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Product Name: Urea, Pharmaceutical Grade
Chemical Name: Carbamide
Synonyms: Urea, Carbonyldiamide, Ureophil
CAS Number: 57-13-6
EC Number: 200-315-5
Recommended Use: Raw material for pharmaceutical formulations, excipients, chemical synthesis
Supplier: Refer to batch label or shipping documents for precise manufacturer contact details
Emergency Phone: Refer to label documentation, as emergency numbers will change by region and supplier
Manufacturing Site Address: Provided on product packaging, often based on licensing jurisdiction
GHS Classification: Not classified as hazardous according to GHS criteria for chemical substances
Main Hazards: May cause mild skin, eye, or respiratory irritation upon prolonged exposure
Label Elements: No signal word or pictogram required; use general safety labeling for pharmaceuticals
Precautionary Statements: Avoid breathing dust; wash hands thoroughly after handling; wear gloves and eye protection to protect skin and eyes
Other Hazards: Not considered flammable, reactive, or acutely toxic in its normal use; not known to sensitize skin under standard working conditions
Chemical Identity: Urea
Concentration: 99-100% pure, with trace amounts of moisture and pharmaceutical-grade excipients (if blended for formulation use)
Impurities: Heavy metals, biuret, and formaldehyde are controlled to meet pharmacopoeia standards (USP, EP)
Solubility Agents: None unless specified by formulation needs
Other Components: None declared for pharmaceutical grade; always check batch-specific certificate of analysis for detailed breakdown
Inhalation: Move person to fresh air; consult a physician if symptoms (coughing, respiratory irritation) persist
Skin Contact: Remove contaminated clothing; rinse exposed skin with water; use mild soap if available; seek medical attention for irritation
Eye Contact: Flush eyes gently with plenty of water for several minutes, ensuring eyelids are held open; consult a doctor if discomfort continues
Ingestion: Rinse mouth thoroughly; drink water if conscious and alert; do not induce vomiting; get medical advice as needed
Notes for Doctors: Provide symptomatic care; no specific antidote or treatment required based on known toxicology
Flammability: Not explosive or highly flammable; urea decomposes above 133°C
Suitable Extinguishing Media: Use water spray, dry chemical, carbon dioxide, or foam for surrounding fire control
Unsuitable Media: Avoid high-pressure water jets, which can spread powder
Decomposition Products: Ammonia, oxides of nitrogen, and carbon dioxide form with strong heat or fire
Special Protective Equipment: Firefighters should wear self-contained breathing apparatus (SCBA) and chemical-resistant clothing; use adequate ventilation
Firefighting Tips: Remove containers from area if safe; cool residual containers with water spray to prevent decomposition fumes
Personal Precautions: Avoid inhaling dust; use gloves, goggles, and dust mask for direct contact and cleanup
Environmental Precautions: Prevent product from reaching drains, natural waters, or soil in bulk quantities
Clean-Up Methods: Sweep up gently to minimize dust; collect in a clean, dry, clearly labeled container for reuse or disposal; wash residual area with plenty of water
Spill Reporting: Notify relevant authorities for significant spills, especially near water sources
Special Advice: Use anti-slip mats or dry material if spills make floor slippery; ventilate area well during cleanup
Handling Precautions: Handle in well-ventilated areas; avoid creating or inhaling dust; wear personal protection such as gloves and goggles
Safe Practices: Do not eat, drink, or smoke while managing product; clean hands before breaks, meals, and after work
Storage Conditions: Keep containers tightly closed in a cool, dry, well-ventilated space; avoid exposure to humidity and direct sunlight
Incompatibilities: Segregate from oxidizing agents, acids, nitrites, and chlorates; urea can react with hypochlorites or nitrites to form hazardous gases
Packing Materials: Use containers made from plastic, glass, or corrosion-resistant metal
Occupational Exposure Limits: No permitted exposure limit for urea, but reduce prolonged dust contact
