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Product Name: Ropivacaine Hydrochloride
Chemical Name: (S)-(-)-1-propyl-2',6'-pipecoloxylidide hydrochloride monohydrate
Synonyms: Ropivacaine HCl, Naropin
CAS Number: 132112-35-7
Recommended Use: Local anesthetic for regional anesthesia
Manufacturer Details: AstraZeneca Pharmaceuticals LP, 1800 Concord Pike, Wilmington, DE 19803
Emergency Contact: CHEMTREC – US: 1-800-424-9300
Formula: C17H26N2O·HCl·H2O
GHS Classification: Not classified as hazardous per GHS criteria
Signal Word: Warning
Hazard Statements: May cause respiratory irritation, drowsiness, and dizziness if inhaled, harmful if swallowed, can cause allergic reactions in sensitive individuals, possible central nervous system effects
Precautionary Statements: Avoid inhalation, ingestion, and contact with skin or eyes; use only in well-ventilated areas; wash hands thoroughly after handling
Other Hazards: Abuse or misuse can cause systemic toxicity, including cardiovascular and central nervous system effects
Substance: Ropivacaine hydrochloride monohydrate
Active Ingredient: Ropivacaine hydrochloride
Content: >98% by weight
Impurities: Water of hydration (approximately 2%)
Additional Components: None significant for safety disclosure
Molecular Weight: 328.89 g/mol
Eye Contact: Rinse cautiously with water for several minutes, remove contact lenses if present, seek medical attention for persistent irritation
Skin Contact: Wash affected areas with soap and water, remove contaminated clothing, seek medical attention if symptoms develop
Inhalation: Move person to fresh air, keep at rest, obtain medical attention if symptoms arise
Ingestion: Rinse mouth thoroughly with water, do not induce vomiting unless told by medical personnel, get medical advice immediately
Symptoms: Numbness, tingling, twitching, respiratory difficulties, convulsions, hypotension, cardiac arrhythmias
Emergency Notes: Physicians may use standard local anesthetic toxicity treatment protocols
Suitable Extinguishing Media: Water spray, dry chemical, foam, carbon dioxide
Unsuitable Extinguishing Media: No known incompatibilities
Hazards from Combustion Products: May emit toxic or irritating fumes such as carbon monoxide, nitrogen oxides, hydrochloric acid
Protective Equipment: Firefighters should use self-contained breathing apparatus, full protective gear
Special Instructions: Avoid inhaling combustion gases, cool exposed containers with water spray
Personal Precautions: Use appropriate personal protective equipment, avoid breathing dust, ensure adequate ventilation
Spill Procedure: Sweep up spilled material without raising dust, place in secure container for disposal
Environmental Precautions: Prevent entry into drains, water courses, or soil
Decontamination: Clean contaminated surfaces thoroughly with water and detergent
Disposal: Refer to local and national regulations for pharmaceutical waste handling
Handling: Wear suitable gloves, labcoat, and eye protection, handle under local exhaust ventilation, avoid generating dust, avoid direct contact
Storage Conditions: Store at controlled room temperature (15–30°C), keep tightly closed in original container, protect from moisture and light
Incompatible Materials: Strong oxidizers, acids
Transfer Notes: Use dedicated, labeled equipment for pharmaceutical handling
Engineering Controls: Work in chemical fume hood or with local exhaust ventilation, use enclosed systems for larger quantities
Exposure Limits: No OSHA PEL or ACGIH TLV assigned; minimize exposure as a pharmaceutical active ingredient
Respiratory Protection: NIOSH-approved respirator if airborne concentrations risk exposure
Eye / Face Protection: Chemical splash-resistant goggles
Hand Protection: Nitrile or neoprene gloves
Skin Protection: Laboratory coat or protective clothing
Hygiene Measures: Wash thoroughly after handling, do not eat or drink during use
Appearance: White or almost white crystalline powder
Odor: No distinctive odor
pH (1% solution): 4.0–6.0
Melting Point: 250–255°C (decomposes)
Solubility in Water: Freely soluble
Boiling Point: Not applicable (decomposes)
Vapor Pressure: Negligible at room temperature
Density: 1.1–1.2 g/cm3
Partition Coefficient (log P): 2.8
Other Data: Stable under normal conditions of use
Chemical Stability: Stable at recommended storage conditions
Conditions to Avoid: Heat, open flame, moisture, prolonged light exposure
Incompatibility: Strong oxidizers, acids, bases
Hazardous Decomposition: Can form carbon monoxide, carbon dioxide, nitrogen oxides, hydrogen chloride
Polymerization: No known hazardous polymerization
Routes of Exposure: Inhalation, skin, eye, ingestion
Acute Toxicity Data: Oral (rat) LD50: 230 mg/kg; intravenous (rat) LD50: 25 mg/kg
Short-Term Effects: Drowsiness, dizziness, respiratory or cardiac depression in overdose
Long-Term Risks: No evidence of carcinogenicity in limited studies; reproductive and mutagenesis studies show no hazards at therapeutic doses
Occupational Exposure Effects: May cause allergy, sensitization by skin contact
Other Information: Central nervous system and cardiovascular effects at high exposures
Ecotoxicity: Not expected to pose significant environmental hazards at pharmaceutical concentrations
Aquatic Toxicity: Fish LC50 (96h): >100 mg/l (estimated); crustacean EC50: >100 mg/l
Persistence and Degradability: Likely biodegradable
Bioaccumulation: Low potential for bioaccumulation
Mobility in Soil: Moderately mobile, potential to leach if released in bulk
Other Hazards: Avoid uncontrolled release to water systems or soil
Waste Treatment: Must be collected and disposed of as pharmaceutical waste according to applicable regulations
Container Disposal: Empty containers may retain residues; follow local requirements
Methods: Incineration preferred for bulk waste, chemical treatment or landfilling for inertized remains (where allowed)
Precautions: Prevent contamination of municipal landfills or water sources
Regulatory Notes: Adhere to all national and regional waste handling rules
UN Number: Not regulated for transport
Transport Hazard Class: Not classified as dangerous goods
Packing Group: Not applicable
Proper Shipping Name: Ropivacaine Hydrochloride
Marine Pollutant: No
Special Precautions: Avoid exposure to moisture and extreme heat during transport, ensure containers remain tightly closed
OSHA: Not regulated as hazardous
TSCA: Not listed
DSL/NDSL (Canada): Not listed
REACH (Europe): Not registered
California Prop 65: Not listed
WHMIS Classification: Pharmaceutical product exempt
EU Classification: Not classified as dangerous
Other Regulations: May be subject to specific health and safety pharmaceutical code requirements in health care settings
