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Product Name: Escitalopram Oxalate
Synonyms: S-citalopram oxalate, (S)-1-[3-(dimethylamino)propyl]-1-(4-fluorophenyl)-1,3-dihydroisobenzofuran-5-carbonitrile oxalate
Chemical Family: Selective serotonin reuptake inhibitor (SSRI)
CAS Number: 219861-08-2
Intended Use: Active pharmaceutical ingredient used for the treatment of depression and anxiety disorders.
Supplier Details: Name, address, emergency contact phone numbers specific to the distributor or manufacturer.
Classification: Harmful if swallowed; may cause respiratory irritation. May cause eye and skin irritation. Not considered carcinogenic by IARC. Toxicological effects include neurotoxicity and effects on serotonin balance.
Signal Word: Warning
Pictograms: Exclamation mark (for acute toxicity and other health hazards)
Hazard Statements: Harmful if swallowed or inhaled. Causes skin and eye irritation. May cause allergic reactions in sensitive individuals.
Precautionary Statements: Avoid inhalation, ingestion, and contact with skin or eyes. Always use in a well-ventilated area with proper personal protection.
Other Hazards: May interfere with neurotransmitter levels if absorbed or ingested. Accidental release may cause environmental contamination.
Chemical Name: Escitalopram Oxalate
CAS Number: 219861-08-2
Concentration: ≥ 98% purity as supplied for pharmaceutical manufacturing
Impurities: Trace by-products from synthesis—typically below reporting threshold, but may include related SSRIs
Other Ingredients: No additives or excipients in raw material; processed material may contain stabilizers or binders if specified for tableting.
Inhalation: Move to fresh air immediately; keep airway open. If symptoms persist such as dizziness, headache, or nausea, seek physician evaluation.
Skin Contact: Wash thoroughly with soap and water. Remove contaminated clothing and launder before reuse. If irritation develops, contact medical personnel.
Eye Contact: Rinse cautiously with water for at least 15 minutes. Hold eyelids open, flush thoroughly, remove contact lenses if present. If irritation continues, consult an eye specialist.
Ingestion: Rinse mouth with water. Do not induce vomiting without medical advice. Seek immediate medical help, particularly if large quantities or symptoms appear.
Symptoms and Effects: May include nausea, dizziness, agitation, or allergic skin reactions. Effects on central nervous system possible depending on dose.
Extinguishing Media: Use water spray, dry chemical, carbon dioxide, or foam. Avoid high-pressure water jets that could spread material.
Special Hazards: Combustion may produce toxic fumes such as nitrogen oxides, carbon monoxide, carbon dioxide, and hydrogen fluoride.
Protective Equipment: Firefighters should wear self-contained breathing apparatus and full protective clothing. Avoid inhaling smoke or vapors.
Advice: Contain runoff to prevent environmental contamination. Remove unaffected containers from area if safe to do so.
Personal Precautions: Evacuate unnecessary personnel. Use appropriate PPE including gloves, goggles, respiratory protection if dust is present.
Methods for Cleanup: Collect spill with absorbent material (vermiculite, sand). Sweep or scoop for disposal in a sealed container. Clean area with detergent and water.
Environmental Precautions: Prevent entry into drains, watercourses, or soil. Any release in a laboratory or controlled environment should be managed per hazardous waste protocols.
Spill Response: Trained personnel only. Ensure adequate ventilation during cleanup, avoid dust generation.
Handling: Handle in accordance with good industrial hygiene and safety practice. Use local exhaust ventilation to minimize airborne dust. Avoid breathing dust and direct contact with skin or eyes. Employees working with bulk material must wear gloves, lab coat, and safety eyewear. Wash hands after handling.
Storage: Store in tightly closed, labeled containers in a cool, dry, well-ventilated place. Protect from light and incompatible substances such as acids and oxidizers. Segregate from general storage to reduce risk of exposure and cross-contamination.
Special Considerations: Keep out of reach of unauthorized persons. Do not store with food or beverage items. Repackage only in proper containers using safety equipment.
Exposure Limits: No specific occupational exposure limits established. As a pharmaceutical agent, use best practice protocols for occupational safety.
Engineering Controls: Local exhaust ventilation recommended when handling powders. Closed systems or barrier technologies preferred in production facilities.
