MSDS for Varenicline Tartrate Intermediates

Identification

Product Name: Varenicline Tartrate Intermediate
Chemical Family: Alkaloid derivative
Synonym: Partial nicotinic acetylcholine receptor agonist intermediate
Manufacturer: Identified through supply chain documentation only
Contact Information: Emergency response and manufacturer’s details available on request
Recommended Use: Pharmaceutical synthesis
Restrictions on Use: Not for food, cosmetic, or household applications; industrial or research use only

Hazard Identification

Classification: Eye irritant, Skin sensitizer, Harmful if swallowed
Label Elements: Warning symbol (exclamation mark), hazard statements for irritation and ingestion risk
Signal Word: Warning
Hazard Statements: Causes skin and eye irritation, may cause respiratory irritation, harmful if swallowed
Precautionary Statements: Avoid breathing dust, wear eye and skin protection, wash exposed skin after handling, use in a ventilated area
Other Hazards: May release toxic or irritating fumes upon combustion, toxic to aquatic life with long-term effects

Composition / Information on Ingredients

Chemical Identity: Proprietary intermediates of varenicline tartrate
CAS Number: Assigned based on specific intermediate; company catalog numbers used in inventory tracking
Concentration: ≥ 95% active pharmaceutical intermediate; impurities typically less than 2%
Impurities: Sourced from controlled synthesis; residual solvents and by-products present at trace levels
Additives: None reported; single-component organic intermediate

First Aid Measures

Inhalation: Move exposed individuals to fresh air, offer respiratory support if breathing is impaired, seek medical advice if symptoms linger
Skin Contact: Remove contaminated clothing, wash exposed skin with soapy water, maintain medical supervision for persistent irritation
Eye Contact: Flush eyes with plenty of water for a minimum of 15 minutes, avoid rubbing, seek medical attention if pain or redness persists
Ingestion: Rinse mouth, avoid inducing vomiting, ensure individual is conscious, and transport to medical facility
Symptoms: Respiratory discomfort, skin redness, burning eye sensation, gastrointestinal upset if ingested

Fire-Fighting Measures

Suitable Extinguishing Media: Dry chemical, CO2, foam, or water spray for surrounding fire
Unsuitable Extinguishing Media: Avoid high-pressure water jets which may spread chemical dust
Specific Hazards: Combustion products may include nitrogen oxides, carbon monoxide, carbon dioxide, and toxic organic vapors
Protective Equipment: Firefighters should wear full protective suit and self-contained breathing apparatus
Other Information: Evacuate area, prevent runoff from entering waterways, cool exposed containers with water spray

Accidental Release Measures

Personal Precautions: Use personal protective equipment such as gloves and eye protection, avoid inhalation of dust, restrict unprotected personnel from spill area
Environmental Precautions: Prevent chemicals from entering drains, sewers, or surface water
Cleanup Methods: Scoop up solid without generating dust, place in suitable waste container, ventilate and clean contaminated area with water
Disposal: Collected waste handled as hazardous material, adhere to local and national disposal guidelines

Handling and Storage

Handling: Use in a chemical fume hood, wear gloves and eye protection, avoid breathing dust or contact with skin, wash hands after handling
Storage Conditions: Store in tightly closed containers; keep in a cool, dry, well-ventilated area, away from strong oxidizing agents
Incompatibilities: Avoid storage with acids, bases, or oxidizing substances
Special Requirements: Access restricted to trained personnel, standard laboratory hygiene protocols in effect

Exposure Controls and Personal Protection

Engineering Controls: Local exhaust ventilation or certified chemical fume hood
Personal Protective Equipment: Chemical-resistant gloves, splash safety goggles, lab coat, optional face shield for extended exposure
Respiratory Protection: NIOSH-approved dust mask or respirator for airborne particles
Hygiene Measures: Do not eat, drink, or smoke during use; wash hands before breaks and after handling
Environmental Controls: Prevent release to the environment, use spill controls to limit area of exposure

Physical and Chemical Properties

Appearance: Off-white to light brown powder or crystalline solid
Odor: Mild chemical odor
Odor Threshold: Not established
pH: Not applicable for solids
Melting Point/Freezing Point: Melting range 110–175°C depending on specific intermediate
Boiling Point: Decomposes before boiling
Flash Point: Not easily combustible
Evaporation Rate: Not applicable
Flammability: Low combustible risk, generates toxic smoke if burned
Vapor Pressure: Negligible
Solubility: Slightly soluble in water, soluble in methanol and DMSO
Partition Coefficient (n-octanol/water): Not available
Auto-ignition Temperature: Not determined
Decomposition Temperature: Above 180°C with breakdown to hazardous gases

Stability and Reactivity

Chemical Stability: Stable under recommended storage conditions
Possibility of Hazardous Reactions: None under normal processing; strong oxidizing agents may trigger dangerous decomposition
Conditions to Avoid: Avoid excessive heat, moisture, and incompatible materials
Incompatible Materials: Strong acids, strong bases, oxidizers
Hazardous Decomposition Products: Carbon oxides, nitrogen oxides, and other toxic vapors produced when decomposed by heat or fire

Toxicological Information

Acute Toxicity: Oral and dermal toxicity present; specific LD50 values under review
Potential Health Effects: Irritation to skin and eyes, respiratory tract discomfort, gastrointestinal upset, possible CNS effects after significant exposure
Skin Corrosion/Irritation: Demonstrated in animal studies; proper PPE needed
Eye Damage/Irritation: Redness, tearing, stinging sensation
Carcinogenicity: Not listed by NTP, IARC, or OSHA
Mutagenicity: No mutagenic activity reported in standard assays
Reproductive Toxicity: Data unavailable, handle with all usual precautions for research chemicals
Sensitization: May cause allergic reactions in susceptible individuals

Ecological Information

Ecotoxicity: Harmful to aquatic organisms; laboratory testing indicates risk for bioaccumulation
Persistence and Degradability: Organic intermediate degrades slowly under environmental conditions
Bioaccumulative Potential: Moderate; monitor effluent and avoid release to surface water
Mobility in Soil: Low mobility due to organic structure; partitions strongly to solids
Other Adverse Effects: No data on specific ozone or endocrine disruption

Disposal Considerations

Waste Disposal Methods: Dispose as hazardous waste following national and local regulations, chemical incineration advised if available
Contaminated Packaging: Rinse containers before disposal, triple-rinse for chemical safety, then treat as hazardous waste
Other Precautions: Prevent disposal to drains, soil, or natural water sources, retain waste transfer documentation

Transport Information

UN Number: Not assigned except for large commercial shipments
UN Proper Shipping Name: Organic solid, n.o.s. (not otherwise specified), including varenicline intermediates
Transport Hazard Class: Not classified as hazardous by ground, air, or sea under most national regulations
Packing Group: Usually Packing Group III for mild irritants
Special Precautions: Avoid shipping with incompatible chemicals or foodstuffs
Environmental Hazards: Do not transport with bulk aquatic toxic substances
Transport in Bulk: Not regulated for bulk shipping

Regulatory Information

US Federal: Not listed as a controlled substance, but subject to chemical inventory rules and OSHA workplace safety standards
TSCA Status: Listed if relevant significant new use rules apply for research chemicals
EU Regulations: Registered under REACH if production threshold is met, classified under CLP as hazardous
Other Global: Must comply with Japan Chemical Substances Control Law and Canada DSL/NDSL depending on manufacturer location
Labeling Requirements: Hazard statements, pictograms, and manufacturer's contact information required on all workplace containers
Product Registrations: Local regulations may require notification of use, inventory annual reporting, and environmental release controls