Product Name: Erythromycin, 4-O-beta-D-galactopyranosyl-D-gluconate (salt)
Chemical Formula: C37H67NO13 · C12H20O12
Trade Names: Erythromycin-Galactogluconate
Synonyms: Erythromycin derivative
Recommended Use: Pharmaceutical ingredient, antibiotic use
Manufacturer: Listed supplier information required for traceability
Emergency Contact: Company emergency hotline, Poison Control Center
CAS Number: Contact supplier for current identification
UN Number: Not regulated under most transport regulations (check for updates)
GHS Classification: Not classified as hazardous under GHS criteria for this compound yet precautions apply
Signal Word: Warning
Hazard Statements: May cause mild irritation if inhaled, swallowed, or in contact with skin; potential allergenic effects in some users; exposure may contribute to resistance development
Symbol: Exclamation mark in some regulatory regimes
Precautionary Statements: Avoid breathing dust; wash hands after handling; use with adequate ventilation; in case of respiratory symptoms, seek medical advice
Active Ingredient: Erythromycin, pharmaceutical grade, minimum 95% purity
Salt Component: 4-O-beta-D-galactopyranosyl-D-gluconate, quantity varies by batch, specified per lot
Additive Content: Trace levels of manufacturing byproducts, documented via quality assessment
Impurities: Routine screening for heavy metals and residual solvents
Formulation Data: White to off-white powder, odorless
Inhalation: Remove victim to fresh air, keep at rest, seek medical attention if symptoms develop
Skin Contact: Wash with soap and plenty of water, remove contaminated clothing, medical advice for persistent irritation
Eye Contact: Rinse immediately with water for at least 15 minutes, consult physician
Ingestion: Rinse mouth, do not induce vomiting, drink water, consult healthcare professional promptly
Advice for Providers: Symptomatic treatment recommended; allergy potential taken into account
Extinguishing Media: Water spray, dry chemical, foam, carbon dioxide
Special Hazards: May emit toxic fumes under fire conditions, such as nitrogen oxides and carbon oxides
Protective Equipment: Self-contained breathing apparatus, full protective gear
Firefighting Procedures: Apply conventional techniques, keep run-off out of water sources
Personal Protection: Wear protective gloves, safety goggles, dust mask
Spill Control: Avoid creating dust, ventilate area
Cleanup Methods: Collect spilled material with damp cloth or absorbent, dispose in closed container
Environmental Precautions: Prevent release into sewage systems or watercourses, contact local authorities if large quantities escape
Disposal: Use licensed chemical waste disposal contractors following local regulations
Handling: Use in well-ventilated areas, avoid inhaling dust or vapors, prevent contact with eyes and skin, wash after handling
Storage: Store in tightly closed containers, cool and dry location away from light and incompatible substances, temperature not to exceed 25°C, segregate from strong acids and oxidizers
Special Precautions: Keep out of reach of children and unauthorized personnel; ensure containers labeled correctly
Occupational Exposure Limits: Not established for this specific compound, limit dust exposure, use prudent industrial hygiene practices
Engineering Controls: Local exhaust, general room ventilation
Personal Protection: Use approved safety goggles, lab gloves, lab coat; use dust mask for routine handling
Hygiene Measures: Never eat, drink, or smoke in work area, wash hands thoroughly after handling, remove contaminated clothing promptly
Physical State: Solid; powder
Color: White to off-white
Odor: Odorless or faint antibiotic odor
Melting Point: Not specific due to salt component
Boiling Point: Decomposes before boiling
Solubility: Moderately soluble in water, sparingly soluble in organic solvents
pH (solution): 5.5–7.5 (in aqueous solution)
Partition Coefficient: Data available from supplier for each batch
Vapor Pressure: Negligible at room temperature
Flash Point: Not applicable for solid form
Stability: Stable under recommended storage conditions
Chemical Stability: Stable under recommended handling and storage
Conditions to Avoid: High temperatures, light, moisture
Incompatible Materials: Strong acids, strong oxidizers
Decomposition Products: Oxides of carbon, nitrogen, and possibly toxic gases under fire
Polymerization: Not expected under normal conditions
Acute Effects: Irritation of eyes, skin, respiratory tract; rare cases of hypersensitivity reactions
Chronic Effects: Prolonged or repeated occupational exposure may cause skin sensitization or allergic response; occupational monitoring advised for susceptible individuals
Target Organs: Possible mild effects on gastrointestinal tract if ingested
Carcinogenicity: Not listed as carcinogenic by IARC, NTP, OSHA
Genotoxicity: No evidence in standard tests; safety margin depends on exposure frequency
Other Effects: May contribute to antibiotic resistance in environmental and occupational settings
Toxicity to Aquatic Life: Harmful in large quantities to aquatic organisms, especially algae and bacteria
Persistence: Compound degrades slowly in soil and water environments
Bioaccumulation: Not expected to bioaccumulate significantly due to molecular size and solubility
Mobility: Water solubility favors dispersion, but risk to microorganisms is elevated on discharge
Special Considerations: Limit discharge to surface water, promote practices that reduce environmental exposure
Waste Handling: Treat unused material as hazardous waste
Contaminated Packaging: Clean containers before recycling or dispose in accordance with local regulation
Disposal Method: Incinerate or landfill under conditions set by local environmental agencies
Best Practices: Employ drug take-back programs, consult local environmental protection resources
Precautions: Do not flush into sewer, keep out of landfill unless approved
UN Number: Not classified as dangerous for transport under international ADR, IATA, IMDG codes
Transport Hazard Class: Non-hazardous
Packing Group: Not applicable
Shipping Precautions: Protect from physical damage, excessive heat, moisture; ensure containers labeled
Labeling: Ship labeled as pharmaceutical active ingredient
TSCA Status: Not listed
EPCRA/SARA: Not listed as an extremely hazardous substance
EU Classification: Regulated as a medicinal product; notification requirements for pharmaceutical activities
OSHA: General safety compliance in handling hazardous drugs
Other: National inventories or guidelines (REACH, WHMIS, GHS) reviewed for changes; consult with regulatory experts on emerging standards
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