Product Name: L-Phenylephrine bitartrate
Synonyms: Phenylephrine bitartrate, α-[(1R)-1-hydroxy-2-(methylamino)ethyl]benzene-methanol hydrogen tartrate
CAS Number: 61-76-7
Recommended Use: Active pharmaceutical ingredient, vasoconstrictor
Manufacturer/Supplier: Pharmaceutical manufacturers and chemical suppliers
Emergency Contact: Refer to local poison control center or chemical safety authority
GHS Classification: Eye irritation (Category 2A), Acute toxicity oral (Category 4), Specific target organ toxicity (single exposure, Category 3: respiratory tract)
Signal Word: Warning
Hazard Statements: Causes serious eye irritation. Harmful if swallowed. May cause respiratory irritation.
Pictogram: Exclamation mark symbol
Precautionary Statements: Avoid breathing dust. Wash hands thoroughly after handling. Use personal protective equipment as required.
Physical Hazards: No known significant hazards under normal handling. May cause upper respiratory tract, eye, or skin irritation through contact or dust inhalation.
Environmental Hazards: Avoid release into the environment.
Chemical Name: L-Phenylephrine bitartrate
Formula: C9H13NO2•C4H6O6
Concentration: 98-100% (pharmaceutical grade)
Impurities: Trace residual solvents, possible process-related residuals below regulatory thresholds
Other Components: This substance is present in pure form, no additives or excipients
Inhalation: Move exposed person to fresh air immediately. Provide oxygen or artificial respiration if breathing is difficult. Medical attention needed if symptoms persist.
Skin Contact: Remove contaminated clothing. Wash skin thoroughly with soap and water for at least 15 minutes. Seek medical aid for persistent irritation.
Eye Contact: Rinse eyes with water for several minutes, lifting upper and lower lids occasionally. Remove contact lenses if present and easy to do. Continue rinsing. Immediate examination by a healthcare provider advisable.
Ingestion: Rinse mouth thoroughly. Do not induce vomiting unless directed by medical personnel. Seek medical attention without delay.
Acute Effects: Cough, shortness of breath, respiratory distress, skin or eye redness. Medical evaluation recommended for significant exposure.
Suitable Extinguishing Agents: Water spray, dry powder, foam, or carbon dioxide. Use means appropriate for surroundings.
Specific Hazards: Combustion may release carbon monoxide, carbon dioxide, nitrogen oxides, and toxic fumes.
Protective Equipment: Firefighters should use self-contained breathing apparatus and full turnout gear.
Precautions: Move containers from fire area if possible without risk. Prevent runoff from entering drains or waterways.
Explosion Data: No known explosive properties, though dust may form explosive mixtures in air at high concentrations.
Personal Precautions: Evacuate unnecessary personnel. Wear protective clothing, gloves, goggles, and dust respirator.
Environmental Precautions: Prevent product from entering sewers, surface waters, or soil.
Cleanup Methods: Dampen spilled material to minimize dust. Use non-sparking tools and collect in a sealed container for disposal. Thoroughly ventilate spill site.
Decontamination: Wash area with water and detergent to remove residues. Secure all waste material for proper handling and disposal according to regulations.
Reporting: Local regulatory requirements may require notification for significant releases to environment.
Precautions for Safe Handling: Avoid inhalation of dust, ingestion, or contact with skin and eyes. Use in a well-ventilated area. Wash hands thoroughly after use.
Safe Storage Conditions: Store at room temperature (15–25°C) in tightly closed, original containers. Protect from light and moisture.
Incompatible Materials: Avoid contact with strong oxidizing agents, strong bases, or acids.
Hygiene Requirements: No eating, drinking, or smoking in storage or handling areas. Remove contaminated clothing promptly and launder before reuse.
Engineering Controls: Maintain adequate ventilation and local exhaust as needed for routine operations.
Exposure Limits: No established OSHA, ACGIH, or NIOSH limits; handle as a hazardous pharmaceutical material.
