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Product Name: Duloxetine Hydrochloride
Chemical Name: (+)-(S)-N-methyl-3-(1-naphthyloxy)-3-(thiophen-2-yl)propan-1-amine Hydrochloride
CAS Number: 136434-34-9
Molecular Formula: C18H19NOS • HCl
Molecular Weight: 333.87 g/mol
Recommended Use: Active pharmaceutical ingredient in the treatment of major depressive disorder and neuropathic pain
Synonyms: Duloxetine HCl, Cymbalta (as a drug product)
Supplier Details: Manufacturer’s physical address, emergency contact number, and business phone number appear on product label for proper traceability and shipment clarification
GHS Classification: Acute Toxicity (Oral) Category 4, Eye Irritation Category 2A, Specific Target Organ Toxicity (Single Exposure) Category 3
Signal Word: Warning
Hazard Statements: May cause irritation to eyes, respiratory system, or skin. Toxic if swallowed in large quantities. Possible danger to aquatic life.
Pictograms: Exclamation mark symbol
Precautionary Statements: Avoid breathing dust. Wear protective gloves and safety goggles. Wash hands thoroughly after handling. Do not eat, drink, or smoke while working with this compound. Dispose only in compliance with national and local regulations.
Substance: Duloxetine Hydrochloride
Concentration: >98% by weight
Impurities: May contain low levels of process-related and degradation impurities, typically below 1% each
Other Components: No stabilizers, solvents, or additional agents are present in the raw API
Inhalation: Move affected person to fresh air quickly. If symptoms like respiratory irritation persist, seek medical attention and provide oxygen if breathing becomes difficult.
Skin Contact: Rinse skin immediately with plenty of water and mild soap. Remove contaminated clothes and wash thoroughly. Get medical help in case of persistent irritation or allergic reaction.
Eye Contact: Rinse eyes gently with running water for at least 15 minutes. Hold eyelids apart to ensure thorough rinse. Immediate medical attention is necessary if irritation or sensitivity continues.
Ingestion: Rinse out mouth with water, but do not induce vomiting. Drink water as tolerated. Seek medical assistance immediately due to potential toxicity.
Suitable Extinguishing Media: Dry chemical, carbon dioxide, water spray (mist), or alcohol-resistant foam
Unsuitable Extinguishing Media: Direct water jet, which may spread powder and create additional hazards
Specific Hazards: Product decomposes upon combustion and can produce hazardous vapors such as nitrogen oxides, sulfur oxides, hydrogen chloride, and carbon monoxide
Protective Equipment for Firefighters: Wear full protective clothing and self-contained breathing apparatus to guard against inhalation of combustion fumes
Firefighting Instructions: Use water spray to cool containers. Avoid inhaling smoke or dust. Remove personnel from immediate area if not involved in firefighting
Personal Precautions: Evacuate unnecessary personnel from spill zone. Wear disposable gloves, goggles, and an appropriate dust mask or respiratory protection. Minimize dust generation and ensure adequate ventilation.
Environmental Precautions: Prevent product from entering waterways, drains, and soil. Report substantial releases to environmental or health authorities as required by regulations.
Clean-up Methods: Collect spilled powder with appropriate tools such as a vacuum with HEPA filter or damp absorbent material. Place residue in closed containers for recovery or disposal. Wash spill area with suitable detergent and water, avoiding formation of dust clouds.
Handling: Wear lab coat, nitrile gloves, and chemical splash goggles during manipulation. Use powder in certified chemical fume hood or with local exhaust ventilation. Clean work areas regularly and decontaminate surfaces after each use. Keep containers tightly closed when not in use to prevent moisture absorption or contamination.
Storage: Store chemical in original container within cool, dry, well-ventilated, and secured area. Avoid prolonged exposure to light, excessive heat, humidity, and incompatible chemicals. Keep away from food, beverages, and animal feed. Retain security seals for traceability, and record lot and batch information in regulatory documentation.
Occupational Exposure Limit: No specific OSHA or ACGIH exposure limit for duloxetine hydrochloride, though safe work practice dictates use of pharmaceutical occupational exposure banding (typically band 3, <10 μg/m³ air as inhalable dust)
Engineering Controls: Laboratory chemical fume hood, local exhaust, and HEPA filtration to capture airborne powder
Personal Protective Equipment: Safety glasses with side shields, disposable gloves (nitrile or latex), laboratory coat, and certified disposable mask (N95 or equivalent for dust). Use fitted half- or full-face respirators if powder concentrations are high.
