Product name: Tolterodine L-Tartrate
Chemical Formula: C22H31NO•C4H6O6
CAS Number: 124937-52-6
Intended Use: Pharmaceutical ingredient used for treatment of overactive bladder
Supplier Information: Pharmaceutical manufacturer or distributor address, emergency contact number, technical support line
Synonyms: Tolterodine tartrate, Detrol-L-Tartrate
GHS Classification: Acute toxicity (oral, dermal), specific target organ toxicity (single and repeated exposure)
Hazard Statements: May cause serious eye irritation, skin irritation, may be harmful if swallowed
Label Elements: Exclamation mark pictogram indicating hazard, signal word "Warning"
Potential Health Effects: May affect central nervous system, dry mouth, blurred vision, drowsiness with large dose contact
Environmental Hazards: May be harmful to aquatic life with prolonged exposure
Main Component: Tolterodine L-Tartrate (approximately 99% purity)
Impurities: Trace synthetic byproducts in the lower percentage range
Molecular Weight: Approximately 475.6 g/mol
Component Breakdown: Active pharmaceutical ingredient with no known stabilizers or additives
Eye Contact: Rinse eyes gently with water for at least 15 minutes, remove contact lenses if possible
Skin Contact: Immediately wash exposed area with mild soap and water, remove contaminated clothing, seek medical attention if irritation persists
Inhalation: Move affected individual to fresh air, provide artificial respiration if needed, contact medical assistance if symptoms develop
Ingestion: Rinse mouth with water, do not induce vomiting unless instructed by medical personnel, seek immediate medical attention
Suitable Extinguishing Media: Water spray, dry chemical powder, carbon dioxide, alcohol-resistant foam
Specific Hazards: Combustion may release toxic fumes including oxides of carbon, nitrogen-containing gases
Protective Equipment: Full fire-resistant clothing, self-contained breathing apparatus
Special Procedures: Prevent runoff from fire control measures from entering sewers or water sources
Personal Precautions: Use gloves, lab coat, chemical splash goggles, dust mask if powder forms
Environmental Precautions: Prevent spillage from reaching drains, soil, or water sources
Containment Methods: Absorb with inert material like sand or vermiculite, collect into sealed container for disposal
Cleanup Procedures: Wash the area with soap and water, ventilate area well
Handling: Work under chemical fume hood or well-ventilated area, avoid breathing dust, avoid contact with skin, eyes, and clothing, wash hands thoroughly after use
Storage: Keep container tightly closed in a cool, dry place, store away from incompatible chemicals such as strong oxidizers, acids or bases, prevent exposure to sunlight and moisture
Special Precautions: Limit exposure, store in clearly labeled containers, do not use storage areas for food or drink
Exposure Limits: No established occupational exposure limits exist for Tolterodine L-Tartrate
Engineering Controls: Facilities should have eyewash stations and safety showers nearby, ensure adequate ventilation
Personal Protective Equipment: Wear safety goggles, chemical-resistant gloves, lab coat, dust mask if handling fine powder
Hygiene Measures: Wash hands, forearms, exposed areas after handling, remove contaminated clothing
Appearance: White to off-white crystalline powder
Odor: Practically odorless
Solubility: Slightly soluble in water, soluble in methanol and ethanol
pH: Slightly acidic in aqueous solution
Melting Point: 210–215°C
Boiling Point: Decomposes before boiling
Vapor Pressure: Not considered volatile
Partition Coefficient (Log P): Data not available due to ionic tartrate content
Flash Point: Not flammable under normal laboratory conditions
Chemical Stability: Stable under recommended storage conditions
Reactivity: No hazardous reactions with most common substances under normal conditions
Conditions to Avoid: Excessive heat, direct sunlight, moisture, incompatible chemicals (strong oxidizers, acids, bases)
Hazardous Decomposition Products: May produce oxides of carbon, nitrogen-containing gases upon thermal decomposition
Incompatible Materials: Strong oxidizing materials, strong acids and bases
Acute Oral Toxicity: LD50 values in animals fall between 500–2000 mg/kg (species dependent)
Routes of Exposure: Inhalation, skin absorption, ingestion, eye contact
Symptoms of Exposure: Drowsiness, dry mouth, blurred vision, gastrointestinal discomfort, rarely allergic reactions
Long-term Risks: Studies have not shown mutagenicity or carcinogenicity at typical clinical exposure levels
Other Effects: Prolonged contact may increase risk of symptoms, especially with pre-existing health concerns
Fate and Distribution: Expected to have limited mobility in soil and water due to low solubility
Persistence and Degradability: Not readily biodegradable in the environment
Aquatic Toxicity: Potential toxic effects on aquatic life in concentrated forms
Bioaccumulative Potential: Low potential for bioaccumulation
Other Adverse Effects: Disposal or uncontrolled release could have negative impact on water sources, seek minimization
Waste Handling: Dispose of material through licensed hazardous waste disposal contractor
Packaging Disposal: Contaminated packaging should be disposed the same way as the substance
Precautions: Do not release into sewer systems, surface waters, or general waste
Regulatory Compliance: Follow local, national, and international regulations for pharmaceutical waste
UN Number: Not classified as hazardous for transport under most regulations
Transport Hazard Class: Not regulated as a dangerous good
Packing Group: Not applicable
Special Precautions: Avoid extremes of temperature and moisture during transport, keep containers sealed and labeled
Inventory Status: Listed in most pharmaceutical regulatory inventories (refer to specific country database)
Labeling Requirements: Subject to workplace safety labeling for health hazards
OSHA: Not specifically listed under hazardous chemicals, but handle with standard pharmaceutical controls
Other Regulations: Compliant with EU REACH, US TSCA restrictions not applicable unless adulterated
Additional Information: Users should review local regulations for up-to-date restrictions or allowances
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