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Product Name: Doxycycline Hyclate Monohydrate
Synonyms: Doxycycline Hydrochloride Hemihydrate, Vibramycin Hyclate
Chemical Family: Tetracycline antibiotics
Molecular Formula: C22H24N2O8 · C2H6O4S · H2O
CAS Number: 24390-14-5
Intended Use: Pharmaceutical ingredient for treatment of infection, veterinary applications
Supplier Details: Manufacturer information typically found on product label, including emergency contact phone number
Recommended Restrictions: Not for use except as prescribed by qualified personnel
Product Code: Refer to internal documentation for specific lot numbers
GHS Classification: Acute Toxicity—Oral, Category 4; Skin Sensitization, Category 1; Eye Irritation, Category 2
Signal Word: Warning
Hazard Statements: Harmful if swallowed. Causes serious eye irritation. May cause an allergic skin reaction.
Pictograms: Exclamation mark
Precautionary Statements: Avoid breathing dust; avoid contact with skin and eyes; wash hands thoroughly after handling; wear protective gloves, lab coat, eye protection
Potential Health Effects: Inhalation and skin contact may cause allergic reaction, eye and mucous membrane irritation, gastrointestinal disturbances, rare but possible photosensitivity. Prolonged exposure may affect kidney and liver function.
Chemical Name: Doxycycline Hyclate Monohydrate
Common Name: Doxycycline
Concentration: Typically above 98% as supplied
CAS Number: 24390-14-5
Impurities: May contain trace levels of related tetracycline compounds and excipients depending on source
Skin Contact: Wash with soap and plenty of water for at least 15 minutes, remove contaminated clothing; seek medical attention if irritation develops.
Eye Contact: Rinse cautiously with water for several minutes, remove contact lenses if present, continue rinsing, get medical advice.
Inhalation: Move to fresh air, keep person comfortable for breathing, seek medical attention if symptoms occur.
Ingestion: Rinse mouth, do not induce vomiting, get medical attention immediately.
Most Important Symptoms: Redness of skin or eyes, local irritation, headache, nausea, allergic reaction.
Advice for Physicians: Treat symptomatically, support respiratory and cardiovascular functions as required.
Suitable Extinguishing Media: Water spray, foam, carbon dioxide, dry chemical powder
Unsuitable Extinguishing Media: No specific restrictions known
Specific Hazards: Thermal decomposition can produce toxic fumes including carbon oxides, nitrogen oxides, sulfur oxides
Special Protective Equipment for Firefighters: Full protective gear, self-contained breathing apparatus (SCBA)
Fire Fighting Procedures: Evacuate area, contain run-off water to prevent environmental contamination
Personal Precautions: Wear suitable personal protective equipment including gloves, gown, eye protection, suitable respiratory protection for dust
Environmental Precautions: Prevent further leakage or spillage if safe to do so, keep out of drains and watercourses
Methods for Containment and Cleaning Up: Collect spilled material using damp disposable towels or HEPA vacuum, avoid raising dust, transfer to suitable waste container for disposal, clean area with detergent and water
Reference to Other Sections: For disposal and personal protection, refer to corresponding sections
Safe Handling: Handle in a well-ventilated area, avoid creating dust, use approved biological safety cabinet for weighing or transfer, minimize contact with skin and eyes, do not eat or drink near product
Storage Conditions: Store tightly closed in original container, in a cool, dry, well-ventilated place, protected from light and moisture
Incompatibilities: Avoid contact with acids, oxidizing agents
Special Requirements: Restrict access to authorized personnel, keep logs for inventory control, store away from food, drinks, and animal feed
Occupational Exposure Limits: No established OSHA, ACGIH, or NIOSH limits; handle as potential human pharmaceutical agent
Engineering Controls: Local exhaust ventilation or fume hood as standard; use closed systems for transfer and weighing
Personal Protective Equipment: Protective gloves (nitrile or latex), laboratory coat, safety goggles or face shield, approved respirator for respiratory protection (N95 or P100 rated for particulates); routine hand washing
Hygiene Practices: Remove contaminated clothing and wash before reuse, do not smoke or eat in work area, wash hands thoroughly after handling
Appearance: Yellow to greenish-yellow crystalline powder
