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Section 1. Chemical Product and Company Identification
    Levothyroxine Sodium Hydrate        Catalog    
    T1281, T1432, T3183
    Common Name/
    Number(s).
    Trade Name
    CAS#        25416-65-3; 55-03-8    
    (anhydrous CAS number)
    Manufacturer
    Commercial Name(s)
    Levothyroxine Sodium Hydrate

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Section 3. Hazards Identification
    Potential Acute Health Effects Slightly hazardous in case of skin contact (irritant), of eye contact (irritant), of ingestion, of inhalation.
    Potential Chronic Health        CARCINOGENIC EFFECTS: Not available.    
    Effects        MUTAGENIC EFFECTS: Not available.    
    TERATOGENIC EFFECTS: Not available.
    DEVELOPMENTAL TOXICITY: Not available.
    Repeated or prolonged exposure is not known to aggravate medical condition.

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Section 4. First Aid Measures
    Eye Contact        Check for and remove any contact lenses. In case of contact, immediately flush eyes with plenty of water for at    
    least 15 minutes. Get medical attention.
    Skin Contact        In case of contact, immediately flush skin with plenty of water. Cover the irritated skin with an emollient. Remove    
    contaminated clothing and shoes. Wash clothing before reuse. Thoroughly clean shoes before reuse. Get
    medical attention.
    Serious Skin Contact        Wash with a disinfectant soap and cover the contaminated skin with an anti-bacterial cream. Seek medical    
    attention.
    Inhalation        If inhaled, remove to fresh air. If not breathing, give artificial respiration. If breathing is difficult, give oxygen. Get    
    medical attention.
    Serious Inhalation        Not available.    
    Ingestion
    Do NOT induce vomiting unless directed to do so by medical personnel. Never give anything by mouth to an
    unconscious person. If large quantities of this material are swallowed, call a physician immediately. Loosen tight
    clothing such as a collar, tie, belt or waistband.
    Serious Ingestion        Not available.    

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Section 5. Fire and Explosion Data
    Flammability of the Product May be combustible at high temperature.
    Auto-Ignition Temperature Not available.
    Flash Points        Not available.    
    Flammable Limits        Not available.    
    Products of Combustion        These products are carbon oxides (CO, CO2), nitrogen oxides (NO, NO2...). Some metallic oxides.    
    Fire Hazards in Presence of Slightly flammable to flammable in presence of open flames and sparks, of heat.
    Various Substances        Non-flammable in presence of shocks.    
    Explosion Hazards in Presence Risks of explosion of the product in presence of mechanical impact: Not available.
    of Various Substances        Risks of explosion of the product in presence of static discharge: Not available.    
    Fire Fighting Media        SMALL FIRE: Use DRY chemical powder.    
    and Instructions        LARGE FIRE: Use water spray, fog or foam. Do not use water jet.    
    Special Remarks on        Not available.    
    Fire Hazards
    Special Remarks on Explosion Not available.
    Hazards
    Levothyroxine Sodium Hydrate

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Section 6. Accidental Release Measures
    Small Spill        Use appropriate tools to put the spilled solid in a convenient waste disposal container. Finish cleaning by    
    spreading water on the contaminated surface and dispose of according to local and regional authority
    requirements.
    Large Spill        Use a shovel to put the material into a convenient waste disposal container. Finish cleaning by spreading water    
    on the contaminated surface and allow to evacuate through the sanitary system.

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Section 7. Handling and Storage
    Precautions        Keep away from heat. Keep away from sources of ignition. Ground all equipment containing material. Do not    
    breathe dust. Wear suitable protective clothing. In case of insufficient ventilation, wear suitable respiratory
    equipment. If you feel unwell, seek medical attention and show the label when possible. Avoid contact with skin
    and eyes.
    Keep container tightly closed. Keep container in a cool, well-ventilated area. Do not store above 8°C (46.4°F).
    Storage
    Refrigerate. Sensitive to light. Store in light-resistant containers.

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Section 8. Exposure Controls/Personal Protection
    Engineering Controls        Use process enclosures, local exhaust ventilation, or other engineering controls to keep airborne levels below    
    recommended exposure limits. If user operations generate dust, fume or mist, use ventilation to keep exposure to
    airborne contaminants below the exposure limit.
    Personal Protection        Safety glasses. Lab coat. Dust respirator. Be sure to use an approved/certified respirator or equivalent. Gloves.    
    Personal Protection in Case of Splash goggles. Full suit. Dust respirator. Boots. Gloves. A self contained breathing apparatus should be used
    a Large Spill        to avoid inhalation of the product. Suggested protective clothing might not be sufficient; consult a specialist    
    BEFORE handling this product.
    Exposure Limits        Not available.    

