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MSDS for Ropinirole Hydrochloride

Identification

Product Name: Ropinirole Hydrochloride
Chemical Name: 4-[2-(Dipropylamino)ethyl]-1,3-dihydro-2H-indol-2-one hydrochloride
CAS Number: 91374-21-9
Molecular Formula: C16H24N2O·HCl
Molecular Weight: 296.8 g/mol
Synonyms: Ropinirole HCl
Recommended Use: Pharmaceutical intermediate, anti-Parkinson drug
Supplier Details: Manufacturer and distributor contact details on official documentation
Emergency Contact: International Poison Center and local emergency response numbers

Hazard Identification

Classification: Not classified as hazardous under current GHS guidelines for industrial quantities; potential risk as pharmaceutical active
Hazard Statements: Can cause skin and eye irritation, possible effects upon inhalation or ingestion, may affect central nervous system
Pictograms: No mandatory hazard pictogram for bulk non-clinical use
Precautionary Statements: Avoid breathing dust; wash skin thoroughly; use adequate ventilation; seek medical attention if symptoms develop
Target Organs: Central nervous system, gastrointestinal tract
Other Hazards: Exposure above occupational limits can trigger dizziness, nausea, somnolence

Composition / Information on Ingredients

Chemical Identity: Ropinirole Hydrochloride (single ingredient for clinical grade material)
CAS: 91374-21-9
EC Number: Not available
Concentration: 100% for pure substance
Impurities: May include trace process solvents, water, unidentified intermediates, not regarded as hazardous at detection limits

First Aid Measures

Inhalation: Move to fresh air, monitor breathing, administer oxygen if needed, seek immediate medical evaluation
Skin Contact: Remove contaminated clothing, wash affected area with soap and water for at least 15 minutes, seek medical advice for persistent redness or irritation
Eye Contact: Gently flush with lukewarm water for at least 15 minutes, hold eyelids open to ensure thorough rinsing, immediate medical assessment recommended
Ingestion: Rinse mouth thoroughly, do not induce vomiting unless instructed by medical personnel, monitor vital signs, professional medical intervention compulsory
Notes for Physicians: Symptomatic treatment based on clinical presentation, consult poison control center for specific recommendations

Fire-Fighting Measures

Extinguishing Media: Carbon dioxide, dry chemical powder, universal foam, water spray
Special Hazards: Emits toxic fumes on combustion including nitrogen oxides, carbon monoxide, hydrogen chloride
Protective Equipment: Full firefighting suit with positive pressure self-contained breathing apparatus
Specific Tactics: Prevent runoff from entering drains, cool containers exposed to flame, evacuate personnel from area
Combustion Byproducts: Chlorinated and nitrogenous gases

Accidental Release Measures

Personal Precautions: Utilize appropriate personal protective equipment, prevent dust generation, avoid skin and eye contact, evacuate unnecessary personnel
Environmental Precautions: Prevent discharges into surface water or drains, retain and dispose according to local regulations
Cleanup Methods: Small spills: dampen and scoop material to sealable container, wash area with plenty of water. Larger spills: contain with absorbent, collect and dispose at approved waste facility
Decontamination: Use appropriate detergent solutions, prevent aerosolization, ventilate enclosed areas thoroughly

Handling and Storage

Handling: Wear protective clothing and gloves when manipulating, limit dust exposure, keep containers closed when not in use, handle under local exhaust ventilation, wash hands after use
Storage Conditions: Store in air-tight containers, keep away from light, heat, moisture, and incompatible substances, prefer cool and dry warehouse spaces, segregate from strong acids and bases
Incompatible Materials: Avoid contact with oxidizing substances and strong acids
Special Packaging: Use containers made of materials resistant to moisture ingress, label clearly for laboratory and industrial stock
Occupational Hygiene: No food or drink in work area; immediately remove contaminated clothing

