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Material Safety Data Sheet for Dextromethorphan Hydrobromide Monohydrate

Identification

Product Name: Dextromethorphan Hydrobromide Monohydrate
Chemical Formula: C18H25NO•HBr•H2O
CAS Number: 6700-34-1
Synonyms: DXM, Dextromethorphan HBr Monohydrate
Manufacturer: Check supplier details on packaging
Recommended Use: Pharmaceutical active ingredient (cough suppressant)
Contact Information: Manufacturer’s address and emergency phone on label

Hazard Identification

Classification: Acute toxicity (Oral) Category 3, Eye irritation Category 2A, Specific target organ toxicity (single exposure) Category 3
Signal Word: Danger
Hazard Statements: Toxic if swallowed, causes serious eye irritation, may cause drowsiness or dizziness
Pictograms: Skull and crossbones, exclamation mark
Precautionary Statements: Avoid inhalation, wash hands after handling, store in well-ventilated place, wear protective clothing and eye protection
Symptoms of Exposure: Nausea, vomiting, respiratory depression, dizziness, disorientation
Environmental Hazard: Harmful to aquatic life with long lasting effects

Composition / Information on Ingredients

Chemical Name: Dextromethorphan Hydrobromide Monohydrate
Percent Composition: 100% (active pharmaceutical ingredient)
Impurities/Additives: Contains water of hydration, trace solvates possible from manufacturing
Molecular Weight: 370.33 g/mol
EC Number: 200-698-2

First Aid Measures

Inhalation: Move person to fresh air, keep at rest, seek medical attention for breathing difficulty
Skin Contact: Remove contaminated clothing, rinse skin thoroughly with soap and water
Eye Contact: Rinse cautiously with water for several minutes, remove contact lenses if present, continue rinsing, consult an ophthalmologist
Ingestion: Rinse mouth, contact a poison center or physician immediately, do not induce vomiting unless instructed
General Advice: Immediate medical attention is required for large exposures, always bring product container or label when seeking assistance
Self-protection for First Aiders: Use personal protective equipment, avoid direct contact

Fire-Fighting Measures

Suitable Extinguishing Media: Use water spray, dry chemical, carbon dioxide, or foam for surrounding fire
Hazardous Combustion Products: Hydrogen bromide, nitrogen oxides, carbon oxides, toxic fumes
Firefighting Instructions: Avoid inhaling vapors or dust, use breathing apparatus and protective clothing
Special Hazards: Combustible dust when finely divided, potentially explosive upon dust-air mixture ignition
Move Containers: Remove containers from fire area if safe, prevent run-off from entering drains or watercourses

Accidental Release Measures

Personal Precautions: Wear suitable respiratory protection, avoid dust formation, avoid contact with eyes and skin, evacuate area if necessary
Environmental Precautions: Prevent material from entering sewers or waterways, inform environmental agencies if significant quantities spill
Methods for Containment and Clean-Up: Collect spill with non-sparking tools, sweep up and place in suitable waste container, ventilate area thoroughly, dispose of as hazardous waste
Decontamination: Wash contacted area with soap and water after clean-up, ensure contaminated tools are decontaminated

Handling and Storage

Handling: Wear personal protection including gloves, lab coat, goggles, avoid raising dust, prevent ingestion and inhalation, keep away from food or drink
General Hygiene: Do not eat, drink, or smoke during use, keep containers tightly closed when not in use, label all containers clearly
Storage Conditions: Store in original container, keep in cool, dry, well-ventilated area, protect from direct sunlight, moisture, and incompatible materials such as oxidizers
Temperature Restrictions: Ideally store below 25°C (77°F), avoid freezing or high humidity
Incompatibilities: Avoid strong oxidizing agents, acids, alkalis

Exposure Controls and Personal Protection

Occupational Exposure Limits: No OSHA PEL or ACGIH TLV established; minimize exposure to dust and vapors
Engineering Controls: Work in well-ventilated area, use local exhaust or fume hood, laboratory safety protocols should be enforced
Personal Protective Equipment: Safety goggles, gloves (nitrile or equivalent), lab coat, NIOSH-approved particulate respirator for dusty conditions
Environmental Exposure Controls: Prevent release to environment, use closed systems wherever possible, ensure spill kits and eyewash stations available

