin ammonium salt
CAS Number: 139319-89-6
Concentration: >98% (Typical laboratory purity)
Impurities / Additives: No significant hazardous impurities reported in standard laboratory-reagent grade
General Advice: Seek medical attention for any sign of adverse reaction or persistent discomfort
Inhalation: Remove the exposed person to fresh air; monitor for breathing difficulties; provide oxygen support if indicated
Skin Contact: Rinse skin thoroughly with mild soap and water; remove contaminated clothing to reduce exposure
Eye Contact: Rinse eyes cautiously with water for several minutes; contact eye specialist if irritation persists
Ingestion: Give water to rinse mouth; do not induce vomiting; contact poison center or medical service for guidance
Symptoms and Effects: Nausea, headache, dizziness, irritation of skin or mucous membranes
Protection for Responders: Gloves and eye protection recommended during first aid tasks
Suitable Extinguishing Media: Use water spray, alcohol-resistant foam, dry chemical, or carbon dioxide
Unsuitable Extinguishing Media: High-pressure water jets may cause spread of dust
Special Hazards Arising: Combustion may release toxic fumes including carbon monoxide, carbon dioxide, nitrogen oxides
Advice for Firefighters: Wear self-contained breathing apparatus and chemical-resistant clothing; cool exposed containers of material
Other Information: Move containers from area if safe; avoid inhalation of dust, smoke, or fumes
Personal Precautions: Use gloves, laboratory coat, and protective eyewear to reduce risk of skin or eye contact; avoid raising dust during cleanup
Environmental Precautions: Prevent further release into drains, watercourses, or soil; isolate spill site from environmental pathways
Methods for Cleanup: Scoop up spill using non-sparking tools and collect in an appropriate waste container; ensure good ventilation; dispose as chemical waste in accordance with regulations
Decontamination: Wash affected area with plentiful water and detergent; check local environmental controls
Precautions for Safe Handling: Work in chemical fume hood or ventilated area; avoid skin and eye contact; practice strict personal hygiene and wash hands after handling
Storage Requirements: Keep container tightly closed in a dry, cool, and well-ventilated place; separate from incompatible materials such as oxidizing agents
Special Handling Guidance: Use transfer devices to minimize dust formation; clearly label storage containers with identity and hazard information; restrict access to trained personnel
Storage Stability: Protect from light and moisture; ensure solid at storage temperature to avoid degradation
Occupational Exposure Limits: No occupational exposure limits assigned; monitor airborne concentrations in laboratory/production settings
Engineering Controls: Use fume hoods or local exhaust ventilation systems to control airborne exposure
Personal Protective Equipment: Chemical-resistant gloves (nitrile or similar), safety goggles with side protection, laboratory gown or coveralls
Respiratory Protection: NIOSH-approved dust respirator for large spills, open use, or potential airborne exposure
Environmental Exposure Controls: Avoid release to environment through proper procedure and waste management
Appearance: White to off-white powder or crystalline solid
Odor: No significant odor
Odor Threshold: Not determined
pH (1% solution): 4.0–6.0
Melting Point/Range: 120–140°C (approximate, may vary by batch and purity)
Boiling Point: Not applicable under atmospheric pressure; decomposes before boiling
Flash Point: Not readily flammable
Evaporation Rate: Not volatile
Flammability: Non-flammable solid
Vapor Pressure: Negligible at room temperature
Density: 1.2–1.3 g/cm³ (solid)
Solubility: Soluble in methanol, ethanol, slightly soluble in water, insoluble in non-polar solvents
Partition Coefficient (log Kow): Estimated 4.7 (simvastatin free form)
Autoignition Temperature: Not available
Decomposition Temperature: >170°C
Viscosity: Not applicable
Chemical Stability: Stable under recommended storage and handling conditions; sensitive to moisture and light
Reactivity: Low reactivity under normal laboratory conditions; avoid contact with strong oxidizing or reducing agents
Hazardous Decomposition Products: Carbon monoxide, carbon dioxide, nitrogen oxides, other toxic fumes upon combustion
Possibility of Hazardous Reactions: Not known to polymerize or explode; avoid incompatible chemicals
Conditions to Avoid: Exposure to excessive moisture, heat, flame, and light
Acute Toxicity: Harmful if swallowed; animal studies show oral LD50 (rat) in range of 500–2000 mg/kg (simvastatin base)
Chronic Effects: Prolonged exposure may impair liver and musculoskeletal function; risk of rhabdomyolysis with excessive dose or duration
Carcinogenicity: No evidence in standard animal studies; not classified as carcinogen by NTP, IARC, OSHA
Mutagenicity: Negative in bacterial and mammalian cell mutation assays
Reproductive Toxicity: High doses in animals caused reduced fetal weight and skeletal variations
Routes of Exposure: Ingestion, inhalation, skin contact, eye contact
Specific Target Organ Toxicity: Liver, kidneys, muscle tissues reported as target organs in repeated dose studies
Symptoms of Overexposure: Headache, muscle pain, weakness, gastrointestinal discomfort
Ecotoxicity: Harmful to aquatic organisms; causes long-term adverse effects in the aquatic environment
Persistence and Degradability: Expected to degrade slowly under environmental conditions; potential for bioaccumulation exists
Bioaccumulative Potential: High log Kow value suggests potential for bioconcentration in aquatic organisms
Mobility in Soil: Limited mobility; strong adsorption to organic matter in soils
Other Hazardous Effects: Potential unknown chronic effects on non-target species cannot be excluded; further testing information may be limited
Waste Treatment Methods: Dispose according to local, regional, national, or international regulations for hazardous pharmaceutical waste
General Disposal Guidance: Treat as hazardous material; avoid disposal into the environment, sewers, or normal waste streams
Incineration: Controlled high-temperature incineration preferred where permitted; chemical residues handled as per regulatory protocols
Packaging Disposal: Triple rinse and dispose of containers as chemical waste; do not re-use for other purposes
UN Number: Not assigned under the UN Model Regulations
Proper Shipping Name: Simvastatin Ammonium Salt
Transport Hazard Class: Not classified as hazardous for transport by road, air, or sea
Packing Group: Not applicable
Environmental Hazards: May present risk to surface and ground waters if accidental release occurs
Special Precautions: Protect package from damage or moisture during transport; follow internal safety procedures
Transport Labels: Not required by DOT, IATA, or IMDG for small laboratory quantities
US Federal Regulations: Not listed under CERCLA, SARA Title III, or TSCA; handled as a pharmaceutical raw material
California Proposition 65: Not listed
OSHA: Classified as hazardous under the OSHA Hazard Communication Standard
International Regulations: Not licensed as a controlled substance; subject to prescription drug and chemical safety laws in applicable regions
REACH/CLP (EU): Exempt as pharmaceutical active ingredient; topic subject to periodic review by ECHA
Other Relevant Regulations: Follow local workplace safety, environmental release, and chemical management guidelines
