Product Name: Vinorelbine Bitartrate
Chemical Formula: C45H54N4O8 • C4H6O6
Synonyms: Navelbine, Vinorelbinum, VNB
CAS Number: 125317-39-7
Manufacturer: Pharmaceutical manufacturer name and address
Recommended Use: Cytotoxic anti-cancer agent for injection or intravenous therapy
Emergency Contact: Emergency telephone number of the manufacturer or supplier
GHS Classification: Acute Toxicity (Oral, Dermal, Inhalation) - Category 3, Carcinogenicity - Category 2, Mutagenicity - Category 2, Reproductive Toxicity - Category 2
Signal Word: Danger
Hazard Statements: May cause cancer, may damage fertility or the unborn child, toxic if swallowed, in contact with skin, or if inhaled, suspected of causing genetic defects, causes serious eye irritation
Pictograms: Skull and crossbones, Health hazard, Exclamation mark
Precautionary Statements: Avoid contact with skin and eyes, wear protective gloves and clothing, contain and avoid release into environment, avoid breathing dust or vapor
Chemical: Vinorelbine Bitartrate
Concentration: >95% (active ingredient)
Molecular Weight: 867.0 g/mol (base), bitartrate form increases MW
Impurities: May contain small amounts of related vinca alkaloids or synthetic byproducts
Other Constituents: Trace excipients depending on formulation, may include sodium chloride, water for injection for liquid forms
Inhalation: Move affected person to fresh air, provide artificial respiration if breathing has stopped, seek immediate medical attention
Skin Contact: Remove contaminated clothing, wash skin thoroughly with plenty of water and soap, do not reuse contaminated clothing, get medical help if irritation or redness occurs
Eye Contact: Rinse cautiously with water for several minutes, remove contact lenses if present and easy to do, continue rinsing, obtain medical attention
Ingestion: Rinse mouth with water, do not induce vomiting, never give anything by mouth to an unconscious person, seek urgent medical advice
Most Important Symptoms: May cause irritation, neurological symptoms, gastrointestinal distress, cytotoxic effects, risk of myelosuppression, immunosuppression, secondary infections
Suitable Extinguishing Media: Use carbon dioxide, dry chemical powder, water spray, or foam for surrounding fire
Unsuitable Extinguishing Media: Avoid high-pressure water jet
Hazardous Decomposition: Emits acrid smoke, nitrogen oxides, carbon monoxide, and toxic fumes on combustion
Fire-Fighting Procedures: Firefighters must wear full protective gear and self-contained breathing apparatus, avoid breathing combustion products, keep upwind of fire, use water spray to cool containers
Explosion Risk: Not known to present explosion risk under normal conditions, but containers may burst in heat
Personal Precautions: Evacuate non-essential personnel, restrict access to spill area, avoid inhalation or skin contact, use appropriate personal protective equipment
Environmental Precautions: Prevent further leakage or spillage if safe, do not allow to enter drains, watercourses, or soil, report releases to environmental authorities if required
Cleanup Methods: Absorb with inert material like sand or vermiculite, collect using tools that minimize dust, place in labeled, sealed containers for disposal as hazardous waste
Decontamination: Wash spill area thoroughly with detergent and water
Emergency Procedures: Notify appropriate authorities if exposure occurs in a public area
Handling: Handle as a cytotoxic drug with care, avoid splashing, formation of aerosols, direct contact with skin and eyes, use engineering controls like fume hoods or glove boxes when preparing solutions, avoid eating, drinking, or smoking near handling areas, wash hands thoroughly after handling
Storage: Store in tightly closed containers away from incompatible materials, maintain at temperatures recommended by manufacturer (usually 2-8°C for injection solutions), protect from light and humidity, keep away from unauthorized personnel
Incompatible Materials: Strong oxidizers, acids, and bases
Special Restrictions: Restrict access to trained personnel only
Exposure Limits: No occupational exposure limits established by OSHA, NIOSH, ACGIH; employers rely on best practices for cytotoxic agents
Engineering Controls: Use of certified chemical fume hoods, closed system transfer devices, negative pressure rooms for compounding, separate proper waste containers for cytotoxic spills and wastes
