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Material Safety Data Sheet
Creation Date:  August 12, 2010

1. IDENTIFICATION OF SUBSTANCE:
Trade name: Rivaroxaban
Product Number: R-7199
Manufacturer/Supplier:
LC Laboratories
165 New Boston Street
Woburn, MA 01801 USA
1-781-937-0777 Fax: 1-781-938-5420

2. COMPOSITION/DATA ON COMPONENTS:
Chemical Name: 5-Chloro-N-[[(5S)-2-oxo-3-[4-(3-oxo-4-morpholinyl)phenyl]-5-oxazolidinyl]methyl]-2-thiophenecarboxamide
Synonyms: BAY-59-7939, D07086, Xarelto
Hazardous Ingredient: Rivaroxaban
CAS Registry Number: 366789-02-8
Molecular Weight: 435.88
Molecular Formula: C19H18ClN3O5S

3. HAZARDS IDENTIFICATION:
Hazard Description: Pharmacologically Active Compound
May be harmful if swallowed or inhaled
Ingestion may cause delayed clotting of blood
In animal studies, rivaroxaban has been shown to cause reproductive toxicity
Exposure may cause irritation to eyes, mucous membranes, upper respiratory tract, and skin

4. FIRST AID MEASURES:
After Inhalation: If inhaled, remove to fresh air; if breathing is difficult, give oxygen; if breathing stops, give artificial respiration
After skin contact: flush with copious amounts of water; remove contaminated clothing and shoes; call a physician
After eye contact: check for and remove contact lenses; flush with copious amounts of water; assure adequate flushing by separating the eyelids with fingers; call a physician
After swallowing: if swallowed, wash out mouth with copious amounts of water; call a physician

5. FIRE FIGHTING MEASURES:
Suitable extinguishing agents: water spray, carbon dioxide, dry chemical powder or foam
Protective equipment: wear self-contained breathing apparatus and protective clothing to prevent contact with skin and eyes.
Unusual fire hazard: may emit toxic fumes under fire conditions such as carbon monoxide, etc.

6. ACCIDENTAL RELEASE MEASURES:
Person-related safety precautions: cordon off area of spill; wear self-contained breathing apparatus, protective clothing and heavy rubber gloves
Measures for cleaning/collecting: absorb solutions with finely- powdered liquid-binding material (diatomite, universal binders); decontaminate surfaces and equipment by scrubbing with alcohol; dispose of contaminated material according to Section 13

7. HANDLING AND STORAGE:
Information for safe handling: avoid contact with skin, eyes and clothing; material may be an irritant
Storage: store solid and solutions at -20 ºC

8. EXPOSURE CONTROLS AND PERSONAL PROTECTION:
Personal protective equipment as follows:
Breathing equipment: NIOSH/MSHA-approved respirator
Protection of hands: chemical-resistant rubber gloves
Eye protection: chemical safety goggles

9. PHYSICAL AND CHEMICAL PROPERTIES:
Form: crystalline solid; granular or powder
Color: white to off-white
Odor: none
Melting point/Melting range: 218-232 ºC
Danger of explosion: none
Solubility in / Miscibility with water: very poorly soluble in water; maximum solubility in plain water is estimated to be about 20-50 µM; buffers, serum, or other additives may increase or decrease the aqueous solubility
Solvent content:
Organic solvents: soluble in DMSO at 12.5 mg/mL with slight warming; very poorly soluble in ethanol

10. STABILITY AND REACTIVITY:
Stability: avoid acids and bases
Thermal decomposition / conditions to be avoided: protect from light and heat
Dangerous products of decomposition: thermal decomposition may produce toxic gases such as carbon monoxide and carbon dioxide, and nitrogen oxides

11. TOXICOLOGICAL INFORMATION:
RTECS No: not available
Acute toxicity: not known
Primary irritant effect: not known
On the skin: not known; may be an irritant
On the eye: not known; may be an irritant
Inhalation: may be harmful if inhaled
Ingestion: may be harmful if swallowed

12. ECOLOGICAL INFORMATION:
General notes: no data available

13. DISPOSAL CONSIDERATION:
Dispose of in accordance with prevailing country, federal, state and local regulations

14. TRANSPORT INFORMATION:
DOT:
Proper shipping name: none
Non-Hazardous for transport: this substance is considered to be non-hazardous for transport
IATA class:
Proper shipping name: none
Non-Hazardous for transport: this substance is considered to be non-hazardous for transport

15. REGULATIONS:
Code letter and hazard designation of product:
EU Risk And Safety phrases:
S22: Do not breathe dust
S24/25: Avoid contact with skin and eyes
S26: In case of contact with eyes, rinse immediately with plenty of water and seek medical advice
S28: After contact with skin, wash immediately with plenty of water
S36/37/39: Wear protective clothing, gloves and eye/face protection
R20/22: Harmful by inhalation and if swallowed
R36/38: Irritating to eyes and skin

16. OTHER INFORMATION:
The above information is believed to be correct based on our present knowledge but does not purport to be complete. For research use only by trained personnel. The burden of safe use of this material rests entirely with the user. LC Laboratories disclaims all liability for any damage resulting from use of this material.


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