Engineering Controls: Use local exhaust or process enclosures to keep airborne concentrations low; provide eyewash stations in work areas
Personal Protective Equipment: Wear safety goggles, chemical-resistant gloves, and dust masks when necessary
Respiratory Protection: Use dust respirators for high-dust environments or spills
Hygiene Measures: Wash hands and arms before breaks; change out of soiled clothing; do not handle contact lenses in contaminated environments
Appearance: White crystalline powder or granules
Odor: Odorless or very faint ammonia-like smell
Molecular Weight: 60.06 g/mol
Melting Point: 132.7°C (decomposes at melting point)
Solubility: Highly soluble in water, limited solubility in alcohol, insoluble in chloroform and ether
pH: Neutral to slightly alkaline in aqueous solutions
Density: 1.32 g/cm³
Vapor Pressure: Negligible at ambient temperatures
Partition Coefficient (n-octanol/water): -2.11
Other Physical Data: Stable under normal temperature and pressure
Chemical Stability: Stable under standard laboratory and handling conditions
Conditions to Avoid: Prolonged exposure to temperatures above 60°C can cause decomposition; avoid excess water, strong sunlight, and high humidity
Materials to Avoid: Strong oxidizers, nitrates, nitrites, acids, alkalis, sodium hypochlorite
Hazardous Decomposition Products: Ammonia, nitrogen oxides, biuret, and isocyanic acid form at high temperatures
Polymerization: Polymerization does not occur
Acute Toxicity: Oral LD50 (rat): approximately 14,500 mg/kg; low toxicity for humans in intended use
Skin Irritation: Not a skin sensitizer or severe skin irritant; direct contact may cause drying
Eye Irritation: May cause mild irritation with prolonged exposure
Respiratory Effects: Temporary irritation of airways possible with dust inhalation
Chronic Exposure: Minimal health risks reported with pharmaceutical use; no carcinogenic, mutagenic, or teratogenic effects known in humans
Notes on High Dosage: Ingesting large quantities may cause nausea, vomiting, or diarrhea
Eco-Toxicity: Low toxicity to aquatic organisms at levels found in typical pharmaceutical waste streams
Mobility: Readily soluble and mobile in water; potential for leaching and runoff to surface or groundwater if uncontrolled
Persistence and Degradability: Hydrolyzes in soil or water to ammonia and carbon dioxide, both naturally occurring and rapidly utilized by the environment
Bioaccumulation: No expected bioaccumulation in aquatic or terrestrial organisms
Other Effects: In excess, can contribute to eutrophication of water bodies; manage large spills with care
Product Disposal: Small quantities can go to wastewater or solid waste if allowed by local regulations; consult authorities for disposal guidelines in regulated pharmaceutical environments
Packaging Disposal: Rinse and recycle or dispose of packaging in line with regional recycling programs; hazardous residue may require specific treatment
Special Instructions: Do not flush large amounts into surface waters, sewers, or natural environments without approval; use licensed waste contractors for industrial-size disposals
Regulatory Compliance: Adhere to local and national disposal standards, including hazardous and non-hazardous pharmaceutical waste rules
UN Number: Not regulated for transport as it is non-hazardous
Shipping Name: Urea, Pharmaceutical Grade
Transport Hazard Class: Not classified as dangerous for road (ADR), air (IATA), or sea (IMDG) transport
Packing Group: Not applicable due to low risk
Special Precautions: Use sealed, sturdy packaging to prevent moisture uptake or contamination; keep away from incompatible products during transport
Label Requirements: General pharmaceutical or chemical labeling as per content and jurisdiction
Regulatory Status: Approved for use in pharmaceutical and personal care product manufacturing; listed in main pharmacopoeias (USP, EP, JP)
OSHA Status: Not listed as a hazardous substance
TSCA/REACH: Registered and compliant under TSCA (USA) and REACH (EU); check batch compliance certificates
FDA Status: Recognized as an inactive ingredient for drugs and topical products
WHMIS Classification: Not controlled under Canadian WHMIS legislation
Labeling Details: Must display composition, purity, batch, and supplier information as per national and international pharmaceutical transport regulations
