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Material Safety Data Sheet for Eluxadoline

Identification

Product Name: Eluxadoline
Chemical Name: (5-[[[(2S)-2-amino-3-(4-carboxybenzyl)propanoyl]amino]methyl]-2-methoxybenzoic acid
CAS Number: 1243583-85-8
Synonyms: Viberzi
Recommended Use: Medicinal product for irritable bowel syndrome with diarrhea
Manufacturer: Refer to product packaging
Contact Number: Refer to manufacturer label for emergencies

Hazard Identification

GHS Classification: Not classified as hazardous according to current EU regulations
Hazard Statements: Non-hazardous for acute exposure; chronic occupational exposure data limited
Precautionary Statements: Avoid inhalation of powder; prevent contact with eyes and skin
Emergency Overview: Not flammable or explosive; take standard laboratory care
Possible Health Effects: May cause mild, reversible irritation to eyes and skin
Label Elements: Not a hazardous substance, no required pictograms
Medical Conditions Aggravated: Allergic reactions possible in sensitive individuals

Composition / Information on Ingredients

Eluxadoline 99% Purity
Molecular Formula: C32H35N5O5
Molecular Weight: 569.7 g/mol
Impurities: Pharmaceutical-grade materials, typical trace < 1% by weight
Other Ingredients: None for the active ingredient; excipients listed on finished product insert
OSHA Hazardous Components: No OSHA-regulated components in raw substance

First Aid Measures

Inhalation: Move person to fresh air; seek medical attention for symptoms
Skin Contact: Wash with soap and water; remove contaminated clothing; monitor for irritation
Eye Contact: Rinse cautiously with water for several minutes; remove contact lenses if present
Ingestion: Seek immediate medical attention; do not induce vomiting
Symptoms: Mild irritation possible; no acute toxicity at trace levels used in labs
Medical Attention: Medical observation recommended if large quantities inhaled or ingested

Fire-Fighting Measures

Suitable Extinguishing Media: Water spray, dry powder, foam, carbon dioxide
Specific Hazards: Combustion may produce carbon oxides, nitrogen oxides
Special Protective Equipment: Wear self-contained breathing apparatus and full protective gear
Advice for Firefighters: Avoid inhaling fumes; contain run-off to prevent contamination
Hazardous Combustion Products: Carbon monoxide, carbon dioxide, nitrogen compounds

Accidental Release Measures

Personal Precautions: Wear gloves, protective goggles, lab coat
Spill Cleaning Methods: Collect powders with damp cloths, avoid raising dust
Environmental Precautions: Prevent release into drains; sweep up promptly
Decontamination Procedures: Use moistened absorbent for liquids and residues; ventilate area
Disposal: Place all collected material in sealed, labeled container for later handling

Handling and Storage

Safe Handling Advice: Use standard laboratory safety procedures; avoid dust generation
Storage Conditions: Store tightly closed in dry, well-ventilated area at room temperature
Incompatible Materials: Strong oxidizers, reducing agents, acids
Segregation: Store away from food, beverages, and incompatible chemicals
Technical Measures: Use only in areas with appropriate chemical ventilation

Exposure Controls and Personal Protection

Exposure Limits: No established occupational limits for eluxadoline; minimize unintentional exposure
Engineering Controls: Laboratory fume hood, local exhaust ventilation recommended
Personal Protective Equipment: Gloves (nitrile or latex), safety glasses, laboratory coat
Hygiene Measures: Wash hands thoroughly after handling
Environmental Monitoring: Not typically required in standard laboratory setting

Physical and Chemical Properties

Appearance: White to off-white powder
Odor: Odorless
Melting Point: Not established for bulk product
Boiling Point: Not applicable (decomposes before boiling)
Solubility: Low in water; soluble in DMSO, methanol
pH: Not available
Vapor Pressure: Negligible
Partition Coefficient: Not available
Evaporation Rate: Not applicable

Stability and Reactivity

Chemical Stability: Stable under recommended storage conditions
Reactivity: Avoid contact with strong oxidizing or reducing agents
Hazardous Reactions: Unlikely in standard use
Decomposition: May produce toxic fumes in fire conditions
Polymerization: Will not occur
Incompatible Materials: Avoid sources of strong acids/bases or oxidizers

Toxicological Information

Acute Toxicity: Low risk in occupational exposures; oral LD50 in rodents above 2,000 mg/kg
Routes of Exposure: Inhalation, skin, ingestion, eyes
Symptoms: Mild irritation possible; unlikely to cause toxicity from single exposure
Chronic Effects: No data for carcinogenicity, reproductive toxicity in humans
Sensitization: Not expected based on available data
Mutagenicity: No mutagenic effects reported in standard test systems
Carcinogenicity: Not recognized by IARC, NTP, OSHA as a carcinogen

Ecological Information

Environmental Fate: No significant environmental hazard indicated in available studies
Persistence/Degradability: Biodegradability data limited; excreted metabolites may persist
Bioaccumulation: No significant potential observed for bioaccumulation
Aquatic Toxicity: Expected to pose minimal risk at environmental concentrations
Ecotoxicity: Data not available for effects on aquatic or terrestrial organisms

Disposal Considerations

Waste Disposal: Dispose of contents/container in accordance with local regulations
Contaminated Packaging: Dispose of as pharmaceutical waste
Special Precautions: Avoid disposal into aqueous systems; collection preferred for incineration
Regulatory Status: Not classified as hazardous waste under RCRA

Transport Information

UN Number: Not regulated as hazardous for transport
Transport Hazard Class: Not classified
Packing Group: Not assigned
Proper Shipping Name: Eluxadoline, not regulated as dangerous goods
Special Precautions: Ship in original packaging; consider temperature stability for bulk transfer

Regulatory Information

U.S. Regulations: Not listed as hazardous under SARA, TSCA, CERCLA
E.U. Regulations: Not classified as hazardous under REACH/CLP
Other International Regulations: Verify compliance with country-specific pharmaceutical control laws
Labeling: Prescription-only medicine; professional handling required
Occupational Health Standards: Practice good industrial hygiene and safety practices