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Product Name: Pramipexole dihydrochloride monohydrate
Chemical Formula: C10H17N3S•2HCl•H2O
Chemical Family: Dopamine agonist, Phenylthiazole derivative
CAS Number: 104632-26-0
Synonyms: Sifrol, Mirapex, Pexola
Intended Use: Pharmaceutical intermediate, antiparkinsonian agent
Manufacturer: Check specific label for responsible party details
Contact Information: Refer to supplier or manufacturer contact listed on the product label
Classification: Not classified as hazardous according to GHS criteria in most settings, but poses risk if ingested in large quantities
Risk Phrases: Harmful if swallowed, can affect central nervous system
Target Organs: Central nervous system, cardiovascular system
Routes of Exposure: Inhalation, skin or eye contact, ingestion
Hazard Symbol: None required, though accidental overdose may cause significant health hazards
Health Hazards: Nausea, dizziness, hallucination, sleep attacks
Environmental Hazards: No substantial hazard data, chemical should not enter waterways unnecessarily
Chemical Name: Pramipexole dihydrochloride monohydrate
Concentration: Typically 98% or greater in pure form
Impurities: Trace process-related residues, consult certificate of analysis for specific batches
Other Ingredients: Pharmaceutical grade excipients in formulated products; these vary by manufacturer
Molecular Weight: 302.3 g/mol (anhydrous base)
Physical State: Solid crystalline powder
Inhalation: Remove affected individual to fresh air, seek immediate medical attention if symptoms develop
Skin Contact: Wash thoroughly with soap and water, remove contaminated clothing and shoes
Eye Contact: Rinse cautiously with water for several minutes; avoid rubbing; get medical help if irritation persists
Ingestion: Do not induce vomiting unless directed by medical personnel, rinse mouth, consult poison control
Most Important Symptoms: Nausea, headache, confusion, hallucination, sleepiness
Suitable Extinguishing Media: Water spray, dry chemical, carbon dioxide, foam
Unsuitable Extinguishing Media: Direct water jets if dust is present
Specific Hazards: No unusual fire or explosion hazards expected
Thermal Decomposition Products: Carbon oxides, nitrogen oxides, sulfur oxides, hydrogen chloride
Protective Equipment for Firefighters: Self-contained breathing apparatus, full protective gear
Firefighting Instructions: Avoid inhalation of smoke or fumes, use standard firefighting procedures
Personal Precautions: Use personal protective equipment, avoid dust formation, ventilate area
Environmental Precautions: Prevent further leakage or spillage if safe to do so, do not let product enter drains
Methods for Clean-up: Collect spillage by mechanical means or with damp disposable towels, place in suitable container for disposal, wash area thoroughly after cleanup
Spill Reporting: Follow company procedures, notify authorities if large release threatens environment
Handling: Handle in well-ventilated areas, minimize dust generation, use appropriate PPE
Hygiene Measures: Do not eat, drink or smoke when handling the substance, wash hands before breaks and after use
Storage Conditions: Store in tightly closed original container, away from direct sunlight, heat sources, and incompatible chemicals
Temperature: Ambient room temperature recommended unless specified otherwise by the manufacturer
Storage Area: Secure, dry, cool, well-ventilated location protected from unauthorized access or accidental release
Occupational Exposure Limits: No established TLV or OSHA PEL
Engineering Controls: General room ventilation, local exhaust if dust is generated
Respiratory Protection: Use NIOSH-approved respiratory protection if airborne exposure risk exists
Skin Protection: Chemical-resistant gloves
Eye Protection: Safety goggles
Work Practices: Wash hands thoroughly after handling, remove and wash contaminated clothing before reuse
Appearance: White or off-white crystalline powder
Odor: Odorless
pH: Not available in solid form
Melting Point: Approximately 296-298°C (decomposes)
Boiling Point: Decomposes before boiling
Solubility: Freely soluble in water, slightly soluble in ethanol and methanol
Partition Coefficient (log Pow): Data not readily available
Vapor Pressure: Not applicable (solid at room temperature)
Density: Not established for finished form
Other Properties: Stable under recommended storage conditions
Chemical Stability: Stable under normal ambient conditions
Reactivity: No hazardous reactions known under normal use
Conditions to Avoid: Excessive heat, moisture, direct sunlight, open flame
Incompatible Materials: Strong oxidizing agents, acids, bases
Hazardous Decomposition Products: Thermal decomposition can produce carbon oxides, sulfur oxides, nitrogen oxides, hydrochloric acid
Polymerization: Will not occur under normal conditions
Likely Routes of Exposure: Inhalation, skin, eyes, ingestion
Acute Toxicity: Oral LD50 (rat) > 400 mg/kg (data may vary by source)
Chronic Effects: Prolonged exposure may result in cardiovascular, psychological, or neurological symptoms
Sensitization: Not known to cause sensitization reactions
Symptoms: Drowsiness, confusion, impulse control problems, drop in blood pressure, hallucinations at higher doses
Carcinogenicity: Not listed as a carcinogen by IARC, NTP or OSHA
Mutagenicity and Reproductive Toxicity: No mutagenic or reproductive toxicity observed in animal studies at therapeutic doses
Ecotoxicity: Limited data available; avoid uncontrolled environmental release
Mobility in Soil: Not determined, expected to have low mobility at pharmaceutical concentrations
Persistence and Degradability: No detailed biodegradability data, likely persistent in the environment if released in bulk
Bioaccumulation: Low potential
Other Adverse Effects: Unknown effects on aquatic life, avoid contaminating natural waters
Waste Disposal Methods: Dispose of as hazardous waste in accordance with local, regional, and national regulations
Unused Product: Incinerate or send to licensed waste facility
Contaminated Packaging: Triple rinse, then landfill or incinerate containers in accordance with regulations
Precautions: Avoid environmental release, keep away from drains and watercourses
UN Number: Not regulated as a hazardous material for transport purposes
Proper Shipping Name: Pharmaceutical product, non-hazardous
Hazard Class: Not applicable
Packing Group: Not applicable
Special Precautions: Protect from physical damage, store securely during shipment
Transport Labels: No specific transport hazard labeling requirements
TSCA Status: Pramipexole is not listed on the TSCA inventory as a finished pharmaceutical
FDA Status: Approved for medical use in the United States
REACH Registration: Not applicable for finished medicinal products
Other Regulations: Subject to pharmaceutical control in most jurisdictions
Workplace Classification: Not classified as hazardous by OSHA but requires good laboratory practices
WHMIS (Canada): Not a controlled product
DSL/NDSL (Canada): Not listed
Other Requirements: Users must follow all applicable federal, state, or regional health and safety regulations
