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Material Safety Data Sheet for Inosine Pranobex

Identification

Product Name: Inosine Pranobex
Chemical Name: Isoprinosine (Inosine Acedoben Dimepranol)
Synonyms: Methisoprinol, Isoprinosine
CAS Number: 36703-88-5
Manufacturer: Indicated by specific supplier documentation
Recommended Use: Immunostimulant, antiviral pharmaceutical agent
Contact Details: Emergency phone number and postal address provided by supplier

Hazard Identification

Classification: Not classified as hazardous based on available information
Physical Hazards: None identified under normal conditions
Health Hazards: Possible irritation to eyes, skin, or respiratory tract with direct contact or inhalation of dust
Environmental Hazards: Avoid release to waterways and soil
GHS Pictograms: No specific symbols required
Signal Word: Not required

Composition / Information on Ingredients

Chemical Composition: Inosine, acedoben (p-acetamidobenzoic acid), dimepranol in defined stoichiometry
Active Substance: Inosine Pranobex (CAS: 36703-88-5), main component ~100% by weight
Impurities/Excipients: Not relevant except as process residues or residual solvents in trace amounts; detailed batch-level data available in batch records

First Aid Measures

Inhalation: Move person to fresh air, monitor for respiratory symptoms, seek medical attention if discomfort persists
Skin Contact: Wash thoroughly with soap and water, remove contaminated clothing, seek medical advice for irritation
Eye Contact: Rinse immediately with plenty of water for at least 15 minutes, keep eyelids open, seek medical attention if irritation remains
Ingestion: Rinse mouth, do not induce vomiting, seek medical evaluation promptly

Fire-Fighting Measures

Suitable Extinguishing Media: Dry chemical, CO2, foam, or water spray for larger volumes
Specific Hazards: Combustion may produce hazardous vapors including nitrogen oxides, carbon monoxide, and other organic decomposition products
Protective Equipment: Firefighter turnout gear, self-contained breathing apparatus
Advice for Firefighters: Contain run-off, avoid smoke inhalation, keep containers cool with water fog

Accidental Release Measures

Personal Precautions: Wear protective gloves, goggles, dust mask or respirator for significant spills
Environmental Precautions: Prevent further leakage or spillage, block product from entering drains or water courses
Cleanup Methods: Sweep or vacuum material, avoid dust formation, collect in labelled containers for disposal
Decontamination: Wash spill site with detergent solution after material removal

Handling and Storage

Handling: Work in well-ventilated areas, avoid generating dust, keep away from food and drink, use personal protective equipment
Storage: Store in tightly closed containers, dry and cool conditions below 25°C, protect from direct sunlight, segregate from incompatible substances including strong acids and oxidizers
Other precautions: Maintain good industrial and personal hygiene practices at all stages of handling

Exposure Controls and Personal Protection

Exposure Limits: Occupational exposure limits not set for this specific compound
Engineering Controls: Work under local exhaust ventilation, use closed systems where possible
PPE: Disposable gloves, safety glasses, protective clothing, NIOSH approved dust respirators for airborne particulates
Hygiene: Wash hands thoroughly after handling, remove and clean contaminated clothing before reuse

Physical and Chemical Properties

Appearance: White or almost white crystalline powder
Odor: Practically odorless
pH: Neutral (6.5–7.5 in aqueous solution)
Solubility: Soluble in water, low solubility in most organic solvents
Melting Point: 163–167°C
Boiling Point: Not applicable
Vapor Pressure: Negligible at room temperature
Other Data: Stable under normal handling conditions, non-volatile, non-explosive

Stability and Reactivity

Chemical Stability: Stable under recommended storage and handling conditions
Conditions to Avoid: Excess moisture, direct sunlight, excessive heat
Incompatible Materials: Strong acids, strong oxidizing agents
Decomposition Products: Heating can yield toxic gases such as nitrogen oxides, carbon oxides, and organic decomposition products
Polymerization: Not known to occur

Toxicological Information

Routes of Exposure: Inhalation, ingestion, skin and eye contact
Acute Toxicity: Low toxicity based on pharmaceutical use data, LD50 in rodents >2,000 mg/kg (oral)
Skin/Eye Irritation: May cause mild irritation
Respiratory Irritation: Dust can cause respiratory tract discomfort
Chronic Toxicity: No evidence of carcinogenicity or mutagenicity in animal models
Sensitization: Not expected to be a skin sensitizer
Other Effects: No data indicating reproductive toxicity at therapeutic doses

Ecological Information

Eco-toxicity: Low expected toxicity to aquatic and terrestrial life at environmentally relevant concentrations
Persistence and Degradability: Likely biodegradable under typical environmental conditions
Bioaccumulative Potential: Low potential for bioaccumulation
Mobility in Soil: Moderately mobile in the soil-water environment
Other Adverse Effects: Prevent large-scale releases, avoid product entering surface water, groundwater or soil

Disposal Considerations

Waste Disposal Methods: Dispose of material as pharmaceutical or chemical waste according to national and local regulations
Packaging Disposal: Clean containers before recycling or disposal, follow official instructions for hazardous waste transport
Special Precautions: Do not flush to drains or water systems, incineration may be appropriate under controlled conditions

Transport Information

UN Number: Not classified as dangerous for transport
Transport Hazard Class: Non-hazardous per IATA, IMDG, ADR standards
Packing Group: Not applicable
Labeling: No specific labeling required for ground, sea, or air transport
Special Provisions: Store and transport in closed, labelled containers away from incompatible substances and foodstuffs

Regulatory Information

International Regulation: Not listed by UN as hazardous; not subject to special environmental or health restrictions
OSHA Status: Not regulated as hazardous by OSHA standards in the United States
REACH Status: Not registered as a hazardous substance in the EU; reference to active pharmaceutical ingredient dossier
Other Regulations: Compliance with country-specific chemical safety, workplace exposure, and pharmaceutical safety rules required