Rivaroxaban is a sophisticated Active Pharmaceutical Ingredient (API) categorized as a Direct Oral Anticoagulant (DOAC) and a highly selective Factor Xa inhibitor, manufactured at Parand Darou Co. It acts as a critical raw material for the production of finished dosage forms indicated for the prevention and treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), as well as for stroke prophylaxis in patients with non-valvular atrial fibrillation.
Mechanism of Action & Clinical Advantages
Rivaroxaban exerts its therapeutic effect by directly and selectively inhibiting Factor Xa (both free and clot-bound). This blockade of the final common pathway of the coagulation cascade effectively prevents the conversion of prothrombin to thrombin. Compared to traditional anticoagulants like warfarin, Rivaroxaban offers clinical advantages including rapid onset of action, predictable pharmacokinetics, no requirement for routine INR monitoring, and a reduced potential for drug-drug or food-drug interactions.
Quality Standards, Specifications & Storage
At Parand Darou, Rivaroxaban is synthesized and purified in strict adherence to international monographs, including British Pharmacopoeia (BP) and United States Pharmacopeia (USP). The API is characterized by a high chemical purity of ≥ 99.5%, enantiomeric purity > 99.0%, and controlled moisture content (≤ 1.0%). To maintain its chemical stability for the guaranteed 24-month shelf life, the product is packaged in tight, light-resistant containers and must be stored at controlled room temperature, protected from heat and moisture.
General Information
| Product Name | Rivaroxaban | |
| Chemical Name | 5-Chloro-N-({(5S)-2-oxo-3-[4-(3-oxomorpholin-4-yl)phenyl]-1,3-oxazolidin-5-yl}methyl)thiophene-2-carboxamide | |
| Manufacturer | Parand Darou Co. | |
| CAS No. | 366789-02-8 | |
| Category | Anticoagulant | |
| Pharmacopoeia | BP, USP |
Specification
| Molecular formula | C19H18ClN3O5S | Residue on ignition | Max. 0.1% | |||
| Molecular weight | 435.88 | Purity | Min. 99.5% | |||
| Appearance | White or yellowish powder | Assay | 98.0% to 102.0% (anhydrous) | |||
| Solubility | Practically insoluble in water, freely soluble in DMSO, practically insoluble in ethanol & heptan | Storage | Tight, light-resistant containers | |||
| Water | Max. 1.0% | Stability | Stable 2 yrs at R.T. | |||
| Enantiomeric purity | NLT 99.0% |
