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Material Safety Data Sheet (MSDS) for Erythromycin Base

Identification

Product Name: Erythromycin Base
Chemical Name: (3R,4S,5S,6R,7R,9R,11R,12R,13S,14R)-4-[(2,6-Dideoxy-3-C-methyl-3-O-methyl-α-L-ribo-hexopyranosyl)oxy]-14-ethyl-7,12,13-trihydroxy-3,5,7,9,11,13-hexamethyl-6-[[3,4,6-trideoxy-3-(dimethylamino)-β-D-xylo-hexopyranosyl]oxy]oxacyclotetradecane-2,10-dione
CAS Number: 114-07-8
Recommended Use: Antibiotic in pharmaceutical formulations
Synonyms: Erythromycin (anhydrous), Erythrocin

Hazard Identification

Classification: According to OSHA HCS (2012), Erythromycin Base is not classified as hazardous
Signal Word: None
Hazard Statements: May cause allergic skin reaction, eye irritation in sensitive individuals
Pictograms: None required
Routes of Exposure: Inhalation, skin, eye, ingestion
Target Organs: Skin, eyes, respiratory system

Composition / Information on Ingredients

Component: Erythromycin Base
Concentration: >97% (active ingredient)
Impurities: Residual solvents and related substances below pharmacopeial limits
Molecular Formula: C37H67NO13
Molecular Weight: 733.94 g/mol

First Aid Measures

Eye Contact: Remove contact lenses, flush cautiously with plenty of water for at least 15 minutes, seek medical attention if irritation develops
Skin Contact: Remove contaminated clothing, wash skin gently with soap and water, get medical help for rash or irritation
Inhalation: Move to fresh air, monitor for symptoms, medical advice if persistent discomfort or respiratory distress
Ingestion: Rinse mouth thoroughly with water, do not induce vomiting, medical attention if significant amounts swallowed or symptoms arise
Most Important Symptoms/Effects: Allergic reactions include rash, swelling, difficulty breathing, gastrointestinal discomfort (nausea, vomiting, diarrhea)

Fire-Fighting Measures

Suitable Extinguishing Media: Dry chemical, carbon dioxide, foam, water spray
Specific Hazards: Combustion may release toxic fumes of oxides of nitrogen, carbon monoxide, carbon dioxide
Protective Equipment: Firefighters require self-contained breathing apparatus, full protective clothing
Special Procedures: Cool adjacent containers with water spray to prevent overheating

Accidental Release Measures

Personal Protection: Avoid dust generation, wear gloves, goggles, NIOSH-approved respirator
Spill Cleanup: Ventilate area, sweep up into suitable disposal container, avoid direct contact
Environmental Protection: Prevent release into sewers and waterways, report significant spills to local authorities
Disposal: Clean residues with wet methods to control dust, follow local disposal regulations

Handling and Storage

Handling: Work in well-ventilated area, minimize dust, avoid inhalation and contact with skin or eyes, wash hands after handling
Storage: Store in closed, airtight containers, away from light, moisture, and incompatible materials (strong oxidizing agents)
Temperature: Recommended storage between 2°C and 8°C
Other Precautions: Separate from foodstuffs or animal feed, label clearly

Exposure Controls and Personal Protection

Engineering Controls: Local exhaust ventilation, process enclosures to limit airborne dust
Personal Protective Equipment (PPE): Chemical-resistant gloves (nitrile or latex), protective goggles, lab coat, dust mask or respirator if dust forms
Hygiene Measures: No smoking, eating, or drinking in work area, wash hands and arms before breaks and after work

Physical and Chemical Properties

Appearance: White to pale yellow powder
Odor: Almost odorless, slight characteristic
Melting Point: 135–140°C
pH: 8–10 (1% aqueous suspension)
Solubility: Insoluble in water, freely soluble in acetone and ethanol, sparingly soluble in methanol
Boiling Point: Not applicable (decomposes upon heating)
Vapor Pressure: Low, negligible under normal conditions
Density: Approximately 1.05 g/cm³
Stability: Stable under recommended storage, decomposes under heat or light

Stability and Reactivity

Chemical Stability: Stable at recommended storage conditions
Incompatible Materials: Strong oxidizing agents, strong acids and bases
Conditions to Avoid: Heat, moisture, light, air exposure
Hazardous Decomposition Products: Carbon monoxide, carbon dioxide, nitrogen oxides
Polymerization: Not expected under normal conditions

Toxicological Information

Acute Toxicity: Oral LD50 (rat): >5000 mg/kg
Skin Corrosion/Irritation: Not classified as an irritant, dermal sensitization possible
Eye Damage/Irritation: Mild to moderate irritation possible
Respiratory Effects: Irritation to respiratory tract reported after inhalation of large amounts
Skin Sensitization: Allergic contact dermatitis reported in occupational exposure
Chronic Effects: Prolonged exposure may contribute to resistance in bacteria
Carcinogenicity: Not listed as a carcinogen by IARC, NTP, ACGIH, or OSHA
Reproductive Toxicity: No definitive evidence of reproductive or developmental toxicity in humans

Ecological Information

Ecotoxicity: Harmful to aquatic organisms at elevated concentrations, risk of resistance development in bacteria and algae
Persistence and Degradability: Slowly biodegradable, persistent antibiotic activity in aquatic environments
Bioaccumulation: Limited evidence for bioaccumulation in aquatic organisms
Mobility in Soil: Moderate sorption to soil, may leach into groundwater under some conditions
Other Adverse Effects: Can disrupt aquatic microbial communities

Disposal Considerations

Disposal Methods: Dispose in accordance with local, state, and federal regulations as pharmaceutical or chemical waste, incineration preferred
Special Precautions: Avoid release to environment, do not dispose of via drains or household waste
Contaminated Packaging: Rinse containers thoroughly before disposal, manage as hazardous waste

Transport Information

UN Number: Not regulated for transport
Proper Shipping Name: Not classified as dangerous goods
Transport Hazard Class: None
Packing Group: Not applicable
Special Precautions for User: Avoid spillage, ensure container integrity during transport

Regulatory Information

OSHA Status: Not classified as hazardous
TSCA Inventory: Not listed for active commercial use
DSL (Canada): Not listed
EC Inventory: Listed as an active pharmaceutical ingredient
Other Regulations: Subject to local pharmaceutical and environmental regulations, requires careful workplace control and reporting in some jurisdictions
Labeling Requirements: Name, hazard information, manufacturer and emergency contact must be clearly shown on container