Personal Protective Equipment: Lab coat, impervious gloves (preferably double-gloving with nitrile), safety goggles or face shield, respiratory protection if risk of inhalation, chemical-resistant apron or gown for handling large volumes
Special Precaution: Dispose of gloves and disposable equipment in designated cytotoxic waste bins, avoid reuse
Appearance: White or off-white crystalline powder
Odor: Odorless or characteristic faint chemical odor
Boiling Point: Not applicable (decomposes before boiling)
Melting Point: 208–210°C (decomposition)
Solubility: Soluble in water, sparingly soluble in ethanol and methanol, practically insoluble in ether and chloroform
pH: 3.0–5.0 (1% aqueous solution)
Partition Coefficient (log P): -0.4 (estimated)
Vapor Pressure: Not significant at room temperature
Flash Point: Not applicable
Density: Not determined due to the nature of the material used primarily as an injectable drug
Chemical Stability: Stable under recommended storage conditions, sensitive to prolonged exposure to light, heat, or humidity
Reactivity: Not reactive with most pharmaceuticals, but incompatible with strong oxidizing agents, acids, and bases
Hazardous Reactions: No dangerous polymerization or hazardous reactions under normal handling
Decomposition Products: Toxic gases including carbon monoxide, carbon dioxide, nitrogen oxides under fire conditions
Conditions to Avoid: Avoid excessive heat, exposure to direct sunlight, strong acids or bases, and moisture
Routes of Exposure: Inhalation, skin, eye, ingestion
Acute Toxicity: Highly toxic by all routes, human therapeutic doses as low as 25 mg/m² can cause severe adverse effects
Chronic Toxicity: Bone marrow suppression, peripheral neurotoxicity, gastrointestinal effects, risk of secondary cancers with long-term exposure
Carcinogenicity: Animal studies suggest possible carcinogenicity, classified as Category 2 by GHS
Mutagenicity: Evidence of genotoxicity in preclinical assays
Reproductive Toxicity: Fetal damage evidenced in animal studies, embryotoxic and teratogenic effects expected
Symptoms of Exposure: Nausea, vomiting, weakness, hair loss, oral ulceration, hematologic suppression, infection
Aquatic Toxicity: Highly toxic to aquatic organisms, particularly fish and invertebrates, even at low concentrations
Persistence and Degradability: Low biodegradability, expected to persist in the environment
Bioaccumulation: Not expected to bioaccumulate significantly due to high polarity and low log P
Mobility in Soil: Moderate to high mobility in water, may reach groundwater if released
Other Impacts: Cytotoxic effects pose a hazard to sewage treatment plant microorganisms, risk of ecosystem disruption with improper disposal
Disposal Methods: Treat as hazardous pharmaceutical waste, incineration is recommended in approved facilities, do not dispose of down the drain
Container Disposal: Empty containers must be triple rinsed and rinsate disposed as hazardous waste, render containers unusable before disposal
Precautions for Disposal: Personnel must wear protection during handling of waste, follow institutional or regulatory protocols for cytostatic medications
Additional Information: Do not attempt to neutralize or treat waste in general landfill or through sewage systems
UN Number: UN 1851
Proper Shipping Name: Medicinal product, toxic, n.o.s. (contains Vinorelbine Bitartrate)
Transport Hazard Class: 6.1 (Toxic substances)
Packing Group: II
Label: Toxic
Special Precautions: Use leak-proof, chemical-resistant, and clearly labeled containers, ensure documentation accompanies shipments, emergency response guidelines must be provided
Regulatory Notes: Comply with DOT, ADR, IMDG, and IATA rules for regulated toxics
Regulatory Classification: Controlled as a hazardous, cytostatic drug in many countries, subject to pharmaceutical regulatory oversight
CAS Reporting Requirements: Subject to reporting by manufacturers, importers, and distributors
OSHA Status: Classified as a hazardous drug, listed under NIOSH hazardous drug recommendations
SARA Title III: Not listed as extremely hazardous, but subject to workplace safety planning
International Regulations: Complies with EU REACH, CLP, GHS, and national occupational safety standards (such as WHMIS in Canada)
Safety Precautions: Facilities dispensing or compounding the drug implement hazardous drug exposure control plans
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