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Product Name: Prednisolone
Chemical Name: 11β,17α,21-Trihydroxypregna-1,4-diene-3,20-dione
CAS Number: 50-24-8
Synonyms: Delta1-Cortisone, Metacortandralone, 1-Dehydrocortisone
Recommended Use: Pharmaceutical corticosteroid, anti-inflammatory agent
Supplier Details: Pharmaceutical manufacturers and laboratories, contact information varies with supplier
Emergency Phone Number: Local poison control center or manufacturer's emergency hotline
GHS Classification: Not classified as hazardous under GHS criteria for pharmaceutical preparations
Health Risks: May cause immunosuppression, endocrine disruption, increased blood sugar, skin or eye irritation, respiratory issues with dust or aerosol formation
Environmental Hazards: Shows persistence in water, potential risk to aquatic life if large quantities are released
Label Elements: Avoid contact with skin, eyes, and clothing; avoid inhalation; prevent environmental exposure
Signal Word: None
Hazard Statements: Overexposure can affect multiple organ systems, especially in chronic or repeated exposure
Precautionary Statements: Use proper personal protective equipment and engineering controls in laboratory and industrial environments
Chemical Composition: Prednisolone (active ingredient): concentration depends on formulation (often tablets, suspensions, injectables)
Inactive Ingredients: Corn starch, lactose, magnesium stearate, microcrystalline cellulose, povidone (vary by manufacturer)
Impurities: Manufacturing residuals may include trace solvents or related corticosteroid compounds
Molecular Formula: C21H28O5
Molecular Weight: 360.44 g/mol
Inhalation: Remove to fresh air, monitor for shortness of breath or respiratory symptoms, seek medical advice if symptoms persist
Skin Contact: Wash thoroughly with soap and water, remove contaminated clothing, obtain medical attention for irritation or reactions
Eye Contact: Flush eyes for 15 minutes under running water, seek immediate medical evaluation
Ingestion: Rinse mouth, do not induce vomiting, consult a physician or poison control center for advice
Notes to Physician: Treat symptomatically, monitor electrolyte balance, blood glucose, and adrenal function if significant exposure suspected
Suitable Extinguishing Media: Water spray, carbon dioxide, dry chemical powder, foam
Specific Hazards: Product can produce hazardous combustion products including carbon oxides, irritating or toxic gases
Special Protective Equipment: Firefighters should use full protective gear and self-contained breathing apparatus
Fire Fighting Procedures: Control and contain runoff, avoid inhalation of combustion products, ventilate area after extinguishing
Spill or Leak Procedures: Wear personal protective equipment, avoid dust generation and dispersal, collect spilled material in suitable, sealed containers for disposal
Cleaning Methods: Use damp disposable towel or HEPA vacuum, avoid dry sweeping, minimize release to environment
Environmental Precautions: Prevent spill entry to waterways, sewers, soil
Personal Precautions: Remove unnecessary personnel, use respiratory protection if dust forms in enclosed space
Handling: Handle in ventilated areas, use personal protective equipment including gloves and eye protection, minimize aerosol or dust formation, avoid ingestion and skin contact
Storage: Store in tightly closed containers, away from light, in cool, dry, and well-ventilated environments, segregate from incompatible substances (strong acids, oxidizers)
Incompatibilities: Avoid contact with acids, bases, and oxidizing agents
Hygiene Requirements: Wash hands thoroughly after handling, avoid eating, drinking, or smoking in work area
Engineering Controls: Use local exhaust ventilation, containment devices for weighing and mixing
Respiratory Protection: Use NIOSH-approved respirator if dust or aerosols may be generated above exposure limits
Eye Protection: Safety glasses or goggles
Skin Protection: Lab coats, protective gloves, impervious footwear if risk of contamination
Work/Hygienic Practices: Change out of contaminated clothing, clean work surfaces regularly, monitor exposure levels for workers
Occupational Exposure Limit: Not established specifically for prednisolone, handle as potential occupational hazard
Appearance: White to off-white crystalline powder
Odor: Odorless
pH: 6.0-8.0 (aqueous suspension)
Melting Point/Freezing Point: 238–243°C
Boiling Point: Decomposes before boiling
Solubility: Practically insoluble in water, slightly soluble in methanol, ethanol, chloroform
Vapor Pressure: Negligible at ambient temperature
Density: 1.29 g/cm³ at 20°C
Partition Coefficient (log Kow): 1.8–2.5
Chemical Stability: Stable under normal temperature and pressure, light-sensitive, decomposes with prolonged exposure to elevated temperatures
Reactivity: Not reactive with most common materials, reacts with strong oxidizers
Thermal Decomposition: Releases carbon monoxide, carbon dioxide, potentially toxic fumes
Conditions to Avoid: Exposure to light, high temperatures, moisture
Hazardous Polymerization: Will not occur
Potential Acute Effects: May cause headache, dizziness, allergic skin reactions, shortness of breath if inhaled as dust or powder; gastrointestinal upset if ingested in significant amounts
Chronic Exposure: Prolonged or frequent exposure linked to adrenal suppression, Cushingoid symptoms, immunosuppression, hyperglycemia, osteoporosis, psychiatric disturbances
Carcinogenicity: Not classified as carcinogenic by IARC, NTP, or OSHA
Mutagenicity: No significant mutagenic potential observed in standard assays
Reproductive Effects: Possible fetal toxicity, avoid exposure during pregnancy
Routes of Exposure: Skin contact, inhalation, ingestion, eye contact
Environmental Fate: Not readily biodegradable, persistence in aquatic and terrestrial systems likely
Aquatic Toxicity: Low to moderate toxicity to fish, algae, aquatic invertebrates in concentrated form
Bioaccumulation: Potential for moderate bioaccumulation, especially in aquatic species
Mobility in Soil: Low, binds to sediments
Other Adverse Effects: Trace pharmaceutical residues in waterways may affect non-target organisms
Disposal Methods: Dispose of in compliance with federal, state, and local environmental regulations, incineration preferred for pharmaceutical waste
Container Disposal: Decontaminate and recycle or dispose of safely, do not discharge to surface drains
Precautions: Prevent environmental contamination, keep away from food, feed, and water sources, do not reuse empty containers
UN Number: Not classified as dangerous for transport
Proper Shipping Name: Prednisolone, or pharmaceutical product containing prednisolone
Transport Hazard Class: Not regulated as a hazardous material by DOT, IATA, IMDG
Packing Group: Not assigned
Marine Pollutant: Not applicable
Special Precautions: Protect from physical damage and direct sunlight during transport, prevent contamination of other goods
Regulatory Status: Prescription pharmaceutical regulated under national and international health authorities (FDA, EMA, Health Canada, others)
OSHA HazCom: Not classified as hazardous chemical under US OSHA 29 CFR 1910.1200
WHMIS (Canada): Exempt as prescription drug
TSCA Status: Not listed for non-research uses
REACH (EU): Pharmaceutical exemptions apply for registered medicinal products
Other Regulations: Handle in accordance with local occupational health and safety regulations and pharmaceutical waste guidance as set by local agencies
