Product Name: Tolterodine Tartrate
Synonyms: (−)-2-(Diisopropylamino)ethyl phenol tartrate
Chemical Formula: C22H31NO•C4H6O6
Molecular Weight: 475.6 g/mol
Chemical Family: Antimuscarinic
CAS Number: 124937-52-6
Intended Use: Pharmaceutical ingredient, overactive bladder therapy
Supplier Identification: Provided on original packaging or certificate of analysis
Emergency Contact: Company emergency line, CHEMTREC, or local poison control
GHS Classification: Acute toxicity (oral), Category 4; Eye irritation, Category 2A
Signal Word: Warning
Hazard Statements: Harmful if swallowed; Causes serious eye irritation; May cause respiratory irritation; May cause central nervous system effects if improperly handled
Pictograms: Exclamation mark; Health hazard
Precautionary Statements: Avoid breathing dust; Wash hands after handling; Wear protective gloves, eye, and face protection; If exposed or concerned, seek medical advice
Other Hazards: Not classified as an environmental hazard, but pharmaceutical runoff can affect aquatic life
Ingredient: Tolterodine Tartrate
Purity: >98% (by HPLC analysis)
Impurities: Related alkaloids and any unreacted starting materials (variable, typically <0.5%)
Other Components: None added intentionally, trace processing solvents possible in rare cases
Inhalation: Move to fresh air; keep at rest; get medical attention if symptoms (dizziness, headache, respiratory discomfort) develop
Skin Contact: Remove contaminated clothing; wash skin with copious amounts of soap and water; consult a healthcare professional for persistent irritation
Eye Contact: Rinse carefully with water for at least 15 minutes, holding eyelids open; remove contact lenses if present; get medical assistance
Ingestion: Rinse mouth thoroughly; do not induce vomiting; never give anything by mouth to an unconscious person; seek emergency medical advice
Other Notes: Always provide attending medical staff with product label and Safety Data Sheet
Suitable Extinguishing Media: Use water spray, carbon dioxide, dry powder, or alcohol-resistant foam
Unsuitable Extinguishing Media: Direct water stream may spread powders
Specific Hazards: Burning produces carbon monoxide, carbon dioxide, nitrogen oxides, and other hazardous gases
Protective Equipment: Firefighters require self-contained breathing apparatus, full protective clothing
Special Procedures: Evacuate unnecessary personnel; cool containers exposed to flame with water spray
Explosion Sensitivity: Dust in high concentrations can form explosive mixtures with air
Personal Precautions: Avoid contact with skin, eyes, clothing; ventilate area; wear appropriate PPE
Environmental Precautions: Stop spill from entering drains, sewers, or natural waterways; notify authorities if contamination occurs
Cleanup Methods: Scoop up spilled material using non-sparking tools; avoid creating dust clouds; wipe down area with suitable solvent placed in chemical waste container; properly dispose of collected material
Decontamination: Clean surfaces with approved detergent solution to remove residues
Safe Handling: Use exclusively in chemical fume hood or with local exhaust; minimize dust generation; practice good industrial hygiene
Incompatible Materials: Strong oxidizers, strong acids, strong bases, direct sunlight
Storage Conditions: Store in tightly closed original container, away from heat and moisture, at 2-8°C
Special Packaging Notes: Use containers that do not permit ingress of air or moisture to preserve substance quality
Employee Training: Ensure all handlers read and understand Safety Data Sheet before use
Engineering Controls: Mechanical exhaust recommended; containment and closed transfer systems minimize worker exposure
Exposure Limits: No established occupational exposure limits; treat as hazardous; practice ALARA (as low as reasonably achievable) principle
Respiratory Protection: NIOSH-approved P95 or better particulate respirator in case of dust or inadequate ventilation
Eye Protection: Chemical safety goggles
Skin Protection: Nitrile or neoprene gloves, laboratory coats, and long pants
Other Controls: Wash hands thoroughly after handling before eating, drinking, or smoking
Appearance: White to off-white crystalline powder
Odor: Odorless or faint, musty odor
pH: Approximately 5.0–6.0 (aqueous solution, 1%)
Melting Point: 210–220°C (decomposition)
Boiling Point: Not applicable (decomposes before boiling)
Solubility: Freely soluble in water and ethanol; slightly soluble in chloroform; insoluble in ether
Vapor Pressure: Negligible at ambient conditions
Partition Coefficient: logP ~ 1.8–2.1
Flash Point: Not available
Density: Not determined
Other Characteristics: Stable under recommended conditions; hygroscopic in open air
Stability: Stable in original sealed packaging under recommended temperature
Chemical Reactivity: Reacts with strong oxidizing agents, strong acids, bases
Hazardous Decomposition Products: Produces carbon monoxide, carbon dioxide, nitrogen oxides upon thermal decomposition
Polymerization: No risk of hazardous polymerization under normal conditions
Conditions to Avoid: Moisture, elevated temperatures, open flame, incompatible chemicals
Acute Oral Toxicity (Rat, LD50): 665–900 mg/kg
Category: Toxic if swallowed; possible central nervous system depression and antimuscarinic symptoms
Inhalation: May cause respiratory tract irritation
Skin Contact: May induce mild irritation or allergic response in sensitive individuals
Eye Contact: Severe irritation possible, especially in powder form
Cancer Risk: No known carcinogenic properties; not listed by IARC, NTP, ACGIH
Reproductive Effects: Animal data suggest possible reproductive toxicity at high doses
Other Effects: Overdose leads to anticholinergic syndrome; medical monitoring recommended for workplace exposure
Ecotoxicity: Not expected to bioaccumulate but can affect aquatic organisms at trace levels; risk for chronic low-level exposure in pharmaceutical wastewater
Persistence and Degradation: Moderate persistence in soil and water; undergoes slow biodegradation
Mobility: Likely to migrate in aquatic environments if released
Aquatic Toxicity Data: EC50 (daphnia, 48h): >90 mg/L
Other Information: Avoid environmental release, especially in bulk processing or disposal scenarios
Waste Treatment: Treat as pharmaceutical hazardous waste; incinerate in approved facility
Container Disposal: Triple rinse containers before disposal; consult local authorities for acceptable practices
Regulatory Considerations: Follow all federal, state, and local regulations governing pharmaceutical or laboratory waste
Avoid Discharge: Never flush large quantities into sewer or surface water
UN Number: Not regulated as a dangerous good in small quantities
Shipping Name: Tolterodine Tartrate, pharmaceutical solid, not otherwise specified
Hazard Class: Not classified for transport under most international guidelines (IATA, IMO, DOT)
Packing Group: Not assigned
Special Transport Conditions: Keep in tightly sealed containers; protect from humidity, physical shock
Reportable Quantity: Not applicable under US DOT; always check national rules for pharmaceuticals
OSHA Status: Not specifically listed; keep workplace exposure as low as reasonably achievable
TSCA Inventory: Research and pharmaceutical use only; not listed for commercial bulk use
WHMIS (Canada): Not specifically classified, controlled product
EC Classification: Not classified as a dangerous substance under the EEC directive
Other Regulations: Prescription pharmaceutical substance; production and sale governed by FDA, EMA, and similar agencies worldwide
Labeling Requirements: Product and workplace labels must state hazard warnings and handling precautions
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