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Clopidogrel Bisulphate (Form I) is a high-purity antiplatelet Active Pharmaceutical Ingredient (API) widely used to prevent blood clots, myocardial infarction, stroke, and other thrombotic cardiovascular events. Form I is the thermodynamically stable crystalline modification, preferred in pharmaceutical formulations for its consistent stability, solubility, and reproducibility.
Bluepill Express manufactures this API under WHO-GMP, ISO, and cGMP-certified facilities, ensuring compliance with IP, BP, USP, and EP pharmacopoeial standards. Our Clopidogrel Bisulphate (Form I) is ideal for tablet and capsule formulations, including dual antiplatelet therapy (DAPT) with Aspirin.
Mechanism of Action
Clopidogrel Bisulphate inhibits ADP-induced platelet aggregation by irreversibly blocking the P2Y12 receptor on platelets. This prevents activation of the GPIIb/IIIa complex, reducing platelet aggregation and minimizing the risk of thrombotic events.
Chemical & Composition Information
| Parameter | Detail |
|---|---|
| Chemical Name | Methyl (+)-(S)-α-(2-chlorophenyl)-6,7-dihydrothieno[3,2-c]pyridin-5(4H)-acetate sulphate |
| Molecular Formula | C16H16ClNO2S·H2SO4 |
| Molecular Weight | 419.90 g/mol |
| CAS Number | 120202-66-6 |
| Form | Form I (Crystalline Stable Form) |
| Purity | ≥99% |
| Pharmacopoeial Standards | IP / BP / USP / EP |
Physical & Technical Properties
- Appearance: White to off-white crystalline powder
- Solubility: Freely soluble in methanol and ethanol; slightly soluble in water
- Melting Point: 182–184°C
- Optical Rotation: +55° to +60°
- Stability: Thermodynamically stable crystalline form
- Bulk Density: 0.35–0.55 g/ml
- Related Substances: ≤0.1% individual impurity, ≤0.3% total impurities
- Heavy Metals: ≤10 ppm
- Microbial Limits: Complies with pharmacopeial standards
Pharmacological Applications
- Prevention of myocardial infarction and ischemic stroke
- Management of acute coronary syndrome (ACS)
- Peripheral arterial disease (PAD) treatment
- Post-stent thrombosis prevention
- Combination therapy with Aspirin for dual antiplatelet therapy
Packaging & Storage
- Packaged in HDPE drums/fiber containers with double PE liners
- Available in 5 kg, 10 kg, 25 kg packs
- Shelf life: 36 months
- Store below 25°C in a dry, cool place, protected from light and moisture
Advantages of Bluepill Express API
- WHO-GMP, ISO, and cGMP-certified manufacturing
- Thermodynamically stable Form I
- High-purity and consistent batch-to-batch quality
- Complete COA, MSDS, TDS, and DMF-ready documentation
- Global export support with competitive pricing
Safety & Handling
- Use gloves, masks, and goggles while handling
- Avoid inhalation, ingestion, or skin contact
- Follow local EHS and GMP disposal guidelines
