© 2026 Sinochem Nanjing Corporation,
All Right Reserved
Product Name: Loratadine
Chemical Name: Ethyl 4-(8-chloro-5,6-dihydro-11H-benzo[5,6]cyclohepta[1,2-b]pyridin-11-ylidene)piperidine-1-carboxylate
Synonyms: Claritin, Alavert
Recommended Uses: Antihistamine for allergy relief
Manufacturer Information: Available from various pharmaceutical companies
Emergency Phone Number: Provided by supplier upon request
CAS Number: 79794-75-5
GHS Classification: Not classified as hazardous under GHS
Acute Health Hazards: May cause mild irritation to eyes and skin in powder form. Ingestion of large amounts can provoke drowsiness, headache, and rapid heart rate.
Chronic Health Hazards: No known long-term health hazards based on animal studies.
Physical Hazards: As fine powder, can pose a dust explosion risk if dispersed in air.
Signal Word: None required
Symbols: None
Precautionary Statements: Avoid dust and direct contact with eyes and skin.
Chemical Composition: Pure active ingredient, Loratadine (C22H23ClN2O2)
Concentration: 100% for raw material, typical finished dosage contains 10mg per tablet
Impurities: Technical grade specifications limit related substances to low ppm levels
Additives (in tablet form): Lactose, microcrystalline cellulose, corn starch, magnesium stearate, talc – not present in raw Loratadine API
CAS Registry Number: 79794-75-5
Eye Contact: Rinse cautiously with water for several minutes. Remove contact lenses if easy and continue rinsing. Seek medical attention if irritation persists.
Skin Contact: Wash with plenty of water and soap. Remove contaminated clothing.
Inhalation: Move person outdoors or to well-ventilated area. Get medical advice if symptoms like coughing or shortness of breath develop.
Ingestion: Rinse mouth with water. Do not induce vomiting unless advised by medical personnel. Get medical help if large quantities ingested or symptoms occur.
Note to Physician: Provide symptomatic and supportive treatment. There is no specific antidote.
Suitable Extinguishing Media: Dry chemical powder, foam, carbon dioxide, water spray
Hazardous Decomposition Products: Carbon monoxide, carbon dioxide, nitrogen oxides, hydrochloric acid fumes possible
Fire/Explosion Hazards: Dust may form explosive mixtures with air under severe conditions
Special Protective Equipment: Firefighters should wear full protective clothing and self-contained breathing apparatus
Fire Fighting Instructions: Avoid breathing smoke or fumes. Use standard firefighting measures for pharmaceutical powders. Prevent run-off from fire control from entering drains.
Personal Precautions: Use protective clothing, gloves, eye protection, and breathing apparatus if dust is generated
Environmental Precautions: Prevent further leakage or spillage. Keep away from drains, surface waters, and soil
Clean-Up Methods: Collect spillage with non-sparking tools. Use dust-collecting procedures, place in sealable, labeled containers for disposal. Flush area with water after clean-up if appropriate.
Handling: Avoid generating dust. Use proper ventilation. Do not eat, drink, or smoke near the product. Wash hands and exposed skin thoroughly after handling.
Storage Conditions: Keep container tightly closed in a cool, dry, well-ventilated place away from incompatible materials such as strong oxidizers. Do not store with acids or bases.
Special Storage Requirements: Keep away from direct sunlight, sources of ignition, and excessive humidity. Follow local regulations and workplace safety practices regarding pharmaceutical storage.
Occupational Exposure Limits: No established OSHA or ACGIH limits for Loratadine; use general pharmaceutical exposure practices
Engineering Controls: Implement local exhaust ventilation and use closed handling systems to minimize dust exposure
Personal Protection: Wear chemical safety goggles, lab coat, gloves, and particle-filtering respirator as needed
Hygiene Measures: Avoid contact with skin, eyes, and clothing. Wash hands before breaks and at end of workday.
Environmental Exposure Controls: Use measures to avoid environmental contamination. Collect and dispose of all waste in accordance with regulations.
Appearance: White to off-white crystalline powder
Odor: Odorless or almost odorless
Molecular Formula: C22H23ClN2O2
Molecular Weight: 382.89 g/mol
pH: Not available for pure substance
Melting Point: 134-137°C
Solubility: Practically insoluble in water; freely soluble in acetone, chloroform, methanol
Boiling Point: Not applicable (decomposes before boiling)
Vapor Pressure: Negligible at room temperature
Partition Coefficient (log P): 5.2
Flash Point: Not determined
Autoignition Temperature: Not established
Density: About 1.2 g/cm³ at 20 °C
Other Data: Stable under normal storage conditions
Stability: Stable under recommended handling and storage conditions
Chemical Incompatibilities: Strong oxidizers, acids, bases
Conditions to Avoid: Excess heat, open flames, moisture, direct sunlight
Hazardous Decomposition Products: Thermal decomposition can produce toxic vapors, including oxides of carbon, chlorinated compounds, and nitrogen oxides
Polymerization: Not expected to occur
Acute Toxicity: Oral LD50 in rats reported >5000 mg/kg
Skin Irritation: Mild, based on animal testing
Eye Irritation: Slight to none, depending on concentration
Respiratory Effects: May cause mild discomfort if inhaled in dust form
Chronic Effects: No evidence of mutagenicity, carcinogenicity, or reproductive toxicity in animal studies
Other Health Effects: Overdose can produce drowsiness, tachycardia, headache. Most side effects reversible with discontinuation.
Sensitization: Not reported in studies or clinical use
Environmental Toxicity: Loratadine expected to have low acute toxicity in aquatic organisms (EC50 > 100 mg/L)
Persistence and Degradability: Data limited; suspected moderately biodegradable in standard conditions
Bioaccumulation Potential: Log Kow of 5.2 suggests potential for high bioaccumulation, but real-word data limited
Mobility in Soil: Low water solubility and moderate binding to soil reduce risk of groundwater penetration
Other Information: Proper disposal reduces risk of environmental impact
Product Disposal: Dispose of contents according to local, regional, and national regulations for pharmaceutical waste. Do not discharge into drains or environment.
Container Disposal: Rinse thoroughly before recycling or discarding. Containers may retain product residues; handle as hazardous waste.
Waste Treatment Methods: Incineration in authorized facility preferred for bulk waste; tablets may be processed through pharmaceutical take-back programs if available.
Precautions: Avoid disposing with regular municipal waste or by dumping in the environment.
Recommended Codes: Consult with waste authority for applicable RCRA or local waste code.
UN Number: Not classified as dangerous goods for transport
Transport Hazard Class: Not regulated
Packing Group: None assigned
Maritime Transport (IMDG): Not regulated
Air Transport (IATA/ICAO): Not regulated
Environmental Hazards: Not considered marine pollutant
Special Precautions: Carry in well-closed, labeled containers. Avoid physical damage and moisture during transit.
US Federal Regulations: Not listed as a hazardous substance under SARA Title III, CERCLA, or RCRA
OSHA: Not regulated as a hazardous material
Canada WHMIS Classification: Not classified
EU Regulations: Not classified as a hazardous substance under Regulation EC 1272/2008 (CLP)
Other Regulatory Standards: Listed in pharmacopeias (USP, EP); approval as API by US FDA and EMA
Inventory Status: Listed on TSCA Inventory for research; fully approved for pharmaceutical use.
