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Chemical Name: Salmeterol Base
CAS Number: 89365-50-4
Synonyms: Salmeterol, (R)-Salmeterol
Recommended Use: Active pharmaceutical ingredient used in respiratory medicine
Manufacturer Information: Supplied by chemical manufacturers specializing in pharmaceutical-grade active ingredients; contact information available on batch or purchase documents
Emergency Contact: Refer to supplier’s 24-hour emergency assistance number; local poison control recommended for accidental human exposure
GHS Classification: Skin Sensitization (Category 1), Eye Irritation (Category 2), Specific Target Organ Toxicity – Repeated Exposure (Category 2)
Signal Word: Warning
Hazard Statements: Causes skin irritation. Causes eye irritation. May cause allergy or asthma symptoms or breathing difficulties if inhaled. May cause damage to organs through prolonged or repeated exposure.
Precautionary Statements: Wear protective gloves, clothing, and eye/face protection. Avoid breathing dust or powder. Use only outdoors or in a well-ventilated area. Avoid release to the environment without proper controls.
Pictograms: Exclamation mark, Health hazard
Substance: Single constituent
Chemical Identity: (R)-Salmeterol
Purity: Typically greater than 98% by chromatography
Impurities: Pharmaceutical standards require reporting of any impurity over 0.1%. Common process-related impurities may include related benzenic structures in trace amounts.
Molecular Formula: C25H37NO4
Molecular Weight: 415.57 g/mol
Inhalation: Move exposed person to fresh air. Keep patient still and warm. Seek medical attention if symptoms persist, especially any difficulty breathing.
Skin Contact: Remove contaminated clothing. Wash skin with soap and water for at least 15 minutes. Contact a physician if irritation persists.
Eye Contact: Rinse cautiously with water for several minutes. Remove contact lenses if present and easy to do. Continue rinsing. Seek immediate medical help if irritation develops or persists.
Ingestion: Rinse mouth thoroughly with water. Never induce vomiting unless directed by medical personnel. Seek medical attention if adverse symptoms are observed.
Suitable Extinguishing Media: Use water spray, foam, dry chemical, or carbon dioxide as appropriate.
Specific Hazards: Combustion may generate toxic fumes such as nitrogen oxides, carbon monoxide, and carbon dioxide.
Protective Equipment: Firefighters should wear self-contained breathing apparatus and full protective clothing.
Special Precautions: Prevent water runoff from fire-fighting from entering surface waterways and drains.
Personal Precautions: Wear respiratory protection, chemical-resistant gloves, laboratory coat, and goggles. Avoid inhalation of powder and contact with eyes or skin.
Environmental Precautions: Prevent further leakage or spillage. Do not let product enter drains or watercourses.
Cleanup Methods: Use a HEPA-filter vacuum or wet-dust methods to prevent dust generation. Collect spillage into labeled containers for disposal according to local regulations. Wash spill area with soapy water after material pickup.
Handling: Wear protective equipment to prevent exposure. Handle using powder-resistant procedures in a fume hood. Avoid raising dust or aerosol; maintain good industrial hygiene practices. Do not eat, drink, or smoke during handling.
Storage: Store in well-ventilated, cool, and dry area. Keep container tightly closed and away from incompatible substances such as strong oxidizers. Store away from light and moisture to maintain integrity.
Engineering Controls: Use local exhaust ventilation, laboratory hoods, or other process enclosures to control airborne levels.
Personal Protective Equipment: Respiratory protection (N95 mask or better), chemical-resistant gloves (such as nitrile), lab coat, and safety goggles. Eye wash stations and safety showers recommended in work area.
Occupational Exposure Limits: No official OSHA, NIOSH, or ACGIH limits established for salmeterol base; workplace controls should minimize exposure to as low as reasonably achievable.
Environmental Controls: Avoid release to the environment; maintain containment procedures during use and disposal.
