Product Name: Varenicline Tartrate
Chemical Formula: C13H13N3•C4H6O6
Synonyms: Champix, Chantix
Manufacturer: Listed on pharmaceutical packaging
Recommended Use: Smoking cessation
Contact Information: Available on product label
CAS Number: 375815-87-5
Emergency Telephone: Refer to local poison control center or regional chemical safety agency
Product Code: Provided by supplier
Relevant Identified Uses: Prescription medication for nicotine addiction
Restrictions on Use: Only for use as directed by health professionals
Classification: Toxic if swallowed; irritant to eyes, respiratory system, and skin
GHS Labelling: Skull and crossbones symbol, exclamation mark
Signal Word: Danger
Hazard Statements: May cause organ damage through prolonged or repeated exposure; may cause harmful effects on the nervous system; irritating to mucous membranes
Precautionary Statements: Avoid contact with eyes, skin, and clothing; wash thoroughly after handling; avoid breathing dust or vapors; use only with adequate ventilation; keep container tightly closed
Potential Health Effects: Headache, nausea, vomiting, psychiatric disturbances, allergic skin reactions
Routes of Exposure: Inhalation, ingestion, skin or eye contact
Target Organs: Central nervous system, liver, kidneys
Environmental Hazards: Harmful to aquatic life with long-lasting effects
Substance: Varenicline Tartrate
Chemical Name: 7,8,9,10-Tetrahydro-6,10-methano-6H-pyrazino[2,3-h][3]benzazepine tartrate
CAS Number: 375815-87-5
Concentration: Greater than 95% (pharmaceutical grade)
Impurities: Trace process-derived impurities, pharmaceutical excipients as inactive ingredients
Molecular Weight: 361.4 g/mol
General Advice: Seek immediate medical attention for all exposures
Inhalation: Move person to fresh air; keep warm and at rest; provide artificial respiration or oxygen if breathing is difficult
Skin Contact: Remove contaminated clothing; wash affected area with soap and water; consult a physician if irritation persists
Eye Contact: Rinse cautiously with water for at least 15 minutes; remove contact lenses if present and easy to do; obtain medical attention
Ingestion: Rinse mouth; do not induce vomiting, unless directed by medical personnel; give water to drink if conscious; contact poison control center or physician
Symptoms and Effects: May include nausea, confusion, abdominal pain, psychiatric changes, hepatic or renal symptoms
Suitable Extinguishing Media: Water spray, alcohol-resistant foam, dry chemical, carbon dioxide
Unsuitable Extinguishing Media: High pressure water jet
Specific Hazards: Emits toxic fumes under fire conditions (carbon oxides, nitrogen oxides)
Protective Equipment: Self-contained breathing apparatus and full protective gear
Special Precautions: Avoid inhaling dust, smoke, or fumes; prevent runoff from entering drains or watercourses
Hazard Combustion Products: Carbon monoxide, carbon dioxide, nitrogen oxides, other hazardous gases
Personal Precautions: Use personal protective equipment; avoid breathing dust; ensure adequate ventilation; evacuate unnecessary personnel from area
Environmental Precautions: Prevent further leakage or spillage if safe to do so; do not allow product to reach drains, surface water, or ground water
Methods for Clean-Up: Collect spilled material using inert absorbent (e.g., sand); sweep up and place in suitable labeled containers for disposal according to local regulations; ventilate area and wash spill site after material pick-up
Emergency Procedures: Follow facility emergency response plans; notify authorities if significant release occurs
Handling: Avoid contact with skin, eyes, and clothing; use with adequate exhaust ventilation; wash hands thoroughly after handling; do not eat, drink, or smoke while handling
Storage Conditions: Store in original container, tightly closed, in a cool, dry, and well-ventilated area; protect from light, moisture, and incompatible materials
Incompatible Materials: Strong oxidizers, acids, bases
Specific Uses: Use only as directed for pharmaceutical preparation
Safety Precautions: Keep away from food, drink, and animal feeding stuffs; store away from unauthorized personnel
Control Parameters: Occupational exposure limits not established for this compound
Engineering Controls: Use local exhaust ventilation or other engineering controls to keep airborne levels below recommended exposure limits
Personal Protective Equipment (PPE): Safety glasses with side shields, gloves made of nitrile or other chemical-resistant material, lab coat or protective clothing
