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Product Name: L-Thyroxine
Chemical Name: Levothyroxine sodium
CAS Number: 55-03-8
Manufacturer: Pharmaceutical supplier information available on package insert
Use: Thyroid hormone replacement therapy
Synonyms: 3,5,3',5'-Tetraiodo-L-thyronine sodium salt, T4
Contact Information: Emergency contact listed by manufacturer, refer to local poison control for region-specific support and medical advice.
Classification: Not classified as hazardous per OSHA or EU guidelines in therapeutic form, but pure API can cause harm if inhaled, swallowed, or through skin contact
Routes of Exposure: Inhalation, ingestion, skin and eye contact
Potential Health Effects: May cause headache, irritability, increased heart rate, sweating, chest pain if mishandled; known effects at therapeutic overdose include arrhythmia and anxiety
Emergency Overview: White to off-white powder, odourless; avoid dust, prevent contact with eyes and skin
Label Elements: Not packed with pictograms in most clinical settings, but hazard statements recommend use of PPE in industrial settings
Main Ingredient: L-Thyroxine sodium salt (>99%)
Impurities: Inorganic salts & trace by-products below pharmaceutical regulatory limits
Excipient Presence: In formulated tablets, bulking agents like lactose and stearic acid may be included; excipients vary by manufacturer
Molecular Formula: C15H10I4NNaO4
Molecular Weight: 798.86 g/mol
Concentration: Bulk API or tablet content specified by finished product insert
Inhalation: Move person to fresh air, keep airways open; seek immediate medical advice after exposure to dust or powder
Ingestion: Do not induce vomiting; rinse mouth, drink water if conscious, rapid medical help is needed due to risk of acute toxicity
Skin Contact: Remove contaminated clothing, wash skin thoroughly with soap and water
Eye Contact: Flush gently with plenty of water for at least 15 minutes, lifting eyelids; medical help is required especially after direct powder exposure
Medical Providers: Advise them of nature of compound, symptomatic treatment, monitor heart rate and blood pressure
Suitable Extinguishing Media: Dry chemical powder, carbon dioxide, alcohol-resistant foam, water spray
Combustion Hazards: Emits toxic fumes including iodine and oxides of carbon, nitrogen when burned
Firefighting Instructions: Trained personnel should wear self-contained breathing apparatus and full protective gear
Explosion Sensitivity: Not considered highly explosive, but dust can pose minor ignition hazards
Special Hazards: Avoid inhaling combustion products; evacuate area beyond immediate fire zone when large amounts involved
Personal Precautions: Use face mask, chemical-resistant gloves, lab coat; limit exposure, ventilate area
Environmental Precautions: Prevent run-off to sewers; contain spills and avoid powder dispersion
Cleanup Methods: Carefully collect spilled material using filter vacuum or damp cloth; do not create dust; store waste in sealed, labeled containers for regulated disposal
Discharge Protection: Secure area, alert environmental protection if mass spillage occurs
Handling: Avoid breathing dust, prevent skin and eye contact; use in well-ventilated areas, employ engineering controls, keep containers tightly closed
Storage: Store under cool, dry conditions away from light and moisture; maintain proper labeling; keep away from incompatible chemicals such as strong acids or oxidizers; shelf-life is maintained if stored at recommended temperature
Packaging: Original, tamper-evident containers, keep securely closed between uses
Incompatibilities: Store separately from substances that may react with thyroid hormones
Engineering Controls: Fume hood or local exhaust ventilation recommended in large-scale settings
Personal Protective Equipment: Nitrile gloves, protective lab goggles, lab coat; for bulk handling, use disposable suit and respirators as appropriate
Exposure Limits: Not assigned by OSHA or ACGIH, minimize exposure as L-Thyroxine acts pharmacologically at very low concentrations
Hygiene Measures: Wash hands thoroughly after handling, avoid eating, drinking or smoking in work area
Appearance: White to almost white crystalline powder
Odor: Odorless
Boiling Point: Decomposes before boiling
Melting Point: 230–234°C
Solubility: Slightly soluble in water, more soluble in alkaline conditions
pH: Neutral in deionized water suspension
Vapor Pressure: Not applicable, negligible at ambient temperature
Partition Coefficient: logP ~2.6
Stability: Stable at standard temperature and pressure with adequate storage
Chemical Stability: Stable under recommended storage, breaks down under strong light or heat
Reactivity: Low under normal handling; avoid strong oxidizers and acids
Hazardous Decomposition: Releases noxious gases of iodine, nitrogen oxides, sodium oxides if burned or heated strongly
Polymerization: Will not occur
Conditions to Avoid: Extreme temperatures, direct sunlight, incompatible storage conditions
Acute Toxicity: Oral LD50 in rat is approximately 1000 mg/kg; lower thresholds for humans if ingested in excess
Chronic Effects: Prolonged exposure may cause thyrotoxicosis symptoms—palpitations, anxiety, insomnia, weight loss
Carcinogenicity: Not identified as carcinogen by IARC, NTP, or OSHA
Mutagenicity & Reproductive Effects: No evidence of significant risk at clinical doses; animal studies show limited reproductive effects at high exposures
Sensitization: Rare reports of skin or respiratory sensitivity, usually related to excipients
Ecotoxicity: May pose a risk to aquatic organisms due to endocrine disruption at high concentrations in water supplies
Persistence and Degradability: Slowly biodegradable; breaks down under sunlight and microbial action
Bioaccumulation: Low potential due to environmental degradation pathways
Mobility: May leach to groundwater if large scale release occurs
Other Hazards: Improper disposal could contribute to waterway hormonal contamination
Disposal Methods: Collect waste in rigid, sealed containers labeled for pharmaceutical disposal
Incineration: Recommended under controlled, licensed conditions; do not incinerate with municipal waste
Regulations: Dispose as hazardous pharmaceutical waste per local and national guidelines; avoid release to environment
Unused Material: Return to original supplier for take-back programs if possible
UN Number: Not classified under common transport regulations in small medical quantities
Shipping Name: L-Thyroxine
Transport Hazard Class: Not regulated for ground, air, or sea freight in therapeutic form
Packing Group: Not assigned
Special Precautions: Keep packaging secure, label correctly, protect from physical damage
Environmental Hazards: Not listed as marine pollutant
USA: FDA regulates product as prescription medication; OSHA labeling requirements apply to API in industrial processing
EU: Controlled through EMA/in-country regulatory agencies; REACH registration applies to bulk supply
Workplace Safety: Subject to chemical safety assessments under pharmaceutical manufacturing regulations
Labeling Requirements: GHS not mandated for finished tablets, but required for bulk/industrial chemical
Other Regulations: Requires licensed authorization for purchase and distribution; not scheduled under controlled substances acts but prescription-only
