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Material Safety Data Sheet for Methylprednisolone Hemisuccinate

Identification

Product Name: Methylprednisolone Hemisuccinate
Common Synonyms: 6α-Methylprednisolone 21-hemisuccinate
CAS Number: 125-02-0
Recommended Use: Pharmaceutical corticosteroid agent
Manufacturer/Supplier: Contact supplier or manufacturer on current label
Emergency Contact: Refer to local country guidelines or Poison Control
Molecular Formula: C25H34O8
Molecular Weight: 462.53 g/mol

Hazard Identification

Classification (GHS): Not classified as hazardous by GHS criteria for pure chemical; medication may cause side effects at higher doses
Main Health Hazards: May cause immunosuppression, skin and eye irritation, digestive upset, possible allergic reactions
Environmental Hazards: Possible hazard to aquatic life in high concentrations
Physical Hazards: No specific fire or explosion hazard
Signal Word: Not applicable for manufactured drug form
Pictogram: Not applicable
Precautionary Statements: Avoid unnecessary exposure, limit dust and inhalation, use PPE for large-scale use

Composition / Information on Ingredients

Chemical Name: Methylprednisolone Hemisuccinate
CAS Number: 125-02-0
Concentration: 100% in pure drug substance form, diluted in formulated products
Impurities: Trace residual solvents possible (pharmaceutical regulations kept below ICH limits)
Mixture: For finished products, excipients listed by lot release documentation

First Aid Measures

Inhalation: Move person to fresh air, monitor for respiratory distress, seek medical attention if symptoms persist
Skin Contact: Remove contaminated clothing, wash skin thoroughly with soap and water, medical advice if rash or irritation develops
Eye Contact: Rinse eyes with plenty of water for 10–15 minutes, remove contact lenses, seek attention if irritation remains
Ingestion: Rinse mouth, do not induce vomiting, seek medical help for symptom management or overdose
Most Important Symptoms: Nausea, vomiting, headache, allergic symptoms, adrenal suppression on repeated large exposure
Advice to Physicians: Supportive care, symptomatic treatment, steroids in overdose handled with established protocols

Fire-Fighting Measures

Suitable Extinguishing Media: Water spray, dry chemical powder, foam, carbon dioxide
Unsuitable Media: No specific restrictions known
Specific Hazards Arising: Decomposition may release carbon oxides and other hazardous gases
Protective Equipment: Firefighters should use full protective clothing and self-contained breathing apparatus
Explosion Data: Sensitivity not observed in standard testing conditions

Accidental Release Measures

Personal Precautions: Use appropriate PPE (gloves, mask, goggles) to prevent skin or eye contact
Environmental Precautions: Prevent spill from reaching water systems or soil
Containment Methods: Scoop up spill with inert absorbent material, place in labeled waste container
Cleanup: Wash affected area with water and suitable detergent, ventilate space, avoid creating dust

Handling and Storage

Precautions for Safe Handling: Minimize dust, avoid inhalation and contact with skin or eyes, use local exhaust in bulk production settings
Storage Conditions: Store at controlled room temperature, typically 15–30°C
Incompatibilities: Avoid contact with strong oxidizers, acids, alkalis
Packaging Requirements: Keep tightly closed, protected from light, use original or approved pharmaceutical containers

Exposure Controls and Personal Protection

Occupational Exposure Limits: No established ACGIH or OSHA limits; use good hygiene practice
Engineering Controls: Local exhaust ventilation recommended in manufacturing areas
Personal Protective Equipment: Gloves (nitrile or latex), goggles, laboratory coat, mask (N95/P2) for powders
Environmental Exposure Controls: Avoid discharge to surface waters and sewers

Physical and Chemical Properties

Appearance: White to off-white crystalline powder
Odor: Odorless
Odor Threshold: Not applicable
pH: 6.0–8.0 (1% solution)
Melting Point: 220–230°C (decomposes)
Boiling Point: Not applicable (decomposes)
Solubility: Freely soluble in water
Partition Coefficient (log Kow): Not available
Vapor Pressure: Negligible
Flash Point: Not determined
Viscosity: Not applicable
Density: Approx. 1.3 g/cm³

Stability and Reactivity

Chemical Stability: Stable under pharmaceutical storage conditions
Possibility of Hazardous Reactions: No hazardous polymerization
Conditions to Avoid: Excess heat, incompatible chemicals, light
Incompatible Materials: Strong acids, strong bases, oxidizing agents
Hazardous Decomposition Products: Carbon monoxide, carbon dioxide, irritating fumes if burned

Toxicological Information

Acute Toxicity: Oral LD50 (rat) > 2,000 mg/kg, low acute hazard
Chronic Effects: Adrenal suppression, osteoporosis, immune suppression with prolonged use
Routes of Exposure: Inhalation, skin absorption, ingestion
Symptoms: Skin/eye irritation, gastrointestinal disturbance, long-term effects as for other corticosteroids
Sensitization: Allergic reactions possible
Mutagenicity: Not mutagenic in standard tests
Carcinogenicity: Not listed as carcinogen by IARC/NTP/OSHA
Reproductive Toxicity: Fetal risk at high interventional doses (as with all glucocorticoids)

Ecological Information

Ecotoxicity: Not highly toxic to aquatic species at expected discharge concentrations; avoid large releases
Persistence and Degradability: Readily biodegradable under environmental conditions
Bioaccumulative Potential: Low (based on structure and pharmacokinetic data)
Mobility in Soil: Moderate, may leach if released in significant quantities
Other Adverse Effects: None known from clinical discharge levels

Disposal Considerations

Waste Disposal Method: Incinerate or dispose in accordance with local, regional, and national regulations for pharmaceutical wastes
Contaminated Packaging: Dispose as hazardous waste; triple rinse containers if required
Special Precautions: Avoid release to environment, follow controlled substance disposal policies

Transport Information

UN Number: Not regulated as dangerous good
Proper Shipping Name: Not applicable
Transport Hazard Class: Not classified as hazardous for transport
Packing Group: Not assigned
Environmental Hazards: Not a marine pollutant
Special Precautions: Secure containers to prevent leaks; avoid transport with hazardous oxidizers

Regulatory Information

TSCA: Not listed for pharmaceutical use
US Federal Regulation: Not hazardous substance under OSHA; covered by FDA drug regulations
European Union: Subject to medicinal product directives, not REACH registered as industrial chemical
WHMIS: Not controlled product
Other Information: Compliance with GMP and local pharmaceutical laws required for handling and disposal