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Product Name: Methylprednisolone Acetate
Chemical Formula: C24H32O6
CAS Number: 53-36-1
Synonyms: Depo-Medrol, 6α-Methylprednisolone 21-acetate
Manufacturer: Multiple global pharmaceutical suppliers
Recommended Use: Pharmaceutical corticosteroid
Contact Information: Medical Affairs and Emergency Number provided by supplier
GHS Classification: Not classified as hazardous according to GHS criteria for pharmaceuticals
Signal Word: Not applicable for pharmaceutical use
Hazard Statements: May cause allergic reactions, risk of immunosuppression, potential for reproductive toxicity based on corticosteroid class
Precautionary Statements: Avoid ingestion, inhalation, and skin contact; practice safe lab hygiene
Routes of Exposure: Skin, inhalation, ingestion, eye contact
Symptoms: Allergic reactions, respiratory irritation, dizziness, changes in appetite
Chemical Name: Methylprednisolone Acetate
Concentration: Pharmaceutical grade, usually in sterile suspension (approx. 40mg/mL in commercial products)
Impurities/Additives: Formulations may include polyethylene glycol, sodium chloride, polysorbate 80, benzyl alcohol (depending on product)
Relevant Components: No significant excipients are considered hazardous under normal usage
Inhalation: Remove person to fresh air, consult medical professional if symptoms develop
Skin Contact: Wash area with soap and water, remove contaminated clothing, seek attention if irritation develops
Eye Contact: Rinse cautiously with water for several minutes, remove contact lenses if present, do not rub eyes
Ingestion: Rinse mouth, drink plenty of water, seek medical attention for accidental ingestion
Acute Symptoms: Shortness of breath, rash, swelling, severe headache, seek emergency medical aid in the event of severe symptoms
Suitable Extinguishing Media: Use dry powder, sand, carbon dioxide, or foam extinguishers for small fires
Special Hazards: Combustion can release carbon oxides and unfamiliar toxic fumes
Protective Equipment: Wear self-contained breathing apparatus and full protective gear
Advice for Firefighters: Prevent contaminated fire runoff from entering waterways, minimize exposure to fumes
Personal Precautions: Wear gloves, safety goggles, and a dust mask to limit exposure
Environmental Precautions: Avoid discharge to sewers and surface waters; collect spills with absorbent material
Cleanup Method: Scoop up with inert, non-combustible absorbents (e.g., sand, earth), place in a suitable container for disposal
Decontamination: Wash the spill area thoroughly with water following removal of material, ventilate space
Handling Precautions: Use proper lab techniques, avoid creating dust, employ PPE as appropriate
Safe Storage Conditions: Store at 20–25°C (68–77°F); protect from light, moisture, and incompatible substances
Safe Container Materials: Glass vials or ampoules for injectables, high-density polyethylene for bulk material
Storage Compatibility: Separate from oxidizers, strong acids, food, and feed
Occupational Exposure Limits: No established ACGIH or OSHA limits for finished pharmaceutical product; workplace control guidance based on corticosteroid exposure
Engineering Controls: Employ local exhaust ventilation in compounding or bulk handling settings
Personal Protective Equipment: Lab coat, gloves (nitrile preferred), safety goggles, suitable mask/respirator if dust or aerosols are generated
Hygiene Measures: Wash hands before breaks or after handling, avoid contact with skin and eyes, do not eat or drink near handling area
Appearance: White or almost white, crystalline powder
Odor: Odorless or faint characteristic odor
pH (suspension): Slightly acidic to neutral, depending on formulation
Melting Point: 213–216°C
Solubility: Sparingly soluble in water, soluble in methanol, ethanol, and acetone, practically insoluble in hexane
Partition Coefficient: logP 1.56 (estimated)
Flash Point: Data not available, not highly flammable
Boiling Point: Decomposes before boiling
Vapor Pressure: Negligible at room temperature
Bulk Density: Not determined for pure solid material
Stability: Stable under recommended storage conditions
Chemical Stability: Stable at room temperature when protected from light and moisture
Reactive Materials: Strong oxidizing agents, strong acids
Conditions to Avoid: High temperatures, direct sunlight, sources of ignition
Hazardous Decomposition: Produces carbon monoxide, carbon dioxide, possible unknown toxic fumes upon combustion or decomposition
Polymerization: Will not occur under normal storage or use conditions
Acute Toxicity: LD50 (oral, rat) >4000 mg/kg (estimated)
Percutaneous Absorption: May absorb through skin over time, effects similar to systemic corticosteroid use
Chronic Effects: Immunosuppression, endocrine disruption, delayed wound healing, osteoporosis with repeated exposure
Allergenicity: Hypersensitivity possible, particularly with pre-existing allergies
Carcinogenicity/Mutagenicity: Long-term animal studies show mixed results; human risk considered minimal at recommended doses
Reproduction Toxicity: Prolonged/high dose use linked to birth defects and fetal toxicity in animal studies
Aquatic Toxicity: Environmental toxicity data for this compound limited; corticosteroid class has been shown to induce hormonal disruption in aquatic life
Persistence and Degradability: Slowly biodegradable, may persist in soil/water environments
Bioaccumulation Potential: Moderate based on physicochemical properties
Mobility in Soil: Low to moderate mobility based on water solubility and binding to organic matter
Additional Risks: Entry to waterways can impact soil microfauna and aquatic ecosystems; wastewater treatment may not fully remove active compound
Waste Disposal Methods: Incinerate at high temperature in approved facility; do not dispose via household drains
Container Disposal: Triple rinse glassware or vials, puncture and transfer to pharmaceutical waste stream
Environmental Cautions: Minimize release to soil, water, and air; professional waste handler should carry out disposal
Regulatory Recommendations: Follow national or local pharmaceutical waste regulations, consult contractor for large scale disposal
UN Number: Not regulated as dangerous goods for transport under IATA, DOT, or IMDG for finished pharmaceuticals
Transport Hazard Class: Not classified
Packing Group: Not designated
Environmental Hazards: Avoid release to environment, especially near waterways
Special Precautions: Package securely to prevent breakage or contamination during transit
Transport Labeling: Not required for non-bulk, finished formulations; label "Pharmaceutical Product" as recommended by region
FDA/EMA Status: Approved corticosteroid medication; prescription only
OSHA: Not specifically regulated, general chemical hygiene applies
WHMIS (Canada): Not classified as hazardous in finished form
REACH Compliance (EU): Not applicable to finished medicinal products
Other Requirements: Handlers subject to national pharmaceutical workplace guidelines; reporting and inventory based on local health authority may apply
Labeling: Finished drug product to carry full prescription labeling, warnings, and disposal guidance
