Product Name: (S)-Alpha,Alpha-Diphenyl-3-Pyrrolidineacetamide-L-tartrate Darifenacin
Other Names: Darifenacin Hydrobromide, ENABLEX
Recommended Use: Pharmaceutical active ingredient, research chemical
Manufacturer Information: Provide physical address, phone number, and emergency contact
Emergency Phone Number: National and local poison control centers, company emergency hotline
Product Code/Identifier: CAS Number: 133099-07-7
Relevant Identified Uses: Urinary antispasmodic for overactive bladder treatment
Restrictions: For laboratory and pharmaceutical use, not for general household use
GHS Classification: Not classified as hazardous under GHS for most guidelines, but consult country-specific regulations
Signal Word: Warning
Hazard Statements: May cause irritation to eyes, skin, and respiratory tract. Potential central nervous system effects. Risk of reproductive toxicity cannot be ruled out.
Precautionary Statements: Avoid inhalation, wear suitable gloves and eye protection, wash thoroughly after handling, do not eat, drink, or smoke when using material
Pictograms: Exclamation mark, Health hazard symbol
Other Hazards: Environmental hazard not fully assessed, possible risk of dust explosion in finely divided form
Chemical Name: (S)-Alpha,Alpha-Diphenyl-3-Pyrrolidineacetamide-L-tartrate
Synonyms: Darifenacin, ENABLEX
CAS Number: 133099-07-7
EC Number: Not assigned
Impurities/Additives: May include trace residual solvents or process chemicals based on manufacturing method
Concentration: Active ingredient (typically 98%+ purity)
Molecular Formula: C28H30N2O6
Molecular Weight: 490.55 g/mol
Inhalation: Move person outdoors, seek medical attention if symptoms like shortness of breath, dizziness, or coughing develop
Skin Contact: Wash skin with soap and water for at least 15 minutes, remove contaminated clothing, seek medical advice if irritation persists
Eye Contact: Rinse eyes with plenty of water for 15 minutes, lift eyelids occasionally, obtain medical attention
Ingestion: Rinse mouth, do not induce vomiting unless instructed by medical personnel, seek medical help
Acute Symptoms: Nausea, dizziness, headache, dry mouth, possible blurred vision or increased heart rate
Medical Advice: Health care providers should monitor for signs of anticholinergic toxicity, symptomatic treatment as required
Suitable Extinguishing Media: Carbon dioxide, dry chemical powder, foam, water spray
Unsuitable Media: High-pressure water jets may spread dust
Special Hazards: Combustion can produce toxic fumes, including nitrogen oxides, carbon oxides
Protective Equipment: Use self-contained breathing apparatus and full protective suit
Firefighting Procedures: Avoid inhalation of smoke, keep containers cool with water spray, isolate area if possible
Personal Precautions: Evacuate non-essential personnel, use personal protective equipment such as gloves, goggles, and dust mask
Environmental Precautions: Prevent entry into drains, soil, and waterways
Methods for Containment: Dampen with water to avoid dusting, collect material using non-sparking tools
Methods for Cleanup: Pick up and transfer to sealed, labeled waste containers for disposal according to regulations, wash area with detergent and water after removal
Handling: Use in ventilated area, avoid breathing dust, avoid skin and eye contact, wash hands before breaks and after handling
Storage Conditions: Store in cool, dry, well-ventilated place, keep container tightly closed
Incompatible Materials: Oxidizing agents, strong acids and bases
Other Precautions: Keep away from food, beverages, and animal feed, avoid all unnecessary exposure
Occupational Exposure Limits: No specific OEL for Darifenacin, follow general dust exposure recommendations (ACGIH TLV for nuisance dust: 10 mg/m³ total dust, 3 mg/m³ respirable)
Engineering Controls: Mechanical exhaust required, fume hood recommended for laboratory use
Personal Protection: Chemical-resistant gloves, safety goggles, lab coat, approved dust mask or respirator if dust may be generated
Hygiene Measures: Do not eat, drink, or smoke during use, wash hands thoroughly after handling, remove contaminated clothing and wash before reuse
Appearance: White or off-white crystalline powder
Odor: Odorless or faint chemical smell
Odor Threshold: Not available
pH: Not determined (aqueous solutions are slightly acidic)
Melting Point: 216–223°C
Boiling Point: Decomposes before boiling
Flash Point: Not applicable
Evaporation Rate: Not determined
Flammability: Material can burn, no explosive hazards recorded
Vapor Pressure: Not available
Relative Density: About 1.3 g/cm³
Solubility: Slightly soluble in water, soluble in ethanol and organic solvents
Partition Coefficient (log Kow): 3.4
Auto-ignition Temperature: Not determined
Decomposition Temperature: Decomposes on heating
Viscosity: Not applicable
Chemical Stability: Stable under recommended storage conditions
Possible Reactions: No dangerous reactions known under normal use
Conditions to Avoid: High humidity, heat, sparks, open flame, and other ignition sources
Incompatible Materials: Strong oxidizing agents, strong acids and bases
Hazardous Decomposition: Carbon dioxide, carbon monoxide, nitrogen oxides, other unidentified organic compounds formed on burning or thermal decomposition
Routes of Exposure: Inhalation, ingestion, skin absorption, eye contact
Acute Toxicity: Oral LD50 (rat): >2000 mg/kg (available animal data)
Skin Corrosivity/Irritation: May cause mild irritation
Eye Damage/Irritation: May cause mild irritation
Sensitization: Not reported as sensitizing in animal or human studies
Chronic Toxicity: Animal studies show effects on liver and nervous system at high doses; long-term health effects in humans not fully assessed
Carcinogenicity/Mutagenicity: Not classified as carcinogen or mutagen by major agencies
Reproductive Toxicity: Potential risk based on animal data at high doses
Symptoms of Exposure: Dry mouth, blurred vision, difficulty urinating, constipation, headache, confusion, rapid heartbeat at high exposures
Aquatic Toxicity: No comprehensive data, but potential toxic effect on aquatic organisms cannot be excluded
Persistence and Degradability: Likely to undergo slow degradation in environment
Bioaccumulative Potential: Moderate potential due to log Kow above 3
Mobility in Soil: May be partly mobile, risk of contamination to groundwater possible in bulk spills
Other Adverse Effects: No large-scale environmental incidents reported, but care required to prevent environmental release
Waste Disposal Methods: Collect and dispose of chemical waste according to local, national, and international regulations for pharmaceutical waste
Disposal of Contaminated Packaging: Triple rinse containers, puncture and dispose of by incineration or authorized landfill
Other Recommendations: Do not discharge to sewer systems or natural water bodies, consult hazardous waste specialist for bulk quantities
UN Number: Not regulated as hazardous for transport
Proper Shipping Name: Chemical, not otherwise specified
Transport Hazard Class: Non-hazardous
Packing Group: Not classified
Special Precautions: Protect from physical damage, keep container tightly closed during transport
Environmental Hazards: Not classified as marine pollutant
Transport Labels: None required by most regulations
International Guidelines: Subject to regional pharmaceutical and chemical regulations (such as EU REACH, US TSCA exemption for drugs)
OSHA: Complies with Hazard Communication Standard, not listed specifically as hazardous
EPA: Not listed under CERCLA, SARA, or RCRA
WHMIS (Canada): Not controlled under WHMIS
Other Regional Registration: Meets ICH guidelines for pharmaceutical substances
Inventory Listings: Not listed separately as an industrial chemical due to pharmaceutical use
Labeling Requirements: Hazard warnings, precautionary statement, product identification, name and address of supplier on original container
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