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Product Name: Roxatidine Acetate Hydrochloride
Synonyms: Roxatidine HCl, Roxatidine Monoacetate Hydrochloride
Chemical Formula: C19H28N4O8S•HCl
CAS Number: 78273‐80‐0
Recommended Use: Active pharmaceutical ingredient used for gastrointestinal treatments
Supplier Details: Pharmaceutical manufacturers, research laboratories
Emergency Phone: Refer to manufacturer’s safety department contact
GHS Classification: Not classified as dangerous according to GHS
Main Hazards: May cause irritation to skin, eyes, and respiratory tract upon contact
Routes of Exposure: Inhalation, ingestion, skin, eye
Signal Word: Warning
Hazard Statements: Dust creates mild respiratory irritation, prolonged exposure increases health risks
Precautionary Statements: Avoid breathing dust, prevent skin and eye contact, wash hands thoroughly after handling, wear appropriate protection
Chemical: Roxatidine Acetate Hydrochloride
Concentration: >98%
Impurities: May contain trace levels of residual solvents or manufacturing byproducts
Molecular Weight: 522.98 g/mol
Inhalation: Remove person to fresh air, seek medical attention if symptoms persist
Skin Contact: Wash affected area with plenty of water, remove contaminated clothing, consult physician if irritation develops
Eye Contact: Flush eyes with water for at least fifteen minutes, consult physician immediately
Ingestion: Rinse mouth, if conscious give small amount of water, do not induce vomiting, seek medical assistance
Symptoms and Effects: Irritation, headache, dizziness may occur after exposure
Suitable Extinguishing Media: Water spray, dry chemical, carbon dioxide, foam
Unsuitable Media: High-pressure water streams may spread powder
Fire Hazards: Dust may form combustible mixture, fight fire wearing self-contained breathing apparatus
Decomposition Products: Emits toxic fumes such as nitrogen oxides, sulfur oxides, hydrogen chloride under combustion
Special Equipment for Firefighters: Use full protective clothing, NIOSH approved respirator
Personal Precautions: Avoid contact with skin, eyes, clothing, avoid breathing dust
Protective Equipment: Wear gloves, goggles, laboratory coat, mask
Environmental Precautions: Do not release into drains or surface water
Cleanup Methods: Sweep up without creating dust, collect in suitable container, ventilate area, wash spill site
Handling: Operate with adequate ventilation, avoid inhaling dust, prevent static discharge, use only in secure laboratory conditions
Hygiene Recommendations: Wash hands after use, prevent food and beverage contact, remove protective clothing before leaving area
Storage: Store at controlled room temperature, keep tightly sealed in original container, protect from light, moisture, and incompatible materials
Incompatibilities: Strong oxidizing agents, strong acids, bases
Engineering Controls: Work with local exhaust ventilation or fume hood
Exposure Limits: Not established for this substance
Personal Protective Equipment: Chemical resistant gloves (nitrile), safety goggles, protective laboratory apparel, dust mask or respirator
Other Protective Measures: Emergency eyewash and shower easily accessible
Appearance: White to off-white crystalline powder
Odor: Odorless
Odor Threshold: Not applicable
pH: Around 3.0 in 1% aqueous solution
Melting Point: 211–216°C (decomposes)
Boiling Point: Not applicable (decomposes)
Flash Point: Non-flammable
Solubility: Freely soluble in water, slightly soluble in methanol, insoluble in ether
Partition Coefficient (log Kow): Data not available
Vapor Pressure: Negligible
Density: Not determined
Evaporation Rate: Not applicable
Viscosity: Not applicable
Chemical Stability: Stable under normal temperatures and pressures
Reactivity: No dangerous reactions expected under normal conditions
Hazardous Reactions: Reacts with strong oxidizers, acids, bases
Decomposition Products: Thermal decomposition produces toxic fumes including hydrogen chloride, nitrogen, sulfur compounds
Polymerization: Will not occur
Routes of Exposure: Inhalation, ingestion, skin, eyes
Acute Toxicity: Oral LD50 (rat): >2000 mg/kg
Skin Corrosion/Irritation: May cause mild irritation
Eye Damage/Irritation: Causes redness, tearing on contact
Respiratory Effects: Prolonged inhalation of dust may cause lung irritation
Sensitization: No data available for sensitization
Mutagenicity: Not classified as mutagenic based on available studies
Carcinogenicity: No evidence identified in animal or epidemiological studies
Reproductive Toxicity: No significant adverse effects observed in reproductive studies
Ecotoxicity: No acute or chronic risks identified at low environmental concentrations
Persistence and Degradability: Not rapidly biodegradable in standard tests
Bioaccumulation Potential: Expected low due to low log Kow
Mobility in Soil: Likely moderate, substance is water soluble
Other Adverse Effects: Limit release to aquatic and terrestrial environments to mitigate risk
Waste Disposal Methods: Address as pharmaceutical waste, follow local environmental regulations, incinerate in suitable facility after mixing with flammable material
Container Disposal: Triple rinse airtight containers, render unusable before landfill or incineration
Precautions: Prevent environmental release, avoid contamination of soil and water
UN Number: Not assigned
Proper Shipping Name: Not regulated as dangerous goods
Transport Hazard Class: Not classified
Packing Group: Not applicable
Environmental Hazards: Not considered marine pollutant
Special Precautions: Prevent container damage, maintain integrity of packaging during shipping, avoid contact with oxidizing substances
International Inventories: Roxatidine Acetate Hydrochloride not listed in major chemical inventories as hazardous
Regulation under OSHA: No specific hazards identified
EU Regulation: Not classified as hazardous under Regulation (EC) No 1272/2008
TSCA: Not listed
REACH Status: Not registered, exempt for use as pharmaceutical
Other Regulations: Handle following local, state, national, and international chemical safety requirements