Respiratory Protection: Use suitable respiratory equipment if ventilation is inadequate
Hygiene Measures: Wash hands, forearms, and face thoroughly after handling; remove contaminated clothing and wash before reuse
Thermal Hazards: Avoid excessive heat during handling
Appearance: White to off-white crystalline powder
Odor: Odorless
Odor Threshold: Not determined
pH Value: Not applicable (neutral in solid form)
Melting Point/Freezing Point: 225–230°C (decomposition starts above this range)
Boiling Point: Data not available
Flash Point: Not relevant
Evaporation Rate: Not applicable
Upper/Lower Flammability Limits: No data
Vapor Pressure: Negligible at ambient temperature
Vapor Density: Not applicable
Relative Density: Approximately 1.5–1.7 g/cm³
Solubility: Soluble in water and methanol, slightly soluble in ethanol
Partition Coefficient (n-octanol/water): Not determined
Auto-ignition Temperature: No data
Decomposition Temperature: Above 225°C
Viscosity: Not applicable
Chemical Stability: Stable under recommended storage conditions
Reactivity: No dangerous reactions known under normal conditions
Conditions to Avoid: Exposure to excessive heat, moisture, and light
Materials to Avoid: Strong oxidizing agents, strong acids and bases
Hazardous Decomposition Products: Carbon monoxide, carbon dioxide, nitrogen oxides upon combustion or thermal decomposition
Polymerization: No risk of hazardous polymerization under normal handling
Acute Toxicity: Oral, rat LD50: 23 mg/kg (Varenicline base)
Inhalation: Dust may cause respiratory tract irritation
Dermal: Not expected to be significantly absorbed through skin
Skin Corrosion/Irritation: May cause mild irritation to skin
Serious Eye Damage/Irritation: Likely irritation and redness
Respiratory/Skin Sensitization: Could cause allergic reactions after repeated exposure
Specific Target Organ Toxicity: Risk of neuropsychiatric symptoms, liver and kidney effects, cardiac events in predisposed individuals
Mutagenicity: No evidence from standard studies at therapeutic doses
Carcinogenicity: No known human carcinogenicity, animal studies did not show tumor formation
Reproductive Toxicity: Not proven in humans, animal studies revealed some adverse fetal effects at high doses
Long-Term Effects: Psychiatric changes (mood, behavior), headache, gastrointestinal discomfort
Ecotoxicity: Harmful to aquatic life with long-term effects; risk of bioaccumulation in water systems
Persistence and Degradability: Not readily biodegradable; pharmaceutical substances tend to persist in environment
Bioaccumulative Potential: Potential exists based on chemical properties
Mobility in Soil: May migrate through soil and reach groundwater
Other Adverse Effects: Ongoing pharmaceutical contamination linked with behavioral changes in aquatic organisms, avoid release to environment
Waste Treatment Methods: Collect for disposal in accordance with local, regional, national, international laws; recommended incineration by licensed waste disposal contractor
Product Disposal: Do not dispose of as household waste; return unused or expired medication to take-back programs or hazardous waste facilities
Contaminated Packaging: Rinse and dispose as chemical waste or return to supplier if possible
Special Precautions: Avoid contamination of sewers, waterways, and soil; consult regulations for proper handling of pharmaceutical waste
UN Number: Not classified as hazardous for transport in standard amounts
UN Proper Shipping Name: Not regulated
Transport Hazard Class(es): None
Packing Group: None assigned for therapeutic doses
Environmental Hazards: Avoid uncontrolled releases; not a marine pollutant
Special Precautions for User: Use secure packaging, prevent accidental breakage, keep away from food and feed
Safety, Health, and Environmental Regulations: Substance regulated by national pharmaceutical and health agencies (FDA, EMA, etc.); OSHA Hazard Communication Standard requires handling as hazardous substance
International Inventories: Not listed on most chemical substance inventories due to pharmaceutical status
Regulations: Controlled by prescription and pharmaceutical guidelines; not regulated as a transport hazard but recognized as a hazardous substance under workplace regulations
Other Requirements: Safety training for handling; compliance with occupational exposure limits; environmental release reporting in event of major spill
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