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Product Name: Losartan Potassium
Chemical Formula: C22H22ClKN6O
CAS Number: 124750-99-8
Intended Use: Antihypertensive pharmaceutical ingredient
Supplier Details: Pharmaceutical manufacturers and distributors with established GMP certification
Emergency Contact: Refer to emergency phone number on supplied documentation
Synonyms: DuP 753, 2-Butyl-4-chloro-1-(p-o-tolylmethyl)imidazole-5-methanol monopotassium salt
Molecular Weight: 461.01 g/mol
GHS Classification: Not classified as hazardous according to GHS criteria under normal industrial use
Main Hazards: Possible respiratory irritation with inhalation, may cause skin or eye irritation, ingestion can result in gastrointestinal discomfort
Precautionary Statements: Avoid inhalation of dust, use proper protective equipment, prevent direct skin or eye contact
Signal Word: Warning
Hazard Pictograms: None designated for non-bulk pharmaceutical-grade material
Other Risks: Individuals with allergies or pulmonary sensitivity should only handle product with additional precautions
Chemical Name: Losartan Potassium
Concentration: Pure active ingredient
Impurities: May include trace solvent residues from manufacturing (identities and concentrations controlled by pharmacopeial standards)
Additives: None in API bulk; formulations may include lactose, starch, microcrystalline cellulose, magnesium stearate
Ingredient Disclosure: No known hazardous impurities at concentrations requiring disclosure
Safety Reference: Laboratory material safety data sheets available for excipients in pharmaceutical preparations
Inhalation: Move affected person to fresh air and keep at rest in a position comfortable for breathing; seek medical attention if symptoms persist
Skin Contact: Wash affected area thoroughly with soap and water; remove contaminated clothing and launder before re-use
Eye Contact: Rinse cautiously with water for several minutes; remove contact lenses if present and easy to do; continue rinsing; seek medical advice if irritation develops
Ingestion: Rinse mouth with water; do not induce vomiting unless directed by medical personnel; get medical advice/attention immediately if significant amount swallowed
Medical Attention: Advise healthcare providers regarding the nature of exposure; symptomatic treatment recommended
Suitable Extinguishing Media: Water spray, foam, dry chemical, or carbon dioxide
Unsuitable Media: Direct water jet may spread powder
Fire Hazards: Combustion can release toxic fumes including carbon monoxide, nitrogen oxides, chlorine compounds, potassium oxides
Protective Equipment: Firefighters should wear self-contained breathing apparatus and full protective clothing
Special Procedures: Control runoff water to minimize environmental impact; evacuate area if dust or decomposition fumes form
Explosion Data: Losartan potassium does not present a dust explosion hazard under normal handling conditions
Personal Protection: Wear nitrile gloves, safety goggles, lab coat, particulate respirator if dusting occurs
Environmental Precautions: Prevent entry into drains, water courses, or soil
Spill Cleanup: Gently sweep or vacuum material into suitable waste container avoiding dust generation; wash spill site with water/detergent
Disposal: Collect waste in accordance with local, regional, national, and international regulations
Additional Measures: Decontaminate surfaces thoroughly; dispose of contaminated PPE properly
Handling: Use only in well-ventilated areas; minimize dust generation and exposure; handle using established industrial hygiene practices
Storage Conditions: Store in a cool, dry, well-ventilated area away from incompatible materials; keep container tightly closed
Temperature Sensitivity: Avoid temperatures above 30°C; protect from freezing
Packing Materials: Use original packaging or containers made of compatible materials, such as HDPE
Incompatible Substances: Strong acids, oxidizing agents
Hygiene Practices: Wash hands thoroughly after handling; restrict access to authorized personnel only
Engineering Controls: Handle material under local exhaust ventilation; use HEPA-filtered enclosures for powder processing
OEL/TLV: Occupational exposure limit not established for losartan potassium; adopt exposure limits for similar active pharmaceutical ingredients when available
Personal Protective Equipment: Safety glasses or chemical goggles, lab coat, suitable gloves (nitrile preferred), dust mask (NIOSH-approved N95 or higher for powder handling), closed shoes
