Product Name: Tolterodine Tartrate
Chemical Name: (R,R)-2-[(Diisopropylamino)ethyl]-4-(hydroxymethyl)phenol L-tartrate
CAS Number: 124937-52-6
Manufacturing Use: Pharmaceutical preparation used for urinary incontinence and overactive bladder remedies
Recommended Use: Prescription medication for easing symptoms of urge incontinence, urgency, and urinary frequency
Manufacturer Contact: Supplier or manufacturer name, address, and emergency contact phone number
Emergency Phone: Local emergency response hotline details for handling exposure or accident
SDS Number: Internal reference for documentation and compliance purposes
Classification: Not classified as hazardous under GHS criteria, but can irritate skin, eyes, and mucous membranes
Hazard Statements: Can cause irritation on direct contact; ingestion may cause gastrointestinal discomfort, headache, or drowsiness
Pictogram: Exclamation mark (for skin/eye irritation), not universally required for pharmaceuticals
Signal Word: Warning
Precautionary Statements: Avoid inhalation, ingestion, and contact with skin or eyes; always wear protective gear when handling bulk
Chemical Identity: Tolterodine Tartrate
Concentration: 100% (or as specified for the drug substance formulation)
Other Components: Pharmaceutical tablets or capsules may contain microcrystalline cellulose, lactose, povidone, magnesium stearate, and other inactive excipients (amounts and identities based on manufacturer specifications)
Hazardous Impurities: None known in therapeutic grade product; manufacturing residues regulated to pharmacopeial standards
Inhalation: Move person outside to fresh air; assist breathing if needed; seek immediate medical attention in case of adverse reaction
Skin Contact: Remove contaminated clothing; wash skin thoroughly with soap and water; consult physician if irritation occurs or persists
Eye Contact: Rinse eyes carefully with water for at least 15 minutes; hold eyelids apart; remove contact lenses if present and easy to do; call a doctor
Ingestion: Rinse mouth; do not induce vomiting; observe for symptom onset like dizziness or nausea; immediately contact poison center or medical services for advice
Most Important Symptoms: Possible allergic reaction; drowsiness, dry mouth, blurred vision, abdominal pain, urinary retention are possible upon overdose
Suitable Extinguishing Media: Water spray, alcohol-resistant foam, dry chemical powder, or carbon dioxide extinguishers
Special Hazards: Not highly flammable; hazardous vapors may form in fire such as carbon oxides, nitrogen oxides
Advice for Firefighters: Wear self-contained breathing apparatus, full protective clothing; prevent water runoff from contaminating environment; cool containers with water spray
Personal Precautions: Wear gloves, goggles, lab coat or apron; minimize dust formation; ventilate area properly
Environmental Precautions: Avoid run-off into drains, surface water, or soil; contain any liquid or powder spillage immediately
Clean-Up Methods: Sweep up powder or collect spilled material with damp cloth; place in tightly closed labeled containers for proper disposal; wash spill area with water and detergent after collection
Notification: Report significant spills to local authorities as required by law or regulation
Safe Handling: Handle away from food, beverages, and incompatible materials; avoid inhalation and direct contact with skin or eyes; keep out of reach of unauthorized personnel
Storage Conditions: Store in original container, tightly closed, at room temperature (15-30°C) and away from direct sunlight, moisture, and strong oxidizing agents
Other Precautions: Allow only trained staff to handle bulk chemical; assure good ventilation in storage and handling areas; keep inventory control records
Engineering Controls: Use local exhaust or general dilution ventilation to control airborne particles
Exposure Limits: Occupational exposure limits for Tolterodine Tartrate not established; minimize dust and avoid inhalation
Personal Protective Equipment: Lab coat or gown, suitable gloves (nitrile, latex), safety glasses or goggles, dust mask or respirator for significant exposure
Hygienic Practices: Wash hands after handling; remove and wash contaminated clothing before reuse; do not eat, drink, or smoke in work area
Monitoring: Routine air monitoring not usually necessary at therapeutic handling levels; monitor and control dust in manufacturing
Appearance: White to off-white powder or crystalline solid; tablets may be color-coated depending on manufacturer
Odor: Odorless or weak, characteristic medicinal scent
Solubility: Freely soluble in water and ethanol; insoluble in hexane
Melting Point: Range of approximately 211–217°C (decomposes)
Molecular Formula: C22H31NO4·C4H6O6
Molecular Weight: 475.6 g/mol (tartrate salt)
pH: Not applicable in pure form; in solution, roughly neutral to mildly acidic
Other Data: Stable in recommended storage conditions
Chemical Stability: Stable under standard storage conditions; avoid excessive light, heat, and humidity
Reactivity: Non-reactive under normal use; avoid mixing with strong oxidizing agents
Possible Decomposition Products: Carbon monoxide, carbon dioxide, nitrogen oxides in case of fire or extreme thermal decomposition
Hazardous Polymerization: Will not occur
Routes of Exposure: Oral, inhalation, dermal, ocular
Acute Effects: Headache, dizziness, dry mouth, blurred vision, constipation, urinary retention if ingested in large quantities
Chronic Effects: No data showing carcinogenicity or mutagenicity at therapeutic doses; possible risk with deliberate misuse
Toxicity Data: Oral LD50 (rat): Approximately 903 mg/kg (base), showing relatively low acute toxicity relative to pharmaceuticals
Additional Risk Groups: Pregnant women, children, and those with pre-existing kidney, liver, or heart conditions have heightened sensitivity
Signs of Overexposure: CNS depression, tremor, irregular heartbeat, ataxia
Ecotoxicity: Limited specific studies; may be harmful to aquatic organisms based on structural analogs
Persistence and Degradability: Likely persistent under environmental conditions; slow biodegradation rates for this class of pharmaceuticals
Bioaccumulative Potential: Low likelihood of bioaccumulation in aquatic or soil organisms
Mobility in Soil: Expected to exhibit moderate mobility in soil, depending on formulation and solubility
Other Adverse Effects: Trace pharmaceutical residues can disrupt aquatic environments; wastewater management important to curb impact
Waste Handling: Dispose of Tolterodine Tartrate and contaminated packaging via approved pharmaceutical waste contractors; do not dispose in regular household waste
Safe Disposal Methods: Incineration preferred for bulk quantities to destroy active pharmaceutical residue; triple rinse containers before disposal
Environmental Cautions: Prevent entry into sewers, groundwater, or surface water
Regulatory Requirements: Comply with national and regional pharmaceutical waste management regulations for disposal and record-keeping
UN Number: Not assigned for this pharmaceutical bulk chemical
Proper Shipping Name: Tolterodine Tartrate (as reference, not hazardous under standard shipping protocols)
Transport Hazard Class: Not classified as dangerous goods by IATA, IMDG, or ADR codes
Packaging Instructions: Store in sealed, labeled containers; avoid physical damage and exposure to moisture
Transport Precautions: Keep away from heat and direct sunlight; secure to prevent accidental spills or breakage; ensure documentation accompanies all shipments
Safety, Health, and Environmental Regulations: Substance listed under pharmaceutical active substances and controlled by national drug regulations
OSHA Status: Not regulated as a hazardous chemical under the OSHA Hazard Communication Standard, but safe handling practices apply
TSCA Status: Not listed as a chemical substance under the United States TSCA Inventory
EINECS/ELINCS: Not listed on European inventories for non-industrial chemical use
Other Regulatory Notes: Substance subject to registration, evaluation, authorization, and restriction under pharmaceutical and environmental regulations; check regional requirements to ensure compliance in manufacturing, import, use, and disposal
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