Appearance: White to off-white crystalline powder
Odor: Faint or odorless
Odor Threshold: Not established
pH: Data not available; typically slightly alkaline solutions
Melting Point: 81–83°C
Boiling Point: Decomposes prior to boiling
Flash Point: Data not available
Evaporation Rate: Not applicable
Flammability: Not classified as flammable
Vapor Pressure: Negligible at ambient conditions
Vapor Density: Not applicable
Solubility: Soluble in methanol and ethanol; low water solubility
Partition Coefficient (n-octanol/water): LogP around 3.9
Autoignition Temperature: Not established
Decomposition Temperature: Above 150°C, releases toxic fumes
Viscosity: Not applicable to solids
Molecular Formula: C25H37NO4
Chemical Stability: Stable under recommended storage conditions away from strong oxidizers and reducing agents.
Reactivity: No dangerous reactions under normal use.
Conditions to Avoid: Elevated temperature, open flame, direct sunlight, and moisture.
Incompatible Materials: Strong oxidizers, acids, and bases.
Hazardous Decomposition Products: Carbon monoxide, carbon dioxide, nitrogen oxides, and volatile organic compounds upon combustion or decomposition.
Routes of Exposure: Inhalation, skin and eye contact, ingestion
Acute Effects: May irritate eyes, skin, and respiratory tract. Rare cases of skin sensitization. May cause symptoms of beta2-agonist overdose: tremor, palpitations, tachycardia if systemically absorbed in significant amounts.
Chronic Effects: Long-term overexposure can potentially cause cardiovascular and central nervous system effects; documented symptoms include irregular heartbeat and muscle cramps.
LD50/LC50: Specific animal data limited in literature, but rodent studies suggest moderate acute toxicity via oral and inhalational exposure.
Carcinogenicity: Not classified as carcinogenic by IARC, NTP, or OSHA.
Mutagenicity: Negative in available Ames test and in-vivo genotoxicity studies.
Reproductive Effects: Animal studies have not shown specific teratogenic or reproductive effects at typical exposure levels.
Ecotoxicity: Available data indicate moderate to low acute toxicity to aquatic organisms. Most studies show low environmental persistence or bioaccumulation.
Persistence and Degradability: Not readily biodegradable; slow breakdown expected in natural water and soils.
Bioaccumulative Potential: Based on LogP, potential for bioaccumulation exists, though low when diluted or dispersed.
Mobility in Soil: Highly bound to soil particles due to chemical structure, so limited mobility expected.
Other Adverse Effects: Avoid release to environment due to lack of comprehensive ecotoxicological data.
Waste Disposal: Follow all applicable federal, state, and local regulations for pharmaceutical waste. Incineration in a chemical incinerator equipped with afterburner and scrubber recommended.
Contaminated Packaging: Containers must be triple-rinsed and disposed of as hazardous pharmaceutical waste.
Precautions: Do not dispose with normal laboratory or domestic waste. Prevent residue from entering water supply or soil.
UN Number: Not assigned; not regulated as dangerous goods by ground, air, or sea under current international regulations
Proper Shipping Name: Salmeterol Base, solid, non-hazardous
Transport Hazard Class: Not classified as a hazardous substance
Packing Group: Not regulated
Environmental Hazards: Avoid accidental spillage in transit
Special Precautions: Ship in well-sealed containers, protect from physical damage and extreme humidity during transportation
US Regulations: Not specifically listed in SARA, CERCLA, RCRA as a hazardous substance; regulatory oversight by FDA for use as a pharmaceutical API. OSHA dust exposure standards apply in the workplace.
EU Regulations: Not classified under CLP as a dangerous substance at current data points for laboratory use. REACH preregistration possible if handling over one tonne per year.
Other Global Requirements: Manufacturers and importers must verify compliance with local environmental, workplace safety, and pharmaceutical regulations in recipient countries.
Inventory Status: Typically not listed on TSCA, EINECS, DSL, or AICS for non-commercial/industrial use.
Labeling: Appropriate hazard and precautionary labeling required on all commercial packaging.
