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Product Name: Valsartan
Chemical Formula: C24H29N5O3
Other Names: Diovan, N-(1-oxopentyl)-N-[[2'-(1H-tetrazol-5-yl)[1,1'-biphenyl]-4-yl]methyl]-L-valine
CAS Number: 137862-53-4
Intended Use: Pharmaceutical active ingredient for blood pressure control
Manufacturer Contact: Emergency phone numbers, company address, and responsible department details must be clearly listed on original packaging for urgent assistance.
Hazard Classification: Not classified as hazardous under normal laboratory conditions, but inhalation and contact can cause irritation or allergic reactions in some people.
Hazard Statements: May cause mild eye or skin irritation, ingestion of large amounts could affect blood pressure, no sufficient evidence for carcinogenicity from current data.
Precautionary Statements: Avoid contact with eyes, skin, and clothing. Do not breathe dust. Wash hands thoroughly after handling.
Signal Word: Warning
Pictograms: Not typically required based on current classification standards but precaution and simple PPE recommended in workplaces handling bulk powder or creating dust.
Chemical Name: Valsartan
Concentration: 100% (for pure API)
Impurities: Trace process-related impurities, none intended harmful if within pharmacopoeial limits.
Additives: No additives present in bulk active structure.
EC Number: Not available due to its pharmaceutical API status.
Inhalation: Move affected person outside to fresh air, keep comfortable for breathing, seek medical attention if breathing becomes difficult or irritation persists.
Skin Contact: Remove contaminated clothing, rinse skin thoroughly with water and mild soap, get medical attention if irritation or reaction develops.
Eye Contact: Rinse eyes cautiously with water for at least 10 minutes, separate eyelids. Remove contact lenses if present and easy to do, consult a physician if redness or pain continues.
Ingestion: Rinse mouth, drink water if conscious. Do not induce vomiting unless instructed by a professional. Get medical advice if large amount is swallowed or symptoms appear.
Most Important Symptoms: May include mild irritation, coughing, eye redness, dermatitis, possible low blood pressure if significant amount ingested.
Suitable Extinguishing Media: Use water spray, dry chemical, foam, or carbon dioxide.
Unsuitable Extinguishing Media: Direct water jets may spread fire, avoid without training.
Specific Hazards: May release toxic fumes including nitrogen oxides and carbon oxides when burning.
Advice for Firefighters: Wear full protective gear including self-contained breathing apparatus. Prevent runoff from entering drains. Stay upwind of fire area if possible.
Combustibility: Not highly flammable, but fine powder can present dust explosion risk under rare extreme conditions.
Personal Precautions: Use suitable personal protective equipment such as gloves, goggles, and dust mask or respirator. Avoid dust formation and inhalation.
Environmental Precautions: Prevent large volumes from entering soil, drains, or waterways.
Containment: Sweep up spills without creating dust. Place in a labeled, closed container for disposal.
Cleaning Methods: Wash after disposal with suitable detergent and water, ventilate area.
Emergency Measures: Alert trained personnel if spill is significant, and evacuate area if excessive airborne dust is present.
Handling: Avoid dust generation, handle in well-ventilated areas. Do not eat, drink, or smoke in work areas. Minimize exposure by using provided PPE.
Storage: Store in tightly closed containers in a cool, dry, well-ventilated facility, away from incompatible materials. Maintain temperature as specified by manufacturer (typically under 25°C).
Incompatible Materials: Strong oxidizing agents, moisture, strong acids.
Hygiene Measures: Wash hands thoroughly after handling and before eating. Maintain good industrial hygiene practices.
Exposure Limits: No established occupational exposure limits for valsartan but minimize dust levels following good laboratory practice.
Engineering Controls: Use local exhaust ventilation when handling powedered forms.
Personal Protective Equipment: Chemical-resistant gloves (nitrile or latex), safety glasses with side-shields, laboratory coat or suitable work clothing, dust mask or particulate respirator when powder is in use.
Environmental Controls: Prevent release of significant quantities into wastewater or soil by use of containment and careful disposal.
Appearance: White to off-white crystalline powder
Odor: Odorless
Melting Point: 105–110°C
Solubility: Practically insoluble in water, soluble in dimethylformamide and DMSO
pH: Not applicable (insoluble in water)
Boiling Point: Not available
Vapor Pressure: Negligible
Flash Point: Not applicable
Partition Coefficient (log Kow): Approx. 4.2
Density: Approx. 1.2 g/cm³
Chemical Stability: Stable under recommended storage and handling conditions.
Hazardous Reactions: None expected under normal conditions.
Materials to Avoid: Strong oxidizers, acids, and bases.
Hazardous Decomposition Products: Emits nitrogen oxides, carbon oxides, possibly toxic vapors if burned.
Conditions to Avoid: Excessive heat, formation of dust cloud, direct sunlight, moisture.
Acute Toxicity: Not acutely toxic via oral, dermal, or inhalation routes at typical occupational concentrations; LD50 (rat, oral) >2000 mg/kg.
Skin Corrosion/Irritation: May cause mild, transient irritation, not classified as a primary irritant.
Eye Damage/Irritation: Possible mild irritation, no permanent injury expected.
Respiratory Sensitization: Rare reports of allergy-related respiratory symptoms.
Chronic Toxicity: Chronic exposure data limited, long-term effects mainly related to pharmaceutical usage context (e.g., hypotension).
Carcinogenicity/Mutagenicity: No significant evidence found in animal studies.
Reproductive Toxicity: Should be avoided during pregnancy unless prescribed by healthcare provider.
Ecotoxicity: Not considered acutely hazardous to aquatic life at expected environmental concentrations, but may impact microorganisms and aquatic species in high doses.
Persistence and Degradability: Limited biodegradability data, likely to persist in strong chemical structure, slow breakdown in environment.
Bioaccumulative Potential: Log Kow suggests some potential for bioaccumulation but real-world data sparse.
Mobility in Soil: Low mobility due to poor water solubility, chemically binds to soil particles.
Other Adverse Effects: Risk to environment increases with improper large-scale disposal.
Waste Disposal Methods: Dispose of unused or excess in accordance with local regulations through licensed chemical waste contractor. Do not allow into sewers, surface or groundwater.
Contaminated Packaging: Empty containers must be triple rinsed, punctured, and disposed of or recycled as hazardous waste according to national regulations.
Special Precautions: Avoid direct contact with refuse handlers. Recommend incineration over landfill for significant quantities.
UN Number: Not regulated by road, air, or sea in most jurisdictions
Proper Shipping Name: Not classified as dangerous goods
Transport Hazard Class: None assigned
Packing Group: None
Special Precautions: Stored upright in sealed container, protected from humidity, accidental release, and rough handling during transport.
International Inventory Status: Not listed on global inventories such as TSCA or EINECS because of pharmaceutical use
Safety, Health and Environmental Regulations: Handled under strict pharmaceutical or medical standards, requires compliance with country-specific workplace, safety, and waste law.
Labeling Requirements: Hazard and identity labeling based on regional chemical standards must be used especially in bulk. SDS required in workplace under OSHA Hazard Communication Standard, EU CLP, and similar regulations
Other Regulatory Information: Controlled distribution, prescription required for therapeutic use, must meet GxP guidelines for manufacture, storage, handling, and transportation.