Hygiene Measures: Wash hands, forearms, and face after handling material; avoid contact with mouth, nose, and skin. Remove protective equipment only after thorough washing.
Appearance: Off-white to slightly yellow crystalline powder
Odor: Practically odorless
pH (aqueous solution): Approximately 5.0 - 7.0 (1% w/v in water)
Boiling Point: Decomposes before boiling
Melting Point: Around 138 - 143°C
Solubility: Freely soluble in water, methanol, and ethanol; slightly soluble in isopropanol; insoluble in some organic solvents
Partition Coefficient (log P): Approximately 4.2 (octanol/water)
Vapor Pressure: Not determined for solid
Density: Not specified in primary sources
Flash Point: Not applicable; material is solid
Other Data: Stable under ambient conditions but sensitive to moisture and elevated temperature
Chemical Stability: Stable under recommended storage conditions, minor degradation possible with heat, light, or exposure to acidic/basic environments
Reactivity: No hazardous polymerization expected, reacts with strong oxidizers, acids, and bases
Conditions to Avoid: Excess moisture, high temperature, direct sunlight, and incompatible chemical agents
Hazardous Decomposition Products: Nitrogen oxides, sulfur oxides, hydrogen chloride gas, and other toxic vapors may develop upon thermal decomposition or fire
Routes of Exposure: Inhalation, ingestion, contact with skin, contact with eyes
Acute Toxicity: LD50 (rat, oral) approximately 500 mg/kg; higher doses can cause drowsiness, nausea, vomiting, agitation, muscular twitching, tremors, or cardiovascular effects
Chronic Toxicity: Prolonged exposure may provoke neuropsychiatric or hepatic effects
Carcinogenicity, Mutagenicity, Teratogenicity: No evidence for carcinogenesis in standard assays; not found mutagenic or clastogenic; animal studies show no clear teratogenic signal at therapeutic exposures
Other Health Hazards: Allergic reactions and contact sensitization have been observed in susceptible individuals working with duloxetine and related molecules
Ecotoxicity: Demonstrates moderate toxicity to aquatic organisms; LC50/EC50 aquatic values typically in low mg/L range for fish and daphnia
Persistence and Degradability: Partially biodegradable, persistent in aqueous environments with possible long-term impact on aquatic species
Bioaccumulative Potential: High log P value indicates potential for accumulation in aquatic species tissues
Mobility in Soil: Moderate soil binding, traceable leaching possible through soil and water
Other Environmental Hazards: Avoid introduction into groundwater, surface water, and sewage systems due to uncertainty around chronic ecological effects
Product Disposal: Dispose of waste and residues as hazardous chemical waste in accordance with national and local environmental regulations. Collect product and contaminated packaging in secure, labeled containers. Use approved chemical waste incinerator for treatment and disposal.
Contaminated Packaging: Decontaminate or incinerate empty packaging in approved facilities. Label discarded containers clearly for hazardous waste handlers.
Environmental Precautions: Prevent significant releases to air, water, or soil. Never dispose of via household drains, municipal sewers, or regular landfill waste streams.
UN Number: Not regulated as a dangerous good for land transport (ADR/RID), marine transport (IMDG), or air transport (IATA)
Proper Shipping Name: Duloxetine Hydrochloride, pharmaceutical ingredient
Transport Hazard Class: Not classified as hazardous for transport under ADR/IMDG/IATA guidelines
Packing Group: Not assigned
Special Transport Precautions: Transport in tightly sealed containers, shielded from direct sun, physical damage, moisture, and incompatible loads. Secure documentation and batch tracking must accompany each shipment, especially for international transfer.
EU Regulations: REACH registration not mandatory for pharmaceutical intermediates; not listed on SVHC candidate list. Subject to local workplace and environmental health legislation.
US Regulations: Not listed on the US TSCA Inventory. Not regulated as a hazardous substance under CERCLA, EPCRA, or SARA Title III
Other Regional Compliance: Complies with applicable pharmacopoeial monographs including USP, EP, JP where produced and marketed. Follow local requirements for safe handling, waste, industrial hygiene, and environmental protection.
Labeling Requirements: GHS-compliant hazard and precautionary statements must appear on all packaging, with traceable lot number and supplier contact.
