Product Name: Budesonide
Chemical Name: 16α,17-(Butylidenebis(oxy))-11β,21-dihydroxypregna-1,4-diene-3,20-dione
Synonyms: Pulmicort, Entocort, Budecort
CAS Number: 51333-22-3
Molecular Formula: C25H34O6
Molecular Weight: 430.54 g/mol
Manufacturer: Refer to product label
Recommended Use: Pharmaceutical corticosteroid, anti-inflammatory treatments (inhalation, oral, nasal formulations)
Emergency Overview: White to off-white crystalline powder, not highly flammable, not explosive under standard conditions
GHS Classification: Reproductive toxicity (Category 2), Specific target organ toxicity - repeated exposure (Category 2)
Label Elements: Warning symbol, Hazard statements: Suspected of damaging fertility or the unborn child. May cause damage to organs through prolonged or repeated exposure.
Routes of Exposure: Inhalation, ingestion, dermal contact
Target Organs: Liver, adrenal glands, reproductive organs
Acute Health Effects: Irritation of mucous membranes, dizziness, headache, nausea
Chronic Health Effects: Long-term suppression of the adrenal axis, possible teratogenic effects, immunosuppression possible
Environmental Hazards: May be hazardous to aquatic environments with long-term persistence; do not allow into water courses
Budesonide: 98%–100%
Impurities: Less than 2%, typically related corticosteroids
Excipients: None in raw material
Additives: None in API form
Inhalation: Move person to fresh air, keep comfortable, seek medical attention for symptoms
Ingestion: Rinse mouth thoroughly, do not induce vomiting, consult physician immediately
Skin Contact: Wash with soap and water for several minutes, remove contaminated clothing, seek attention for irritation
Eye Contact: Flush eyes with plenty of water for several minutes, consult ophthalmologist for eye irritation
Medical Attention Notes: Symptom-driven treatment recommended, monitor for adrenal suppression, supportive care as needed
Extinguishing Media: Use dry chemical, carbon dioxide, or water spray
Unsuitable Media: Avoid high-pressure water streams that may spread powder
Special Hazards: Decomposition products include carbon monoxide, carbon dioxide, and potentially hazardous oxides
Protective Equipment: Firefighters wear full protective gear and self-contained breathing apparatus
Explosion Data: Dust can form explosive mixtures with air at high concentrations; avoid creating dust clouds during large spills or fires
Personal Precautions: Wear gloves, lab coat, goggles, dust mask or respirator as needed
Environmental Precautions: Prevent powder drainage into water systems and sewers; contain spill
Spill Response: Sweep up carefully without generating dust, place into labeled container for disposal, ventilate area
Decontamination: Wash affected surfaces with detergent after removal of bulk material
Handling: Avoid contact with skin, eyes, and clothing. Use local exhaust ventilation. Handle in accordance with good laboratory practices. Avoid producing dust.
Storage: Store in tightly closed container. Recommended temperature is 2–8°C. Protect from excessive moisture, heat, and direct sunlight. Secure storage away from incompatible substances such as strong oxidizing agents.
Engineering Controls: Employ local exhaust and enclosure systems for weighing or transferring powder
Threshold Limit Values: Occupational exposure limits not established, but control workplace exposure below 0.05 mg/m³ as per pharmaceutical industry guidance
Personal Protective Equipment: Nitrile gloves, chemical splash goggles, disposable lab coat, and odour-filtering respirator if dust risk
Hygiene Measures: Wash hands thoroughly after handling, remove protective equipment before eating or leaving work area
Appearance: White to off-white crystalline powder
Odor: Practically odorless
pH: Not applicable (insoluble in water)
Melting Point: 224–231°C
Solubility: Freely soluble in chloroform and methanol, sparingly soluble in ethanol, practically insoluble in water
Partition Coefficient (log Kow): Approximately 2.2
Vapor Pressure: Negligible at 25°C
Boiling Point: Not available (decomposes before boiling)
Flash Point: Not established
Density: Around 1.3 g/cm³
Stability: Stable under recommended storage conditions with low reactivity at room temperature
Chemical Stability: Stable under normal temperatures and pressures, sensitive to moisture and light
Conditions to Avoid: High humidity, intense light, high temperatures, open flame
Incompatible Materials: Strong oxidizers, reducing agents, acids, alkalis
Hazardous Decomposition Products: Carbon dioxide, carbon monoxide, oxides of carbon
Polymerization: Does not occur under normal processing
Acute Toxicity: Oral LD50 (rat) greater than 2000 mg/kg, indicating low acute toxicity
Routes of Exposure: Inhalation, oral, dermal, ocular
Symptoms of Exposure: Headache, dizziness, dry throat, coughing, gastrointestinal discomfort, skin or eye irritation
Chronic Toxicity: Repeated exposure may lead to adrenal suppression, immunosuppression, growth retardation (children), possible reproductive effects
Carcinogenicity: No clear human evidence, limited animal studies show no direct carcinogenicity
Mutagenicity: Negative in most standard assays
Reproductive/Developmental Toxicity: Animal studies suggest possible teratogenic effects at high doses
Sensitization: Not a known skin sensitizer
Ecotoxicity: Harmful to aquatic life at high concentrations, especially chronic toxicity to algae and daphnia
Persistence and Degradability: Moderately persistent, breakdown in water may take weeks
Bioaccumulative Potential: Moderate due to lipophilicity (log Kow ~2.2)
Mobility in Soil: Weakly mobile; strong binding to organic matter
Other Adverse Effects: Avoid release to environment, small amounts can accumulate in sediments
Waste Disposal: Handle as hazardous pharmaceutical waste; collect in sealed containers
Treatment Methods: Incinerate at approved facility. Do not dispose of in local wastewater systems.
Container Disposal: Decontaminate containers prior to recycling or discarding
Regulatory Considerations: Follow local, regional, and national pharmaceutical waste regulations
UN Number: Not regulated for transport under UN Model Regulations
Proper Shipping Name: Not classified as dangerous goods for ADR, IATA, IMDG
Transport Hazard Class: Not assigned for road, rail, sea, or air
Packing Group: Not applicable
Special Precautions: Avoid mechanical shock and moisture exposure during shipment
Environmental Hazards: Not environmentally hazardous for transport purposes
Bulk Transport: Not regulated in bulk under Annex II of MARPOL73/78 and IBC Code
EU Regulations: Not classified as dangerous under Regulation (EC) No 1272/2008. Requires safety data sheet as per REACH.
US Regulations: Not listed as hazardous on SARA Title III or CERCLA. Subject to regulation as a pharmaceutical.
Canadian WHMIS: Controlled product category D2A (very toxic - other effects)
TSCA: Not listed
Other: Ensure compliance with relevant state, national, and local control laws concerning pharmaceutical ingredients.
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