CAS Number 366789-02-8, Rivaroxaban USP BP Ph Eur Grade Manufacturers Exporters
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CAS Number 366789-02-8, Rivaroxaban USP BP Ph Eur Manufacturer Exporter
For Properties Specifications of Rivaroxaban Click Properties, Specifications of Rivaroxaban Manufacturer.
For Uses of Rivaroxaban Click Uses of Rivaroxaban Manufacturer.
For For SDS MSDS Sheet of Rivaroxaban Click SDS Safety Data Sheet MSDS Sheet of Rivaroxaban Manufacturer.
The Properties and Specifications of Rivaroxaban:
Rivaroxaban BP Ph Eur Grade Specifications:
C19H18ClN3O5S --- 435.9 CAS 366789-02-8
Action and use: Factor Xa inhibitor; anticoagulant.
DEFINITION
5-Chloro-N-[[(5S)-2-oxo-3-[4-(3-oxomorpholin-4-yl)phenyl]-1,3-oxazolidin-5-yl]methyl]thiophene-2-carboxamide.
Content: 98.0 per cent to 102.0 per cent (anhydrous substance).
CHARACTERS
Appearance: White or yellowish powder.
Solubility: Practically insoluble in water, freely soluble in dimethyl sulfoxide, practically insoluble in anhydrous ethanol and in heptane.
IDENTIFICATION
A. Infrared absorption spectrophotometry.
B. Enantiomeric purity.
Related substances: to pass the test by liquid chromatography.
Water: Maximum 0.5 per cent, determined on 0.150 g using the evaporation technique at 150C.
Sulfated ash: Maximum 0.1 per cent, determined on 2.0 g.
Rivaroxaban USP Grade Specifications:
C19H18ClN3O5S --- 435.88
2-Thiophenecarboxamide, 5-chloro-N-[[(5S)-2-oxo-3-[4-(3-oxo-4-morpholinyl)phenyl]-5-oxazolidinyl]methyl]-;
5-Chloro-N-({(5S)-2-oxo-3-[4-(3-oxomorpholin-4-yl)phenyl]-1,3-oxazolidin-5-yl}methyl)thiophene-2-carboxamide
CAS: 366789-02-8;
UNII: 9NDF7JZ4M3.
DEFINITION
Rivaroxaban contains NLT 98.0% and NMT 102.0% of rivaroxaban (C19H18ClN3O5S), calculated on the anhydrous basis.
IDENTIFICATION
A. Spectroscopic Identification
B. The retention time of the major peak of the Sample solution corresponds to that of the Standard solution.
Residue on Ignition: NMT 0.1%
Organic Impurities: to pass the test by chromatography.
Water Determination: NMT 1.0%
Packaging and Storage: Preserve in tight, light-resistant containers at controlled room temperature. Keep away from heat and moisture.
The Uses of Rivaroxaban:
Rivaroxaban is an anticoagulant medication (blood thinner) used to treat and prevent blood clots.
The MSDS-SDS Hazard Statement of Rivaroxaban:
Rivaroxaban SDS, Safety Data Sheet
MSDS Sheet, Material Safety Data Sheet 13-Nov-24
1. Product Identification
Product Name/Synonyms: Rivaroxaban.
CAS No.: 366789-02-8
EINECS EC Number: 685-132-2
Relevant uses and uses advised against (if any): Industrial Manufacturing.
Suppliers: As per letterhead.
2. Hazards Identification
GHS, Globally Harmonized System Classification in accordance with 29 CFR 1910
Classification according to Regulation (EC) No 1272/2008
Acute toxicity, oral Category 4
Labeling according to Regulation (EC) No 1272/2008
GHS Label Elements  Irritant |
Signal Words: Warning
Hazard statements:
H302: Harmful if swallowed.
Precautionary statements:
P262: Do not get in eyes, on skin, or on clothing.
P280: Wear protective gloves/protective clothing/eye protection/face protection.
