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Product Name: Clopidogrel Bisulfate Type 1
Chemical Name: Methyl (+)-(S)-α-(2-chlorophenyl)-6,7-dihydrothieno[3,2-c]pyridine-5(4H)-acetate sulfate
Synonyms: Clopidogrel Hydrogen Sulfate
CAS Number: 120202-66-6
Manufacturer: Major pharmaceutical supplier
Recommended Use: Antiplatelet agent for prevention of vascular events
Emergency Number: Refer to national poison control center or regulatory contact
GHS Classification: Not classified as hazardous according to GHS for bulk substance
Signal Word: None
Hazard Statement: Inhalation, ingestion, or contact with skin or eyes can cause irritation or allergic reaction in sensitized individuals; risk of blood-related adverse effects on accidental exposure
Precautionary Statement: Handle with care, avoid breathing dust or fumes, prevent contact with eyes or skin, wash hands thoroughly after use
Potential Health Effects: May affect blood clotting, exposure can lead to risk of bruising or bleeding, repeated exposure over longer periods may cause organ damage
Signs and Symptoms: Eye, skin, or respiratory tract irritation, unusual bleeding, rash, allergic response
Environmental Hazards: No acute aquatic hazard identified, but avoid release to environment
Chemical Identity: Clopidogrel Bisulfate
Purity: Typically >98%
Impurities: Trace synthetic impurities below controlled regulatory thresholds
Main Hazardous Components: None at hazardous quantities in pharmaceutical form; in manufacturing, presence of active and process residues must be respected
Other Ingredients: No significant excipients or additives in pure material; finished dosage forms may contain mannitol, cellulose, and magnesium stearate as inert fillers or binding agents
Inhalation: Move affected person to fresh air, monitor for respiratory distress, seek immediate medical attention if symptoms persist
Eye Contact: Rinse cautiously with water for several minutes, remove contact lenses if present and easy to do, obtain medical advice if irritation develops
Skin Contact: Wash exposed skin with plenty of water and soap, remove contaminated clothing, seek attention for persistent irritation or allergic reaction
Ingestion: Rinse mouth with water, do not induce vomiting, seek prompt medical evaluation, provide information on amount and time of exposure
Medical Advice: Treat symptomatically with special attention to possible blood coagulation disturbances
Suitable Extinguishing Media: Water spray, foam, dry chemical, or carbon dioxide; select agent suitable for surroundings
Unsuitable Media: Avoid strong water jets to prevent dust spread
Specific Hazards: Product may emit toxic fumes—including nitrogen oxides, sulfur oxides, and hydrochloric acid—at high temperature
Firefighter Protection: Use full protective gear including self-contained breathing apparatus
Thermal Decomposition: Fumes may include oxides of carbon, sulfur, nitrogen, and hydrochloric acid; maintain safe distance
Explosion Hazard: Not sensitive to static or impact in supplied form
Personal Precautions: Use personal protective equipment including gloves, protective eyewear, dust mask or respirator, avoid dust generation
Environmental Precautions: Prevent spills from entering drains, waterways, or soil
Small Spill Cleanup: Collect spilled material with suitable tools wearing protective equipment, avoid dust formation, place in labeled container for disposal
Large Spill Handling: Isolate area, ventilate affected space, prevent dispersal of dust, use vacuum or wet sweeping if safe
Decontamination: Wash affected area with water and suitable detergent, dispose of cleaning materials as hazardous waste
Handling: Use only in well-ventilated area, avoid generation of dust, use local exhaust ventilation if available; avoid inhalation and direct contact; wear appropriate gloves and safety goggles
Hygiene Practices: Do not eat, drink, or smoke when using this product, wash hands after handling
Storage Conditions: Store in tightly closed original container in a cool, dry, and well-ventilated area, away from incompatible materials; protect from moisture and direct sunlight
Shelf Life: Refer to supplier specifications for maximum recommended storage duration
Incompatibles: Strong oxidizing agents, acidic or basic environments may degrade product
Occupational Exposure Limits: No established OSHA PEL or ACGIH TLV for this compound; minimize occupational exposure as low as reasonably achievable
Engineering Controls: Use appropriate engineered controls such as local exhaust ventilation or containment
Personal Protective Equipment: Chemical-resistant gloves, protective safety goggles, lab coat or gown, dust mask or appropriate respirator for airborne particles
Special Handling: Use closed system transfers or containment during large-scale or repeated exposure
Hygiene: Remove contaminated clothing and wash before reuse; ensure facilities for eye and skin rinsing available
Appearance: White to off-white crystalline powder
Odor: Odorless
Odor Threshold: Not applicable
pH: Slightly acidic in solution
Melting Point/Freezing Point: 170°C–180°C (decomposition)
Boiling Point: Not determined due to decomposition
Flash Point: Not data available
Evaporation Rate: Not relevant (solid)
Flammability: Not classified as flammable
Upper/Lower Flammability or Explosive Limits: Not determined
Vapor Pressure: Negligible at room temperature
Vapor Density: Not applicable
Relative Density: 1.3–1.5 g/cm³ (approx.)