Personal Protection: Chemical-resistant gloves (nitrile or similar), laboratory coat, safety goggles, and, for airborne dust, NIOSH-approved particulate respirator. In bulk processing, use handling enclosures with HEPA filters. Wash hands after use and before eating or smoking.
Environmental Controls: Use systems to prevent dust release. Collect process waste and spills for safe disposal.
Appearance: White to off-white crystalline powder
Odor: Odorless
pH (1% solution): Not available
Melting Point: 150 °C – 155 °C (decomposes)
Boiling Point: Decomposes before boiling
Solubility: Freely soluble in methanol, slightly soluble in water, ethanol
Density: Approximately 1.3 g/cm³
Partition Coefficient (log P): 0.81 (as escitalopram)
Vapor Pressure: Not volatile at room temperature
Molecular Formula: C20H21FN2O•C2H2O4
Molecular Weight: 414.43 g/mol
Chemical Stability: Stable under normal laboratory and storage conditions; sensitive to light and moisture over time.
Reactivity: Nonreactive under recommended use conditions. Avoid strong acids, bases, and oxidizing agents.
Decomposition Products: Burning material releases hazardous gases such as carbon monoxide, carbon dioxide, hydrogen fluoride, and nitrogen oxides.
Hazardous Reactions: No data for polymerization or violent decomposition under ambient conditions, but avoid mixing with incompatible materials.
Likely Routes of Exposure: Inhalation, ingestion, skin, and eye contact
Acute Toxicity: Oral LD50 (rat): 375 mg/kg
Chronic Effects: Long-term exposure can affect serotonin regulation, may trigger allergic or hypersensitivity reactions, and has potential for neurotoxicity above therapeutic levels.
Symptoms from Exposure: Dizziness, nausea, restlessness, skin rash, or eye redness.
Carcinogenicity: Not listed by IARC, NTP, or OSHA.
Reproductive Toxicity: Studies indicate risk to fetal development in high, repeated doses not reflective of therapeutic use.
Ecotoxicity: Toxic to aquatic organisms even in low concentrations. May cause long-term adverse effects in the aquatic environment if not properly contained or disposed.
Persistence and Degradability: Relatively persistent in the natural environment, slow biodegradation through standard wastewater treatment.
Bioaccumulation Potential: Low to moderate; main metabolite is water-soluble and excreted by humans.
Mobility in Soil: Mobile in water-rich soils, possible leaching to groundwater if released.
Other Effects: Pharmaceuticals in the environment may disrupt aquatic fauna behavior or reproduction.
Waste Disposal Method: Incinerate using properly permitted facility. Do not discharge to surface water or routine sewage systems.
Contaminated Packaging: Dispose as hazardous waste. Rinse containers and avoid reuse for non-pharmaceutical materials.
Special Instructions: Manage all waste in accordance with national and local regulations. Document all waste streams for tracking and audit in accordance with Good Manufacturing Practice guidelines.
Unused Material: Return to supplier or dispose via licensed hazardous waste contractor.
UN Number: Not regulated as dangerous goods by transport agencies for most finished dosages; bulk powder may require classification.
Shipping Name: Escitalopram Oxalate
Transport Hazard Class: Not classified as hazardous for land, air, or sea under most local transportation codes.
Packing Group: Not applicable
Special Precautions: Ship in sealed primary packaging to prevent damage and exposure. Protect from moisture, sunlight, and rough handling.
Environmental Hazards: Take measures to prevent accidental release during loading, unloading, or transport.
OSHA Status: Not specifically regulated, but considered a hazardous chemical by criteria for occupational health.
TSCA (Toxic Substances Control Act): Not listed for commercial distribution.
REACH Registration: Required only for tonnage thresholds in EU production, generally not registered for downstream pharmaceutical use.
SARA Title III: Not subject to reporting requirements for typical pharmaceutical manufacturing, unless stored above threshold planning quantities.
Other Regulations: Controlled substances or prescription drug scheduling applies in some jurisdictions. All manufacturing and handling must comply with GMP and relevant pharmaceutical quality standards.
Labeling Requirements: Label product and secondary containers with hazard warnings and handling advisories as per local regulations.