P270: Do not eat, drink or smoke when using this product.
P301+312: IF SWALLOWED: Call a POISON CENTER or doctor/physician if you feel unwell.
P332+313: If skin irritation occurs: Get medical advice/attention.
P302+P352: IF ON SKIN: Wash with plenty of soap and water.
P305+P351+P338: IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing.
P337+P313 If eye irritation persists: Get medical advice/ attention.
3. Composition/Information on Ingredients
Product Name/Synonyms: Rivaroxaban.
CAS No.: 366789-02-8
EINECS EC Number: 685-132-2
4. First Aid Measures
Inhalation:Remove to fresh air. Give oxygen if breathing is difficult; give artificial respiration if breathing has stopped. Keep person warm and quiet; get medical attention.
Ingestion: Induce vomiting immediately as directed by medical personnel. Never give anything by mouth to an unconscious person.
Skin Contact: Immediately flush skin with plenty of soap and water for at least 15 minutes. Remove contaminated clothing and shoes. Wash clothing before reuse. Thoroughly clean shoes before reuse. Get medical attention if irritation develops.
Eye Contact: Immediately flush eyes with plenty of water for at least 15 minutes, lifting upper and lower eyelids occasionally. Get medical attention.
Notes to Physician: Treat symptomatically.
5. Fire Fighting Measures
Fire: It is not considered to be a fire hazard. However, it will burn at high temperature.
Fire Extinguishing Media: Use water spray, alcohol-resistant foam, dry chemical, or carbon dioxide. Use water spray to cool fire-exposed containers. Avoid solid water jet as it can scatter the fire.
Special hazards arising from the substance or mixture: Carbon oxides, Nitrogen oxides (NOx), Sulphur oxides, Chlorine compounds and Fumes.
Special Information: In the event of a fire, wear full protective clothing and NIOSH-approved self-contained breathing apparatus with full face piece.
6. Accidental Release Measures
Personal precautions, protective equipment, and emergency procedures: Use personal protective equipment. Ventilate area of leak or spill. Avoid breathing dust/fumes/gas/mist/vapors/spray. Use individual protective equipment (waterproof boots, suitable protective clothing, safety glasses, etc.).
Environmental precautions: Do not let the product enter drains, soil, or water sources.
Methods and materials used for containment cleanup procedures and Storage: Contain spilled material. Pick up spills and place them in a suitable container for reclamation or disposal.
7. Handling and Storage
Precautions for safe handling: Apply according to good manufacturing and industrial hygiene practices. Ensure proper ventilation. Wear personal protective equipment. Avoid ingestion and inhalation. Wash thoroughly after handling. Do not drink, eat, or smoke while handling. Avoid contact with skin, eyes, and clothing. Avoid breathing dust/fumes/gas/mist/vapors/spray. Keep container tightly closed. Avoid ingestion and inhalation. Use individual protective equipment (waterproof boots, suitable protective clothing, safety glasses, etc.).
Conditions for safe storage, including any incompatibilities: Store in cool, dry, and ventilated area away from heat sources and protected from sunlight in tightly closed original container. Keep air contact to a minimum. Do not leave the material container open. Store protected from heat, sparks and ignition sources and incompatible materials. Avoid inhalation of dust/mist/vapor. Do not store with incompatible materials like strong oxidizing agents. Avoid dust formation and control ignition sources. Storage: Refrigerate. Store at 4C.
8. Exposure Controls/Personal Protection
Airborne Exposure Limits: None established.
Ventilation System: In general, dilution ventilation is a satisfactory health hazard control for this substance.
Personal Respirators (NIOSH Approved): Not expected to require personal respirator usage. For conditions of use where exposure to dust or mist is apparent and engineering controls are not feasible, a particulate respirator (NIOSH type N95 or better filters) may be worn.
Skin Protection: Wear protective gloves and clean body-covering clothing.
Eye Protection: Use chemical safety goggles and/or full-face shield where dusting or splashing of solutions is possible. Maintain eye wash fountain and quick-drench facilities in work area.