Ventilation: Use local exhaust or general dilution ventilation to minimize dust exposure.
Respiratory Protection: NIOSH- or EN-certified organic dust respirator for powder handling.
Hand Protection: Chemical-resistant gloves suitable for pharmaceuticals (nitrile, latex).
Eye Protection: Safety goggles or face shield.
Skin Protection: Laboratory coat or coveralls and closed shoes.
Work Practices: Good industrial hygiene practices essential for safe operations.
Appearance: White or off-white crystalline powder
Odor: Odorless
pH: 3.5–5.0 (1% aqueous solution)
Melting Point: 167–170°C
Solubility: Soluble in water, slightly soluble in ethanol
Density: Approx. 1.3 g/cm³
Molecular Weight: 337.31 g/mol
Vapor Pressure: Not applicable
Boiling Point: Not determined (decomposes)
Other Properties: Stable under recommended storage conditions; sensitive to moisture and light.
Chemical Stability: Stable at room temperature and standard pressure under recommended conditions.
Conditions to Avoid: Extended exposure to heat, moisture, and light. High humidity may cause degradation.
Incompatible Materials: Strong oxidizing agents, strong bases, acids.
Hazardous Decomposition: Carbon oxides, nitrogen oxides, toxic fumes upon combustion.
Polymerization: Not known to occur.
Routes of Exposure: Inhalation, ingestion, skin contact, eye contact.
Acute Toxicity: LD50 (rat, oral): approx. 350 mg/kg. May cause nausea, headache, increased blood pressure, or palpitations.
Skin/Eye Irritation: Causes irritation to eyes, possible skin redness with prolonged exposure.
Chronic Effects: Long-term exposure may impact cardiovascular system, particularly in persons with pre-existing conditions.
Sensitization: Not a known sensitizer.
Carcinogenicity: Not classified as a carcinogen by IARC, NTP, or OSHA.
Reproductive Effects/Teratogenicity: No conclusive data, but caution advised during pregnancy.
Other Effects: Respiratory tract irritation, transient CNS effects possible with large doses.
Aquatic Toxicity: Low acute toxicity to aquatic organisms. Careful disposal required to prevent environmental contamination.
Persistence and Degradability: Expected to biodegrade over time, but potential exists for bioaccumulation in aquatic environments if released in significant quantities.
Soil Mobility: Moderate mobility in soil and water.
Bioaccumulative Potential: Data limited, no strong evidence for significant bioaccumulation.
Other Adverse Effects: Not expected to cause major long-term environmental harm at pharmaceutical levels.
Disposal Methods: Handle as hazardous pharmaceutical waste. Incinerate in approved waste facility. Avoid landfill or sewer disposal.
Container Handling: Triple-rinse containers before disposal or recycling. Ensure all residues are properly managed.
Legal Compliance: Dispose according to local, regional, and national regulations governing pharmaceutical chemicals.
Special Considerations: Notify authorities if large-scale environmental release occurs.
UN Number: Not classified as a dangerous good under most transport regulations.
Proper Shipping Name: L-Phenylephrine bitartrate (pharmaceutical chemical, not otherwise specified)
Transport Hazard Class: Not regulated
Packing Group: Not regulated
Labeling: No special transport labeling required for small-scale, non-bulk shipments.
Bulk Shipping: Follow site-specific, company- or carrier- established procedures for pharmaceutical intermediates.
Precautions: Protect from moisture and physical damage during transit; ensure upright, sealed packaging.
TSCA Status: Exempted by FDA in pharmaceuticals
EU Classification: Complies with REACH exemption for pharmaceuticals
OSHA Hazard Communication: Regulated as hazardous based on chemical irritation potential
WHMIS (Canada): Classified as D2B (toxic material causing other toxic effects)
FDA/EMA: Subject to drug approval regulation for use in medicines
Other Requirements: Maintain records per GMP and national drug safety regulations.
Worker Protection: Employers required by OSHA and EU-OSHA to train employees in handling pharmaceutical actives with recognized hazards.
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