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Product Name: Erythromycin Ethylsuccinate
CAS Number: 1264-62-6
Chemical Family: Macrolide antibiotic
Formula: C43H75NO16
Synonyms: EES, Ethylsuccinate ester of erythromycin
Manufacturer: Listed by chemical supplier, information available on request
Recommended Use: Treatment of bacterial infections, prescription medication
Contact Information: Emergency contact and local poison control details found on prescription or package leaflet
Emergency Overview: Oral antibiotic tablet or suspension, not for environmental or laboratory raw use, direct handling instructions provided on container
Classification: Not considered hazardous under GHS for standard handling; consult workplace standards for bulk quantities
Signal Word: None required for single dosage forms; “Warning” may be used in case of dust or powder form
Hazard Statements: May cause allergic skin or respiratory reaction in sensitized individuals; ingestion may cause gastrointestinal upset
Precautionary Statements: Avoid unnecessary dust generation; do not breathe powder or vapors; avoid skin and eye contact
Symptoms of Exposure: Allergic reaction, itching, rash, gastrointestinal distress, headache, rarely cholestatic jaundice
Chemical Name: Erythromycin Ethylsuccinate
Concentration: Typically 100% for raw API or as labeled for tablets/suspension; formulation may contain excipients such as sorbitol, microcrystalline cellulose, povidone, sodium lauryl sulfate, coloring agents, flavors, and sweeteners
Impurities: Low levels of related erythromycin components and residual solvents as per pharmacopeia limits; no other hazardous impurities noted
General Advice: Remove from exposure source; obtain medical attention promptly
Inhalation: Move person to fresh air, maintain breathing; seek medical help if coughing or allergic symptoms develop
Skin Contact: Wash thoroughly with water and mild soap; remove contaminated clothing
Eye Contact: Flush eyes gently with plenty of water for 15 minutes, lifting upper and lower eyelids occasionally; seek evaluation for persistent irritation
Ingestion: Do not induce vomiting; rinse mouth and consider medical attention, especially for large or unintended consumption or in children; support treatment according to symptoms
Most Important Symptoms/Effects, Acute or Delayed: Nausea, diarrhea, hypersensitivity reactions, liver dysfunction (rare and usually with prolonged or high-dose exposure)
Suitable Extinguishing Media: Water spray, foam, dry chemical, carbon dioxide; select method appropriate for surrounding area
Unsuitable Extinguishing Media: None known for this compound
Fire Hazards: In case of fire, thermal decomposition may produce hazardous gases such as nitrogen oxides, carbon monoxide, and carbon dioxide
Protective Equipment: Wear self-contained breathing apparatus and full protective gear
Special Hazards: Dust can form explosive mixtures with air in rare concentrated conditions; consider methods that minimize dust
Personal Precautions: Wear protective gloves, mask, and eyewear; prevent skin and respiratory exposure, especially if large spill or powder
Environmental Precautions: Prevent runoff to sewers or waterways; notify relevant authorities if significant contamination threatens the environment
Cleanup Methods: Use absorbent material for liquids; carefully scoop or sweep up dry powder, avoiding dust clouds; place into appropriate biohazard or pharmaceutical waste for disposal; wash area with plenty of water after cleanup
Handling: Keep container tightly closed; handle under well-ventilated conditions; minimize physical contact and avoid inhaling dust or vapors; do not eat, drink, or smoke during handling
Storage: Store at controlled room temperature, usually between 20–25°C (68–77°F); keep container in dry place away from light, moisture, and incompatible substances (strong acids/bases, oxidizers); protect from physical damage and keep out of reach of unauthorized personnel
Control Parameters: No established occupational exposure limits for erythromycin ethylsuccinate; company or local standards may supply internal limits for frequent handling in bulk
Engineering Controls: Use local exhaust ventilation for manufacturing or compounding operations; avoid open powder handling without extraction
Personal Protective Equipment: Gloves made of latex, nitrile, or other chemical-resistant materials; safety goggles for eye protection; laboratory coats or aprons for body protection; masks or respiratory protection if dust becomes significant
Hygiene Measures: Wash hands thoroughly after handling; remove contaminated clothing and shower before leaving work area; do not reuse contaminated protective gear until cleaned
Appearance: White to off-white, odorless crystalline powder
Odor: Odorless or faintly characteristic
pH (solution): 7–9 for 1% aqueous suspension
Melting Point: Not sharply defined; decomposes above 135°C
Boiling Point: Not easily determined (decomposes before boiling)
Solubility: Sparingly soluble in water, more soluble in alcohols and organic solvents
Vapor Pressure: Not applicable due to low volatility
Partition Coefficient: Log P (estimated) ~3.06
Density: Not available in standard references; typical of large organic molecules
Stability: Stable under recommended storage conditions
Incompatibilities: Strong acids, strong bases, potent oxidizers
Polymerization: Will not occur
Hazardous Decomposition: Burning or decomposition can produce carbon monoxide, carbon dioxide, and nitrogen oxides; thermal breakdown begins above 135°C
Conditions to Avoid: Prolonged heat, direct sunlight, high humidity, incompatible chemicals
Routes of Exposure: Inhalation, skin/eye contact, ingestion
Acute Toxicity: LD50 (oral, rat) > 5,000 mg/kg, considered relatively low toxicity
Chronic Effects: Allergic reactions (skin, respiratory), reversible liver effects at high doses, gastrointestinal upset common
Mutagenicity: No evidence from standard tests
Carcinogenicity: Not classified as carcinogen by IARC, NTP, OSHA
Reproductive Toxicity: Animal studies do not show heightened risk; consult physician before using in pregnancy or lactation
Sensitization: Hypersensitivity may develop with repeated exposure
Other Effects: Weak QT-prolongation possible in those with predisposed heart rhythm issues
Ecotoxicity: Toxic to aquatic organisms at low concentrations, may cause long-term effects in aquatic environments
Mobility: Not highly mobile in soil; moderate persistence
Degradation: Biodegradable over time, but not rapidly; breakdown products less hazardous
Bioaccumulation: Not expected to significantly bioaccumulate
Aquatic Impact: Discharge in active form can impact wastewater treatment and uncontrolled release may promote antibiotic resistance
Product Disposal: Incinerate in approved facility or follow national, state, or local pharmaceutical waste disposal rules; not for disposal via landfill or sewer
Contaminated Packaging: Dispose of as pharmaceutical waste or medical biohazard; triple rinse before discarding where permitted
Special Instructions: Do not reuse empty containers for household or commercial purposes; keep out of hands of children and unauthorized users
UN Number: Not regulated as a dangerous good for land, sea, or air transport under normal packaging
Proper Shipping Name: Erythromycin Ethylsuccinate or pharmaceutical preparation (as labeled)
Hazard Class: Not hazardous by current international transport criteria
Packing Group: None assigned
Special Precautions: Secure containers to limit tipping, breakage, and unintended release; package to prevent moisture and light exposure
U.S. Regulations: FDA-approved prescription drug, subject to Drug Enforcement Administration and Food and Drug Administration rules; not listed as hazardous under SARA, CERCLA, or RCRA
EU Directives: Covered by EMA regulations for medicinal products; not classified as dangerous for supply, but must follow specific pharmaceutical handling guidance
Other National Inventories: Listed on relevant chemical and health authority inventories; manufacturer’s SDS may detail exact compliance per region
Workplace Classification: Not subject to special workplace restrictions beyond standard pharmaceutical safety and hygiene practices