Odor: Odorless or slight chemical scent
Odor Threshold: Not available
pH: 2.0 - 3.0 (10% aqueous solution)
Melting Point/Freezing Point: 170–205 °C (decomposes)
Initial Boiling Point and Boiling Range: Decomposes before boiling
Flash Point: Not applicable
Evaporation Rate: Not applicable
Flammability: Not flammable
Vapor Pressure: Negligible
Vapor Density: Not available
Relative Density: 1.5–1.6 g/cm3 (approximate)
Solubility: Freely soluble in water, moderate in methanol, almost insoluble in most organic solvents
Partition Coefficient (n-octanol/water): Not available
Auto-ignition Temperature: Not determined
Decomposition Temperature: Decomposes on heating
Viscosity: Not applicable (solid material)
Explosive Properties: None identified
Oxidizing Properties: Not considered oxidizing
Stability: Chemically stable under recommended storage, degrades in presence of light, moisture, excessive heat
Reactivity: Not chemically reactive under normal conditions
Hazardous Reactions: No dangerous reactions known under normal use
Conditions to Avoid: Exposure to light, moisture, incompatible chemicals
Incompatible Materials: Strong acids, strong alkalies, oxidizing agents
Hazardous Decomposition Products: Decomposition may yield toxic fumes including nitrogen oxides, sulfur oxides, and carbon monoxide
Likely Routes of Exposure: Skin, eyes, inhalation, ingestion
Acute Toxicity: LD50 (oral, rat): approximately 1000–2000 mg/kg; inhalation studies not available; can cause nausea, vomiting, diarrhea, headache if ingested in large amounts
Skin Corrosion/Irritation: May cause mild to moderate irritation on repeated contact
Serious Eye Damage/Irritation: May cause redness and discomfort
Sensitization: May provoke allergic responses in sensitized individuals
Chronic Effects: May impair liver or kidneys with persistent overexposure, rare risk of drug-induced lupus, photosensitivity
Carcinogenicity: Not listed as carcinogen by IARC, NTP, OSHA
Mutagenicity: No definitive human data available
Reproductive Toxicity: Avoid during pregnancy; potential risk of fetal toxicity as shown in animal studies
Other Data: Antibiotic resistance potential if released in sufficient quantity
Ecotoxicity: Moderately toxic to aquatic organisms (algae, crustacea, fish) at higher concentrations, may disturb microbial populations in natural waters, resistance development in environmental bacteria
Persistence and Degradability: Slowly degradable in environment, persistent compounds may form
Bioaccumulation Potential: Low due to solubility but accumulation possible in aquatic invertebrates
Mobility in Soil: Can leach from soil in some conditions with rainfall, binds with sediments
Other Adverse Effects: Hazard for antibiotic resistance propagation, potential for long-term impact on wastewater treatment systems
Waste Treatment Methods: Incineration at high temperature recommended where allowed; chemical decomposition possible for small quantities; avoid landfill disposal where runoff possible
Disposal of Contaminated Packaging: Rinse thoroughly, dispose as hazardous pharmaceutical waste
Precautions: Do not dispose in household trash or regular wastewater streams, ensure all personnel use PPE during cleanup
Waste Codes: Pharmaceutical waste codes may apply based on local/national regulations
UN Number: Not regulated for transport under ADR, RID, IMDG, IATA
Proper Shipping Name: Doxycycline Compound, non-hazardous for transportation
Transport Hazard Class: Not classified as dangerous goods
Packing Group: Not applicable
Label Requirements: None for non-hazardous quantities but consult local regulations and internal guidelines
Special Precautions: Keep container sealed, upright; ship away from extreme heat, moisture, incompatible cargo
Safety, Health, Environmental Regulations: Product subject to regulations for pharmaceuticals, veterinary or medicated feed additives; not on US EPA TSCA Inventory; not subject to SARA Title III, Section 313 reporting; not listed under California Proposition 65
OSHA Status: Not specifically regulated as hazardous but treat as occupational health risk
WHMIS Classification: D2B—Toxic Material Causing Other Toxic Effects (Canada)
Inventory Status: Subject to national or regional pharmaceutical inventory and prescription requirements
Other Requirements: Handle and report losses, spills, and significant exposures according to local protocols, ensure specific labeling and record-keeping as per Good Manufacturing Practices or site SOPs.
