Material Safety Data Sheet: Pentoxyverine Citrate

1. Identification

Product Name: Pentoxyverine Citrate
Chemical Formula: C20H29NO7 • C6H8O7
Synonyms: Pentoxyverine hydrogen citrate, Antitussive agent
Manufacturer: Refer to product supplier’s information
Recommended Use: Cough suppressant in pharmaceutical formulations
Emergency Telephone: Use local emergency contact information

2. Hazard Identification

Classification: Harmful if swallowed, irritant to eyes and respiratory system
Signal Word: Warning
Hazard Statements: Causes eye and respiratory irritation, harmful if ingested
Pictograms: Exclamation mark
Precautionary Statements: Avoid contact with skin and eyes, keep container closed, wash thoroughly after handling, use only in well-ventilated areas, avoid inhalation of dust or vapor

3. Composition / Information on Ingredients

Chemical Name: Pentoxyverine Citrate
Active Ingredient: Pentoxyverine Citrate
Concentration or Range: 98% or greater by weight
Impurities: Trace organics and inorganic salts (< 2%)
Additives: None
CAS Number: 8003-22-7 (Pentoxyverine Citrate)

4. First Aid Measures

Eye Contact: Rinse cautiously with water for several minutes, remove contact lenses if present, continue rinsing, seek medical attention if irritation persists
Skin Contact: Wash skin thoroughly with mild soap and water, remove contaminated clothing, seek medical help if rash or irritation occurs
Inhalation: Move victim to fresh air, keep warm and at rest, administer oxygen if breathing is difficult, call a physician
Ingestion: Rinse mouth thoroughly, do not induce vomiting, never give anything by mouth to an unconscious person, obtain medical attention immediately
Symptoms and Effects: Nausea, vomiting, dizziness, cough suppression, respiratory discomfort, may aggravate existing respiratory or allergic conditions

5. Fire-Fighting Measures

Suitable Extinguishing Media: Water spray, dry powder, foam, carbon dioxide
Unsuitable Extinguishing Media: High pressure water jets
Special Hazards Arising: May emit toxic fumes of carbon oxides and nitrogen oxides, dense smoke possible
Protective Equipment: Wear self-contained breathing apparatus and full protective gear
Special Procedures: Move containers from danger area if it can be done safely, avoid inhaling smoke or fumes

6. Accidental Release Measures

Personal Precautions: Ventilate area, avoid formation and inhalation of dust, wear protective gloves, goggles, and mask
Environmental Precautions: Prevent entry into drains, sewers, or watercourses, contain spill with absorbent material
Clean-Up Methods: Gather material into suitable closed containers, sweep or vacuum up spillage, wash site with soap and water after removal
Emergency Procedures: Notify management and follow established procedures for hazardous material spills

7. Handling and Storage

Handling: Use local exhaust ventilation in processing areas, avoid dust generation, do not breathe dust, keep container tightly closed after each use, use only with recommended personal protective measures
Storage: Store in original, sealed container in a cool, dry, well-ventilated area away from incompatible substances such as strong oxidizers and acids, protect from light, moisture, and physical damage, keep out of reach of children

8. Exposure Controls and Personal Protection

Occupational Exposure Limits: No established regulatory exposure limits; minimize exposure as a precaution
Control Parameters: Monitor air for potential dust concentrations
Personal Protection: Wear appropriate safety goggles, laboratory gloves, lab coat or apron, approved respirator if dust forms
Engineering Controls: General room ventilation, local exhaust as needed
Hygiene Measures: Wash thoroughly after handling, do not eat, drink, or smoke in areas where this chemical is handled, launder contaminated clothing before reuse

9. Physical and Chemical Properties

Appearance: White to off-white crystalline powder
Odor: Faint, characteristic odor
Odor Threshold: Not determined
pH: 4 to 6 (1% aqueous solution)
Melting Point/Freezing Point: 155–160 °C
Initial Boiling Point and Range: Not applicable (decomposes on heating)
Flash Point: Not identified
Evaporation Rate: Not relevant
Flammability: Not flammable under normal conditions
Vapor Pressure: Negligible at standard temperature
Vapor Density: Not available
Relative Density: 1.2 - 1.4 g/cm³
Solubility: Soluble in water, ethanol; insoluble in ether
Partition Coefficient (n-octanol/water): Not available
Auto-ignition Temperature: Not determined
Decomposition Temperature: Decomposes above melting point

10. Stability and Reactivity

Chemical Stability: Stable under recommended handling and storage conditions
Reactivity: No dangerous reactions known under normal use
Possible Hazardous Reactions: Contact with strong oxidizers or strong acids may cause decomposition
Conditions to Avoid: Moisture, excessive heat, exposure to light, incompatible materials
Incompatible Materials: Strong acids, strong bases, oxidizing agents
Hazardous Decomposition Products: Carbon monoxide, carbon dioxide, nitrogen oxides, irritating fumes

11. Toxicological Information

Acute Toxicity: LD50 (oral, rat): approximately 1000 mg/kg (literature value)
Routes of Exposure: Ingestion, inhalation, skin, and eye contact
Symptoms: May include coughing suppression, dizziness, headache, gastrointestinal upset
Skin Corrosion/Irritation: Mild irritant
Eye Damage/Irritation: May cause mild to moderate irritation
Respiratory Sensitization: May aggravate asthma or respiratory allergies
Carcinogenicity: No components identified as carcinogenic by IARC, NTP, or OSHA
Mutagenicity: Not identified as a mutagen in standard assays
Reproductive Toxicity: No known effects
Repeated Dose Toxicity: Data limited; avoid long-term exposure

12. Ecological Information

Ecotoxicity: Data limited, avoid release to the environment
Aquatic Toxicity: Harmful to aquatic organisms at high concentrations
Persistence and Degradability: Not readily biodegradable, may persist in environment
Bioaccumulative Potential: Expected to have low bioaccumulation potential
Mobility in Soil: Moderately mobile, may leach after heavy rainfall
Other Adverse Effects: Not known to produce endocrine disruption

13. Disposal Considerations

Appropriate Disposal: Dispose of as hazardous pharmaceutical waste in accordance with local, regional, or national regulations, do not incinerate in open air, avoid discharge to natural waters
Contaminated Packaging: Triple rinse containers, perforate and dispose via licensed chemical waste handler
Disposal Methods: Contact licensed waste disposal contractor, do not reuse contaminated packaging

14. Transport Information

UN Number: Not assigned
UN Proper Shipping Name: No data available for regulation under international transport authorities
Transport Hazard Class: Not classified as dangerous goods
Packing Group: Not applicable
Environmental Hazards: Not a marine pollutant
Special Precautions for User: Prevent spillage during transit, avoid contact with food and feedstuffs, secure containers appropriately

15. Regulatory Information

OSHA: Not classified as hazardous under US OSHA Hazard Communication Standard
TSCA: Not listed for use under TSCA
EU Regulations: Not subject to classification under CLP Regulation (EC) No 1272/2008, pharmaceutical use only
Other National Regulations: Subject to regulations under national pharmaceutical and chemical safety standards
Label Requirements: Pharmaceutical grade, for prescription or industrial use only, not for general public sale
Specific Provisions: Comply with applicable workplace safety and product stewardship requirements