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Warfarin Sodium (Amorphous) is a vitamin K antagonist widely used as an oral anticoagulant to prevent and treat thromboembolic disorders. It inhibits the synthesis of vitamin K-dependent clotting factors, thereby reducing the risk of blood clots, stroke, and heart attack.
At Bluepill Express, we provide high-purity Warfarin Sodium Amorphous API, manufactured under WHO-GMP, ISO 9001:2015, and cGMP-certified facilities. Our API meets IP/BP/USP/EP standards and is designed for consistent bioavailability and stability in oral dosage forms.
Therapeutic Uses
- Prevention and treatment of venous thromboembolism (VTE)
- Management of pulmonary embolism (PE) and deep vein thrombosis (DVT)
- Prevention of stroke in patients with atrial fibrillation
- Prophylaxis in patients with mechanical heart valves
- Adjunct therapy in post-surgical thromboembolic risk
Mechanism of Action
Warfarin Sodium inhibits vitamin K epoxide reductase, preventing the regeneration of reduced vitamin K required for the synthesis of clotting factors II, VII, IX, and X.
Key effects include:
- Reduced formation of active clotting factors
- Decreased blood coagulation and clot formation
- Effective long-term anticoagulation therapy
Pharmacological Information
| Parameter | Details |
|---|---|
| Chemical Name | 3-(α-Acetonylbenzyl)-4-hydroxycoumarin sodium salt |
| Molecular Formula | C19H15NaO4 |
| Molecular Weight | 308.32 g/mol |
| CAS Number | 129-06-6 |
| Therapeutic Category | Anticoagulant / Vitamin K Antagonist |
| Pharmacopoeial Standards | IP / BP / USP / EP |
Physical & Chemical Properties
| Property | Description |
|---|---|
| Appearance | White to off-white amorphous powder |
| Odor | Odorless |
| Melting Point | 153°C – 155°C |
| Solubility | Soluble in water; soluble in ethanol |
| Assay (on dried basis) | 98.0% – 102.0% |
| pH (1% solution) | 6.0 – 8.0 |
Technical Specifications
| Test | Specification |
|---|---|
| Appearance | White to off-white amorphous powder |
| Identification | IR / HPLC – Complies |
| Assay (Purity) | 98.0% – 102.0% |
| Loss on Drying | ≤ 1.0% |
| Residue on Ignition | ≤ 0.1% |
| Related Substances | ≤ 0.3% (individual), ≤ 0.5% (total) |
| Heavy Metals | ≤ 10 ppm |
| Storage | Store below 25°C, protected from moisture and light |
Applications
- Oral tablet and capsule formulations for anticoagulation therapy
- Prevention of thromboembolic events in at-risk patients
- Formulated for both branded and generic anticoagulants
- Suitable for hospital and retail pharmacy supply chains
Documentation Provided
- Certificate of Analysis (COA)
- Material Safety Data Sheet (MSDS)
- Technical Data Sheet (TDS)
- Stability Data (ICH guidelines)
- Drug Master File (DMF) – available on request
Packaging & Export Details
| Packaging Type | Net Weight |
|---|---|
| HDPE Drum | 25 kg |
| Fiber Drum | 25 kg |
| LDPE Inner Bag | 1 kg / 5 kg / 10 kg |
Labeling Includes: Product name, batch number, manufacturing & expiry date, net weight, storage instructions.
Shelf Life: 5 years (stored below 25°C)
Export Markets: Africa, Europe, Asia, Latin America, and Middle East
