Product Name: Phenylephrine Bitartrate
Chemical Name: (R)-1-(3-Hydroxyphenyl)-2-methylaminoethanol bitartrate
Synonyms: Phenylephrine Hydroxyamphetamine bitartrate, m-Hydroxyephedrine bitartrate
CAS Number: 61-76-7
Recommended Use: Pharmaceutical ingredient; decongestant
Manufacturer: Refer to supplier’s contact details on shipment paperwork
Emergency Contact: Local health authority, poison control center, workplace safety officer
UN Number: Not classified under UN dangerous goods
Molecular Formula: C9H13NO2·C4H6O6
Molecular Weight: 345.33 g/mol
GHS Classification: Eye irritation (Category 2A), Acute toxicity oral (Category 4), Skin irritation (Category 2)
Signal Word: Warning
Hazard Statements: Harmful if swallowed, causes serious eye irritation, can cause skin irritation.
Pictograms: Exclamation mark
Precautionary Statements: Wash exposed body parts after handling, wear protective gloves/eye protection, avoid breathing dust or vapor, do not eat, drink or smoke when using.
Potential Health Effects: May affect cardiovascular system, mucous membranes, and central nervous system with excessive exposure.
Other Hazards: Dust may form explosive mixtures in air under certain circumstances.
Chemical: Phenylephrine bitartrate
Concentration: 98-100%
Impurities: Negligible, pharmaceutical-grade material
CAS Number: 61-76-7
EINECS Number: 200-517-3
Relevant Components: No hazardous impurities present above cutoff
Inhalation: Move to fresh air, seek medical attention if symptoms persist, provide artificial respiration if required.
Skin Contact: Remove contaminated clothing, rinse skin with soap and water for at least 15 minutes.
Eye Contact: Rinse cautiously with water for several minutes, remove contact lenses if present and easy to do, continue rinsing. Seek medical attention.
Ingestion: Rinse mouth thoroughly, do not induce vomiting, seek immediate medical assistance.
General Advice: Consult a physician, show safety data sheet to doctor, ensure access to eyewash stations and safety showers in workplace.
Suitable Extinguishing Media: Use water spray, dry chemical, foam, or carbon dioxide.
Specific Hazards: May emit toxic fumes of nitrogen oxides, carbon monoxide, and carbon dioxide under combustion.
Protective Equipment: Firefighters wear self-contained breathing apparatus and full protective gear.
Precautions: Avoid breathing combustion products, control runoff to prevent environmental contamination.
Advice for Firefighters: Keep containers cool with water spray. Evacuate area as needed.
Personal Precautions: Avoid dust formation, use personal protective equipment including gloves, goggles, and lab coat.
Environmental Precautions: Prevent further leakage or spillage if safe to do so, avoid discharge to environment and water sources.
Methods for Clean-up: Sweep up without raising dust, place in suitable closed containers for disposal.
Clean-Up Procedures: Rinse area with detergent solution and ventilate.
Reference to Other Sections: Refer to exposure controls and disposal sections.
Handling: Use in well-ventilated areas, minimize dust generation, avoid contact with skin, eyes, and clothing, do not ingest or inhale.
Storage: Store in tightly closed containers, keep in a cool, dry, well-ventilated area, keep away from sources of ignition, incompatible substances (oxidizers), and out of reach of unauthorized personnel.
Incompatibilities: Strong oxidizing agents.
Handling Precautions: Use appropriate exhaust ventilation and mechanical handling to minimize exposures.
Exposure Limits: No established occupational exposure limits for this compound; handle with care.
Engineering Controls: Use local exhaust ventilation and containment methods.
Eye Protection: Chemical safety goggles.
Skin Protection: Nitrile gloves, protective lab coat.
Respiratory Protection: NIOSH/MSHA-approved respirator for nuisance dusts when adequate ventilation not available.
Hygiene Measures: Wash hands before breaks and after use, remove contaminated clothing.
Appearance: White to almost white crystalline powder
Odor: Odorless
Odor Threshold: Not available
pH: 3.5-5.5 (1% aqueous solution)
Melting Point/Freezing Point: 168-170°C (decomposes)
Boiling Point: Not applicable (decomposes before boiling)
Flash Point: Not available
Evaporation Rate: Not available
Flammability: No data
Upper/Lower Explosive Limits: Not determined
Vapor Pressure: Negligible
Vapor Density: Not applicable
Relative Density: 1.3 g/cm³
Solubility: Very soluble in water (approx. 200 mg/mL); sparingly soluble in alcohol; practically insoluble in ether
Partition Coefficient: logP: -0.1 (estimated)
Auto-ignition Temperature: Not determined
Decomposition Temperature: >160°C
Viscosity: Not applicable
Chemical Stability: Stable under recommended storage conditions.
Reactivity: No hazardous reactivity expected under normal conditions.
Conditions to Avoid: Excessive heat, sources of ignition, moisture.
Incompatible Materials: Oxidizing agents, strong acids or bases.
Hazardous Decomposition Products: Carbon monoxide, carbon dioxide, nitrogen oxides.
Polymerization: Will not occur.
Acute Toxicity: Oral LD50 (rat): 350 mg/kg (approximate); significant toxicity possible with ingestion in humans.
Skin Corrosion/Irritation: Can cause irritation upon prolonged contact.
Serious Eye Damage/Irritation: May cause severe irritation, redness, and blurred vision.
Respiratory Sensitization: May cause irritation of respiratory tract if inhaled.
Germ Cell Mutagenicity: No data available.
Carcinogenicity: Not listed by IARC, NTP, or OSHA as a carcinogen.
Reproductive Toxicity: No data available on adverse effects in humans.
Specific Target Organ Toxicity: May affect cardiovascular and central nervous systems at high doses.
Aspiration Hazard: Not classifiable.
Other Effects: Drowsiness, headache, palpitations, or hypertension with high or prolonged exposure.
Aquatic Toxicity: May be harmful to aquatic organisms; data limited.
Persistence and Degradability: Not readily biodegradable; may persist in environment.
Bioaccumulative Potential: Low potential based on physico-chemical properties.
Mobility in Soil: Water soluble, likely to be mobile in aqueous environments.
Other Adverse Effects: Avoid release into environment to minimize potential risk.
Waste Disposal Methods: Dispose of as hazardous pharmaceutical waste in accordance with local, regional, and national regulations.
Contaminated Packaging: Clean and dispose of packaging as chemical waste.
Special Precautions: Incineration recommended for large quantities, prevent release to sewers and surface waters.
Disposal Recommendations: Consult licensed professional waste disposal service to handle material.
UN Number: Not regulated as hazardous material for transportation by land, air, or sea.
Proper Shipping Name: Phenylephrine bitartrate (non-hazardous for purposes of transport).
Transport Hazard Class: Not classified.
Packing Group: Not classified.
Environmental Hazards: Not marine pollutant.
Special Precautions for User: Secure packaging to prevent movement or damage.
Safety, Health and Environmental Regulations: OSHA: Not specifically regulated; TSCA: Listed; SARA Title III: Not listed.
Labeling Requirements: Follows GHS labeling and communication standards.
Other Regulations: Complies with FDA regulations for pharmaceutical raw materials, REACH registration not applicable for active pharmaceutical ingredients produced or imported below threshold quantities.
Restrictions: Subject to prescription use and controlled dispensing depending on jurisdiction.
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