Solubility: Freely soluble in methanol, slightly soluble in water
Partition Coefficient (n-octanol/water): 3.9 (estimated)
Auto-ignition Temperature: Not determined
Decomposition Temperature: >170°C
Viscosity: Not applicable (powder)
Chemical Stability: Stable under recommended handling, transportation and storage conditions
Reactivity: Does not undergo hazardous reactions under normal use
Incompatible Materials: Strong oxidizers, strong acids, alkali, moisture may decrease stability
Hazardous Decomposition: Under fire conditions decomposes to toxic gases including NOx, SOx, HCl
Polymerization: Does not occur
Conditions to Avoid: Excess heat, open flames, humidity, direct sunlight
Routes of Exposure: Inhalation, skin and eye contact, ingestion
Acute Toxicity: Oral LD50 in rats estimated >2000 mg/kg; significant effects only at high doses
Chronic Toxicity: Repeated dosing can produce changes in blood chemistry including risk of bleeding; evidence from animal studies shows risk of liver and kidney changes at high doses
Carcinogenicity: Not classified as carcinogen
Sensitization: Rare reports of hypersensitivity in occupational settings
Mutagenicity: No current evidence of mutagenicity from standard in vitro and in vivo tests
Reproductive Effects: No significant teratogenicity observed in animal studies at therapeutic exposure ranges
Symptoms: Anemia, bruising, allergic rash, gastrointestinal discomfort
Ecotoxicity: Limited data available; expected low environmental toxicity in diluted state; active ingredient at high concentration may impact aquatic organisms
Persistence and Degradability: Product expected to be partially biodegradable under environmental conditions, not considered persistent in soil/water systems
Bioaccumulation: Low potential for bioaccumulation due to pharmacological breakdown
Mobility in Soil: Moderate mobility expected, substance may leach at high concentrations
Other Adverse Effects: Unlikely to cause long-term ecological harm following dilution and natural breakdown in environment
Waste Treatment Methods: Incineration at a licensed facility for pharmaceutical waste recommended; do not flush down drains
Disposal of Contaminated Packaging: Triple rinse, then manage as pharmaceutical waste in accordance with local regulations
Special Precautions: Avoid unprotected contact during disposal; utilize gloves and eyewear
Regulatory Status: Handle as hazardous chemical waste or medicine waste, in accordance with federal and local guidelines
UN Number: Not assigned
UN Proper Shipping Name: Not regulated as dangerous goods
Transport Hazard Class: Non-hazardous for ground, air, and sea shipment in original packaging; spills or bulk material may be subject to hazardous material codes locally
Packing Group: Not applicable
Environmental Hazards: Not a marine pollutant
Special Precautions for User: Store away from incompatible products, keep secure and labeled
OSHA Status: Not specifically listed as hazardous
TSCA Inventory: Not required for pharmaceutical substances
WHMIS Classification (Canada): Not controlled
EU Classification: Regulated as medicinal product; not classified as health hazard under CLP
SARA Title III: Not identified as extremely hazardous
REACH Status: Exempt as active pharmaceutical ingredient
Other Regulations: Must meet local, national, and international standards for drug substance transport, handling, and waste management