Respiratory Protection: Use approved respirator in situations with inadequate ventilation or high dust concentration
Environmental Controls: Minimize release to the environment with closed processes and proper waste collection
Special Precautions: Avoid contact with skin and eyes; do not eat, drink, or smoke during handling
Appearance: White to off-white crystalline powder
Odor: Odorless
Solubility: Slightly soluble in water; freely soluble in dimethylformamide (DMF), DMSO, and methanol
Melting Point: Decomposes above 260°C
Boiling Point: Not applicable (decomposes before boiling)
pH (1% solution): 10–12
Partition Coefficient (logP): 0.7–1.5
Vapor Pressure: Not significant at ambient temperature
Density: Not determined
Physical State: Solid at room temperature
Chemical Stability: Stable under recommended storage conditions
Conditions to Avoid: Exposure to moisture, high temperature, and incompatible chemicals can lead to degradation
Incompatible Materials: Strong acids, strong oxidants
Decomposition Products: Carbon monoxide, nitrogen oxides, hydrogen chloride, potassium oxides on thermal decomposition
Hazardous Reactions: No dangerous polymerization or hazardous reactions under normal processing and storage
Storage Recommendations: Use desiccant in packaging to prevent moisture absorption
Acute Toxicity: Oral LD50 (rat) > 3000 mg/kg—low acute toxicity
Potential Health Effects: Ingestion may cause headache, dizziness, hypotension, gastrointestinal irritation; inhalation may irritate upper respiratory tract; direct skin and eye contact can cause irritation or redness
Chronic Effects: Long-term effects not reported in occupational settings; classified as non-carcinogenic based on animal studies
Mutagenicity: Negative in standard in vitro and in vivo bacterial and mammalian assays
Teratogenicity: Developmental toxicity observed in some animal models at high doses
Sensitization: Not a known sensitizer
Medical Conditions Aggravated by Exposure: Individuals with hypersensitivity to sartans may show allergic reactions
Ecotoxicity: Data limited; no significant bioaccumulation predicted; aquatic toxicity low to moderate based on class
Persistence and Degradability: Partial biodegradation expected in sewage/water treatment
Mobility in Soil: Limited mobility due to low water solubility
Bioaccumulation Potential: Low based on partition coefficient
Other Adverse Effects: Pharmaceutical residues can contribute to long-term aquatic toxicity; apply best practices for waste control
Aquatic Precautions: Avoid discharge into natural watercourses, inform local authorities if significant release occurs
Waste Treatment Methods: Incinerate in approved facility; do not discharge into sewers or environment
Container Disposal: Triple rinse containers and offer for reconditioning or puncture and dispose in accordance with local regulations
Regulatory Status: Waste should be treated as hazardous under local disposal laws for pharmaceutical or chemical waste
Special Instructions: Consult with a licensed waste disposal company for large quantities or bulk APIs
Environmental Considerations: Prevent bulk quantities from reaching soil, waterways, or municipal waste without treatment
UN Number: Not regulated as dangerous goods under UN recommendations
Proper Shipping Name: Losartan Potassium, bulk pharmaceutical material
Transport Hazard Class: Not hazardous for air, road, rail, or sea freight per ADR, IMDG, IATA
Packing Group: None assigned
Special Precautions: Ship in sealed, labeled containers; keep away from incompatible materials and moisture
Labeling: Clearly state contents and emergency contacts on shipping cartons
International Regulations: Losartan Potassium quality and safety regulated by pharmacopeial standards (USP, EP, JP)
OSHA Status: Not specifically regulated as hazardous under OSHA standards; general chemical safety applies
TSCA Inventory: Not listed for commercial chemical use (pharmaceutical only)
REACH Registration: Exempt as medicinal product API
WHMIS Classification: Not controlled under Canada’s WHMIS
Other Regulatory Notes: Finished formulations registered per country-specific health authority requirements; local regulations for worker exposure and waste management apply
Label Requirements: Proper identification including hazard and precaution statements as guided by workplace safety legislation