9. Physical and Chemical Properties
Appearance: White to off-white powder. Air Sensitive, Heat Sensitive.
Odor: Odorless.
Odor threshold: Not applicable.
pH: No data found.
Relative density: No data found.
Boiling Point: 733C predicted.
Melting Point: 228C-229C literature.
Flash point: No data found.
Auto-ignition temperature: No data found.
Decomposition temperature: No data found.
Upper/lower flammability or explosive limits: No data found.
Vapor pressure: No data found.
Vapor density: No data found.
Evaporation rate: No data found.
Flammability (solid, gas): No data found.
Partition coefficient: n-octanol/water: No data found.
Solubility: slightly soluble in organic solvents and it is practically insoluble in water.
Viscosity: No data found.
10. Stability and Reactivity
Stability: Stable under recommended conditions of use and storage.
Hazardous Decomposition Products: May produce oxides of nitrogen, sulfur, carbon, chlorine compounds along with fumes when heated to decomposition.
Hazardous Polymerization: Will not occur.
Incompatibilities: Strong oxidizing agents.
Conditions to Avoid: Heat, flame, ignition sources, dusting, and incompatibles.
11. Toxicological Information
Toxicity Data: No data found.
Carcinogenic Effects: Not a reported carcinogen by IARC, NTP, ACGIH, OSHA.
Mutagenic Effects: No data found.
Reproductive Effects: No data found.
Developmental Effects: No data found.
12. Ecological Information
Environmental Fate: No data found.
Persistence and degradability: No data found.
Toxicity: No data found.
Bioaccumulative potential: No data found.
Mobility in soil: No data found.
PBT and vPvB assessment: No data found.
13. Disposal Considerations
Whatever cannot be saved for recovery or recycling should be managed in an appropriate and approved waste disposal facility. Follow all the pollution control norms.
14. Transport Information
Land Transport DOT USA, TDG Canada & ADR/RID Europe: Not regulated.
Sea Transport IMDG/IMO: Not regulated.
Air Transport IATA/ICAO: Not regulated.
15. Regulatory Information
USA:
SARA 311/312 Hazardous Categorization: See section 2.
California Proposition 65: Not listed.
16. Other Information
DISCLAIMER: The information and recommendations set forth herein are presented in good faith and believed correct as of the date hereof. It is compiled from various sources, and it is not necessarily all inclusive nor fully adequate in every circumstance. In addition, these suggestions should not be confused with nor followed in violation of applicable laws, regulations, rules, or insurance requirements applicable. This MSDS sheet is intended only as a guide to the appropriate precautionary handling of the material by a professionally trained person using this product. Individuals receiving the information must exercise their independent judgment in determining its appropriateness for a particular purpose.
Anmol Chemicals & Pharmaceuticals Pvt. Ltd. is an off-shoot of Anmol Chemicals Taloja. It is located in MIDC Taloja and it is manufacturing pharmaceutical grades of API, Excepients, Food grade and Reagent grade chemicals. Anmol Chemicals & Pharmaceuticals Pvt. Ltd. is a several decades old group of companies, engaged in manufacturing, supplying, distributing, wholesale supplies for actual users, retail or small pack supplies for research and development chemicals, fine and speciality chemicals, pharmaceutical excipients, mineral fortifiers in chemically pure, Analytical reagent grade, IP BP USP Ph Eur EP JP and other pharmaceutical grade monograph including FCC Food grade chemicals and Nutraceuticals, Mineral Fortifiers at best prices.
Rivaroxaban Structure
CAS Number 366789-02-8, Rivaroxaban Manufacturer Exporter
ANMOL CHEMICALS & PHARMACEUTICALS Pvt. Ltd.
India, USA, Europe, UAE
TELEPHONE: +912223770100
Navi Mumbai, INDIA
e-mail: info(At the rate i.e. @)anmol.org
Copyright. 24-nov-24
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