Physical and Chemical Properties

Appearance: White or almost white crystalline powder
Odor: Odorless or faint chemical smell
Odor Threshold: Not established
pH: Approximately 5–6.5 (1% solution in water)
Melting Point: Around 126–130°C (with decomposition)
Boiling Point: Not applicable (decomposes)
Solubility: Freely soluble in water, soluble in alcohol, practically insoluble in ether
Vapor Pressure: Negligible at room temperature
Relative Density: ~1.0–1.2
Partition Coefficient (n-octanol/water): Not available
Flash Point: Not flammable under normal conditions
Auto-Ignition Temperature: Not available
Evaporation Rate: Not applicable
Explosive Limits: Not established

Stability and Reactivity

Chemical Stability: Stable under recommended storage conditions, sensitive to light and moisture
Reactivity: No dangerous reactions known under normal use
Hazardous Reactions: May react with strong oxidizers, formation of toxic fumes possible in fire
Conditions to Avoid: Heat, moisture, strong acids, strong bases, light
Incompatible Materials: Oxidizing agents, strong acids, alkalis
Hazardous Decomposition Products: Hydrogen bromide, nitrogen oxides, carbon monoxide, carbon dioxide, other toxic vapors

Toxicological Information

Routes of Exposure: Ingestion, inhalation, skin and eye contact
Acute Toxicity: LD50 (oral, rat): estimated 200–405 mg/kg
Chronic Effects: Prolonged or repeated exposure may cause central nervous system effects
Symptoms: Dizziness, euphoria, confusion, hallucinations, respiratory depression, nausea
Carcinogenicity: Not classified as a carcinogen by IARC, NTP, or OSHA
Mutagenicity: Negative in standard genotoxicity assays
Reproductive Toxicity: No expected reproductive toxicity at therapeutic doses
Sensitization: No reports of skin or respiratory sensitization
Target Organs: Central nervous system, respiratory system
Further Information: Effects may be delayed after exposure, seek medical review for significant exposure incidents

Ecological Information

Ecotoxicity: Harmful to aquatic organisms, may cause long-term adverse effects in the aquatic environment, limited biodegradability
Aquatic Toxicity: LC50 (Fish 96h): not specifically determined for this compound, structurally similar substances indicate moderate toxicity
Mobility in Soil: Moderate mobility, potential to leach in aqueous environments
Persistence and Degradability: Compound may not rapidly degrade, can persist in sediment
Bioaccumulative Potential: Low, based on molecular weight and water solubility
Other Adverse Effects: Avoid uncontrolled release into environment, no known ozone depletion effect

Disposal Considerations

Waste Treatment Methods: Dispose of unused or waste material via licensed hazardous chemical disposal contractor
Product Disposal: Do not dispose through household waste, avoid release into environment
Contaminated Packaging: Rinse containers and dispose through chemical waste stream, follow local/national regulations
Recycling: Not recommended, destroy according to regulations
Environmental Precautions: Prevent material and solutions from entering ground or surface waters

Transport Information

UN Number: Not classified as a dangerous good for transport in the US (DOT), EU (ADR/RID), or shipping (IMDG, IATA) at therapeutic levels
Proper Shipping Name: Dextromethorphan Hydrobromide Monohydrate or chemical name
Transport Hazard Class: Not regulated
Packing Group: Not assigned
Special Precautions: Ensure containers are secure, avoid physical damage, label all packaging and transport information per national and international guidelines
Environmental Hazards: Product poses minor risk to aquatic environments if large quantities released inadvertently during transport

Regulatory Information

US TSCA: Listed
EU REACH: Exempt as pharmaceutical active
OSHA Hazard Communication Standard: Toxic substance
WHMIS Classification (Canada): D2A (very toxic material) and D2B (toxic material causing other chronic effects)
Other Relevant Regulations: Conforms to FDA, EMA, and WHO standards for use as pharmaceutical active ingredient when handled as per guidelines
Labelling Requirements: Product labels must show hazard warnings, manufacturer details, batch number, and expiry date
Restriction: Use only by qualified personnel, subject to prescription control or regulatory approval in several jurisdictions
SARA (Title III): Not listed as an extremely hazardous substance
California Proposition 65: No ingredients listed
Other Info: National inventories vary, check with local regulations prior to commercial use or transport