Rivaroxaban CAS 366789-02-8
Rivaroxaban is a synthetic oxazolidinone-thiophene carboxamide active pharmaceutical ingredient (API) and direct Factor Xa inhibitor, widely used in anticoagulant formulation development, analytical reference work and impurity profiling projects. UETChem supplies high-purity rivaroxaban with strict in-house QC controls and full batch documentation, supporting reliable R&D and QA evaluation. Each shipment includes COA, TDS, SDS.
- CAS No: 366789-02-8
- Synonyms: BAY 59-7939; Rivaroxabanum
- EINECS: 810-863-1
- Molecular Formula: C₁₉H₁₈ClN₃O₅S
- Molecular Weight: 435.88 g/mol
- Appearance: White to almost white crystalline powder
- Purity (HPLC): ≥ 99.0%
- Assay (anhydrous basis): 98.0% – 102.0%
- Packaging: 1 g–100 g foil pouch/HDPE bottle; 1 kg foil-lined container; 5–25 kg fiber drum. Custom packaging available upon request.
- Main Applications: Pharmaceutical formulation R&D, analytical reference standards, impurity profiling, anticoagulant API development
Introduction to Rivaroxaban
Rivaroxaban is a synthetic, orally active direct Factor Xa inhibitor used as an active pharmaceutical ingredient in anticoagulant research and solid dosage development. It is typically supplied as a dry crystalline powder for formulation laboratories, analytical groups and export development projects.
The material is moisture- and light-sensitive. It is packed under dry conditions with desiccant, sealed in foil-lined containers, and verified against batch HPLC, Karl Fischer water and related-substance specifications before dispatch. This reduces moisture uptake risk during transit and provides QA teams with clean baseline data for incoming inspection.
Rivaroxaban Chemical & Physical Properties
| Property | Value |
|---|---|
| Chemical Name | 5-chloro-N-({(5S)-2-oxo-3-[4-(3-oxomorpholin-4-yl)phenyl]-1,3-oxazolidin-5-yl}methyl)thiophene-2-carboxamide |
| Melting Point | 228 – 231 °C |
| Solubility | Practically insoluble in water; soluble in DMSO; sparingly soluble in methanol |
| Hygroscopicity | Hygroscopic; keep container closed with desiccant |
| Optical Character | (S)-enantiomer; chiral purity controlled by chiral HPLC |
| Recommended Storage | 2 – 8 °C, dry, protected from light |
| Total Impurities | ≤ 0.50% |
| Water Content | ≤ 0.50% |
Available Grades
| Grade | Typical Assay | Typical Use |
|---|---|---|
| Research & Development Grade | ≥ 99.0% | HPLC method development, analytical screening |
| Pharmaceutical Intermediate Grade | ≥ 99.0% | Further processing, formulation development trials |
| Custom Purified Grade | ≥ 99.5% (when available) | Reference work, impurity qualification, tighter QA limits |
Applications of Rivaroxaban
Analytical reference work: Prepare stock solutions at 0.5–1.0 mg/mL in methanol or DMSO, then dilute to 0.01–0.10 mg/mL for HPLC or LC-MS/MS calibration. Verify solution stability before batch release.
Pharmaceutical formulation R&D: Use milligram to gram quantities in preformulation, blend uniformity and dissolution method feasibility studies. Target tablet strengths are defined by finished product dossiers.
Impurity and forced degradation studies: Spike related-compound work at 0.05%–0.2% of the main component, or use 5–50 mg per study set for stressed samples. Pair with related impurity reference standards and HPLC-grade acetonitrile when developing chromatographic separation methods.
Storage & Safety Precautions for Rivaroxaban
- Store at 2–8 °C in a dry, light-protected place. Keep the original container tightly closed with desiccant. After repeated opening, hygroscopic powder may cake; split large lots into sealed working portions.
- Wear appropriate PPE including safety glasses, nitrile gloves and lab coats during handling. Avoid inhalation of dust and direct skin/eye contact. Review the current SDS before handling for incompatibilities and emergency measures.
- Standard delivery is 7–15 days after order confirmation. Packaging ranges from gram-scale evaluation packages to 25 kg bulk fiber drums, with custom packing and palletizing available on request.
Rivaroxaban FAQ
Q: How do I choose the right grade for analytical method development?
A: Choose ≥99.0% assay material with total impurities at or below 0.50%. For HPLC or LC-MS work, also request chromatograms and residual solvent data.
Q: Which specification items should QA confirm before approving?
A: Confirm assay, related substances, chiral purity, water content, residual solvents and elemental impurity support. For solid dosage development, also ask for particle size and bulk density data.
Q: Is this material suitable for pharmaceutical formulation work?
A: It is suitable for formulation research, method development and qualification projects. The buyer is responsible for final regulatory approval, clinical suitability and finished product compliance.
Q: Are samples and documents available before purchase?
A: Yes. COA, TDS and SDS accompany each shipment, and free samples for testing are available to qualified laboratories.
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