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Material Safety Data Sheet for Ivabradine Hydrochloride

Identification

Product Name: Ivabradine Hydrochloride
Chemical Name: 3-(3-{[(7S)-3,4-dimethoxybicyclo[4.2.0]octa-1,3,5-trien-7-yl]methyl}dimethylamino)propyl]-3,4-dimethoxybenzene hydrochloride
CAS Number: 148849-67-6
Recommended Use: Pharmaceutical active ingredient
Manufacturer/Supplier: Details specific to your company
Emergency Contact: Refer to local poison control center or safety officer
Synonyms: Procoralan, Corlentor
Molecular Formula: C27H36N2O5·HCl
Molecular Weight: 505.05 g/mol

Hazard Identification

Classification: Not classified as hazardous under GHS criteria; caution required as pharmaceutical active compound
Signal Word: Warning
Hazard Statements: May cause eye, skin, and respiratory irritation; possible effects following accidental ingestion or inhalation include bradycardia and visual disturbances
Pictograms: None needed, general caution
Precautionary Statements: Avoid inhalation, ingestion, and contact with skin and eyes; use under established laboratory protocols
Other Hazards: May cause adverse cardiovascular effects at therapeutic or above-therapeutic levels; environmental persistence noted in some studies

Composition / Information on Ingredients

Substance: Ivabradine Hydrochloride
Concentration: >98% (typical for pharmaceutical raw material)
Impurities: Trace organic compounds, related reaction by-products, water (<1%)
Chemical Nature: Pure substance, not a mixture

First Aid Measures

Inhalation: Move person to fresh air, monitor for symptoms of bradycardia or difficulty breathing, seek medical attention if effects develop
Skin Contact: Remove contaminated clothing; wash exposed area thoroughly with soap and water
Eye Contact: Rinse eyes carefully under running water for at least 15 minutes; consult medical services if irritation persists
Ingestion: Rinse mouth with water; seek immediate medical assistance; do not induce vomiting unless directed by a medical professional
Symptoms: Bradycardia, dizziness, vision changes, nausea; treat symptomatically

Fire-Fighting Measures

Suitable Extinguishing Media: Water spray, carbon dioxide, foam, or dry chemical
Unsuitable Media: Direct high-pressure water jet may disperse powder
Fire/Explosion Hazards: Dust may form explosive mixtures with air if present in high concentrations
Special Protective Equipment: Wear self-contained breathing apparatus and protective gear
Hazardous Combustion Products: Carbon monoxide, carbon dioxide, nitrogen oxides, hydrogen chloride gas

Accidental Release Measures

Personal Precautions: Use personal protective equipment; avoid dust formation; ventilate area
Environmental Precautions: Prevent entry into surface water and drains; notify authorities if large release to environment occurs
Cleanup Methods: Gently sweep up material without creating dust; transfer to closed, labeled waste containers; wash spill site thoroughly
Disposal: Handle as pharmaceutical waste according to local regulations

Handling and Storage

Precautions for Safe Handling: Wear lab coat, gloves, safety goggles; use dust extraction if powders handled in bulk
Hygiene Measures: Wash hands after handling; avoid eating, drinking, or smoking in work area
Storage Conditions: Store at room temperature (15–25°C), tightly sealed in original packaging, protected from moisture and light
Incompatible Materials: Oxidizers, strong acids or bases
Technical Measures: Use in well-ventilated area, minimize dust generation

Exposure Controls and Personal Protection

Occupational Exposure Limits: No specific OEL established; minimize exposure as much as practical
Engineering Controls: Use of fume hood or local exhaust preferred for powder handling
Personal Protective Equipment: Nitrile gloves, safety glasses, laboratory coat; for significant dust quantities, NIOSH-approved respirator
Environmental Exposure: Prevent uncontrolled environmental release, ensure disposal complies with regulations

Physical and Chemical Properties

Appearance: White or almost white crystalline powder
Odor: Odorless
Odor Threshold: Not determined
pH: 3–4 (1% solution in water)
Melting Point: 140–142°C (decomposes)
Boiling Point: Not applicable (decomposes)
Flash Point: Not available
Evaporation Rate: Not determined
Flammability: Not easily flammable
Explosive Limits: Dust explosion possible if dispersed in air
Vapor Pressure: Negligible
Vapor Density: Not determined
Relative Density: About 1.2 g/cm³
Solubility: Soluble in water and ethanol
Partition Coefficient: logP ≈ 3.5 (octanol/water, estimated)
Auto-Ignition Temperature: Not determined
Decomposition Temperature: >140°C
Viscosity: Not applicable

Stability and Reactivity

Chemical Stability: Stable under normal laboratory and storage conditions
Reactivity: No hazardous reactions found under recommended conditions
Hazardous Reactions: Contact with strong oxidizing agents may trigger reaction
Conditions to Avoid: Extreme heat, direct sunlight, moisture, strong acids/alkalis
Hazardous Decomposition Products: Carbon monoxide, carbon dioxide, hydrogen chloride gas, nitrogen oxides
Polymerization: Not anticipated

Toxicological Information

Acute Toxicity: No acute oral or dermal LD50 clearly established in humans or rodents, but estimated as moderate
Skin Corrosion/Irritation: May cause mild skin irritation on contact
Eye Damage/Irritation: May cause temporary discomfort
Respiratory Sensitization: Unlikely, can irritate mucous membranes when dust inhaled
Carcinogenicity: No classification by IARC, NTP, or ACGIH; no evidence for carcinogenicity
Mutagenicity: No evidence in standard tests
Reproductive Toxicity: Not fully evaluated; caution advised for pregnancy
Human Experience: Therapeutic use may lead to bradycardia, visual phenomena (“luminous phenomena” or phosphenes), dizziness, headache, GI discomfort

Ecological Information

Ecotoxicity: Not acutely toxic to aquatic organisms at concentrations likely in the environment
Persistence and Degradability: Limited biodegradation, may persist as pharmaceutical residue
Bioaccumulative Potential: Low for hydrolyzed products; parent compound may bioaccumulate minimally
Mobility in Soil: Moderate, can migrate in surface water
Other Adverse Effects: Entry into water bodies should be minimized to prevent impact on aquatic life

Disposal Considerations

Disposal Methods: Incinerate in approved facility or dispose as hazardous pharmaceutical waste in accordance with regional and national regulations
Contaminated Packaging: Dispose of as unused product; containers must remain sealed for transport or destruction
Precautions for Disposal: Do not allow to reach sewage system, surface or ground water; collection by licensed contractor recommended

Transport Information

UN Number: Not regulated for transport as dangerous goods
UN Proper Shipping Name: Not classified as hazardous
Transport Hazard Class: Not applicable
Packing Group: Not assigned
Environmental Hazards: Not identified as marine pollutant
Special Precautions: Keep containers tightly sealed; protect from physical damage in transit

Regulatory Information

Safety, Health, and Environmental Regulations: Complies with relevant pharmaceutical, health, and chemical management statutes globally
TSCA Inventory: Not listed as it is a pharmaceutical substance
OSHA Hazard Communication: Not classified under OSHA criteria
REACH Status: Exempted for pharmaceutical intermediates
Other Relevant Directives: Ensure workplace safety standards comply with local, regional, and national guidelines on handling and use of active pharmaceutical ingredients