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Section 9. Physical and Chemical Properties
    Physical state and appearance Solid. (crystalline powder. Powdered solid.)        Odor        Odorless.    
    Not available.
    Taste
    Molecular Weight        798.86 g/mole + xH2O    
    Off-white. White to yellowish.
    Color
    Not available.
    pH (1% soln/water)
    Boiling Point        Not available.    
    Decomposition temperature: 207°C (404.6°F) - 210 C.
    Melting Point
    Critical Temperature        Not available.    
    Specific Gravity        Not available.    
    Not applicable.
    Vapor Pressure
    Vapor Density        Not available.    
    Not available.
    Volatility
    Odor Threshold        Not available.    
    Water/Oil Dist. Coeff.        Not available.    
    Ionicity (in Water)        Not available.    
    Dispersion Properties        Not available.    
    Solubility        Partially soluble in cold water.    
    Solubilitiy in Water: 0.15 g/l @ 25 C.
    Levothyroxine Sodium Hydrate

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Section 10. Stability and Reactivity Data
    The product is stable.
    Stability
    Instability Temperature        Not available.    
    Excess heat, incompatible materials, light
    Conditions of Instability
    Not available.
    Incompatibility with various
    substances
    Corrosivity        Not available.    
    Special Remarks on        Light Sensitive    
    Reactivity
    Special Remarks on        Not available.    
    Corrosivity
    Polymerization        Will not occur.    

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Section 11. Toxicological Information
    Routes of Entry        Inhalation. Ingestion.    
    Toxicity to Animals        LD50: Not available.    
    LC50: Not available.
    Chronic Effects on Humans Not available.
    Other Toxic Effects on        Slightly hazardous in case of skin contact (irritant), of ingestion, of inhalation.    
    Humans
    Special Remarks on        Not available.    
    Toxicity to Animals
    Special Remarks on        May cause adverse reproductive effects (Maternal effects on fertility, fetotoxicity) based on animal data.    
    Chronic Effects on Humans
    Special Remarks on other        Acute Potential Health Effects;    
    Toxic Effects on Humans        Skin: May cause skin irritation.    
    Eyes: May cause eye irritation by mechanical action.
    Inhalation: May cause respiratory tract irritation.
    Ingestion: May cause digestive tract irritation. May affect metabolism, thyroid, urinary sytem, behavior
    (excitement, headache, coma), cardiovascular system (increased pulse rate),

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Section 12. Ecological Information
    Ecotoxicity        Not available.    
    Not available.
    BOD5 and COD
    Possibly hazardous short term degradation products are not likely. However, long term degradation products may
    Products of Biodegradation
    arise.
    Toxicity of the Products        The product itself and its products of degradation are not toxic.    
    of Biodegradation
    Not available.
    Special Remarks on the
    Products of Biodegradation
    Levothyroxine Sodium Hydrate

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Section 13. Disposal Considerations
    Waste Disposal        Waste must be disposed of in accordance with federal, state and local environmental    
    control regulations.

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Section 14. Transport Information
    DOT Classification        Not a DOT controlled material (United States).    
    Not applicable.
    Identification
    Not applicable.
    Special Provisions for
    Transport
    DOT (Pictograms)

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Section 15. Other Regulatory Information and Pictograms
    No products were found.
    Federal and State
    Regulations
    California        California prop. 65: This product contains the following ingredients for which the State of California has found    
    to cause cancer which would require a warning under the statute: No products were found.
    Proposition 65
    Warnings
    California prop. 65: This product contains the following ingredients for which the State of California has found
    to cause birth defects which would require a warning under the statute: No products were found.
    Other Regulations        Not available.    
    Other Classifications        WHMIS (Canada) Not controlled under WHMIS (Canada).    
    DSCL (EEC)        This product is not classified according S24/25- Avoid contact with skin and eyes.    
    to the EU regulations.
    Health Hazard
    HMIS (U.S.A.)        1 National Fire Protection    
    1 Flammability
    1 Association (U.S.A.)
    Fire Hazard
    1 0 Reactivity
    Health
    Reactivity
    0
    Specific hazard
    Personal Protection
    E
    WHMIS (Canada)
    (Pictograms)
    DSCL (Europe)
    (Pictograms)
    TDG (Canada)
    (Pictograms)
    Levothyroxine Sodium Hydrate
    ADR (Europe)
    (Pictograms)
    Protective Equipment
    Gloves.
    Lab coat.
    Dust respirator. Be sure to use an
    approved/certified respirator or
    equivalent.

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SECTION 16 - ADDITIONAL INFORMATION
N/A