Exposure Controls and Personal Protection

Exposure Limits: No strict occupational exposure limits set for Ropinirole Hydrochloride, strong recommendations to minimize worker exposure
Engineering Controls: Employ local exhaust ventilation, use fume hoods or enclosures for powder operations
Personal Protective Equipment: Nitrile gloves, safety goggles or chemical splash glasses, protective lab coat, optional respirators under dusty conditions (NIOSH-certified mask recommended)
Environmental Protection: Prevent release into soil or drainage systems, use spill containment for large-scale handling
Hygiene Measures: Avoid touching face or exposed skin, wash hands thoroughly after handling, regular laundering of work clothes

Physical and Chemical Properties

Appearance: White to pale yellow crystalline powder
Odor: No significant odor
pH: Not applicable for solid substance
Melting Point: Between 243°C and 250°C (decomposition may occur above this range)
Boiling Point: Decomposes before boiling
Solubility: Freely soluble in water, slightly soluble in alcohol, insoluble in organic solvents
Vapor Pressure: Negligible
Density: Approximately 1.18 – 1.21 g/cm3
Flash Point: Not determined for powder
Partition Coefficient: LogP (octanol-water): -0.47 (for base)

Stability and Reactivity

Chemical Stability: Stable under recommended storage conditions, maintains structural integrity away from acids and moisture
Hazardous Reactions: None documented under normal usage, reacts with strong oxidizers and acids causing degradation
Decomposition Products: On heating emits toxic gases: nitrogen oxides, hydrogen chloride, carbon monoxide, carbon dioxide
Conditions to Avoid: Elevated temperatures, direct sunlight, humidity, acidic environments
Reactivity: No dangerous polymerization anticipated

Toxicological Information

Routes of Exposure: Inhalation, skin contact, eye contact, ingestion
Acute Toxicity: Oral LD50 (rat): >1000 mg/kg
Health Effects: Central nervous system effects including drowsiness, nausea, fatigue; possible skin/eye irritation; rare allergic responses
Chronic Exposure: Prolonged or repeated exposure may impact neurological function; not classified as carcinogenic, mutagenic, or reprotoxic under current data
Medical Symptoms: Gastrointestinal upset, headache, confusion, somnolence
Sensitization: Not established in animal or clinical reports

Ecological Information

Aquatic Toxicity: Low to moderate risk, avoid uncontrolled environmental discharge
Persistence and Degradability: May not readily biodegrade, limited specific biodegradation data available
Bioaccumulation: Potential for low bioaccumulation (LogP <0)
Mobility: Likely to possess moderate mobility in water, restrict runoff
Ecotoxic Effects: Limited effects on aquatic and terrestrial organisms expected at laboratory concentrations, data for chronic exposure sparse

Disposal Considerations

Waste Treatment Methods: Dispose of via authorized chemical waste contractor, do not discharge to sewer systems
Disposal Guidance: Incinerate in accordance with regional and national requirements, avoid open-air burning
Contaminated Packaging: Triple rinse then offer for controlled disposal, never reuse containers for food or drink
Precautions: Offer surplus and non-recyclable solutions to licensed disposal company
Legal Compliance: Disposal must meet all applicable local, regional, and international chemical safety and environmental regulations

Transport Information

UN Number: Not assigned for most ground/air transport as non-dangerous
Transport Hazard Class: Not classified as hazardous for transport purposes
Packing Group: Not regulated
Special Precautions: Ship in securely sealed containers, protected from weather, segregated from combustible or incompatible cargo
Environmental Hazards: Not regarded as marine pollutant under IMDG code
Other Precautions: Confirm regulatory status prior to shipment, retain documentation during transit

Regulatory Information

Labelling According to GHS: Not classified; cautionary labelling for pharmaceutical compounds
TSCA Inventory: Not listed
REACH Status (EU): Not subject to registration under exemption for active pharmaceutical ingredients
OSHA: Not listed as hazardous, use prudent laboratory practices
WHMIS (Canada): Not controlled
Other Standards: Meets applicable ICH, FDA, and EMA guidance for identity, purity, and handling for drug substances
Country-Specific Rules: Only available for use by qualified personnel in regulated environments