Rosuvastatin Calcium is a potent HMG-CoA reductase inhibitor (statin) used to lower cholesterol and triglycerides in the blood. It effectively reduces low-density lipoprotein (LDL-C) and increases high-density lipoprotein (HDL-C), making it a leading choice for the prevention and management of cardiovascular diseases.
At Bluepill Express, we manufacture high-purity Rosuvastatin Calcium API under strict WHO-GMP, ISO 9001:2015, and cGMP-certified facilities. Our API complies with IP/BP/USP/EP standards, ensuring superior quality, stability, and therapeutic effectiveness for global formulations.
Therapeutic Uses
- Treatment of hypercholesterolemia and hyperlipidemia
- Reduction of LDL-C, total cholesterol, and triglycerides
- Increase in HDL-C (good cholesterol)
- Prevention of atherosclerosis and cardiovascular events
- Effective for both familial and non-familial hypercholesterolemia
Mechanism of Action
Rosuvastatin inhibits 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase, the key enzyme in cholesterol biosynthesis.
This results in:
- Reduced hepatic cholesterol synthesis
- Upregulation of LDL receptors
- Enhanced clearance of LDL cholesterol from the bloodstream
Thus, Rosuvastatin promotes a favorable lipid profile, lowering cardiovascular risk.
Pharmacological Information
| Parameter | Details |
|---|---|
| Chemical Name | Bis[(E)-7-[4-(4-fluorophenyl)-6-isopropyl-2-[methyl(methylsulfonyl)amino]pyrimidin-5-yl] (3R,5S)-3,5-dihydroxyhept-6-enoic acid] calcium salt |
| Molecular Formula | (C44H54FN6O12S2)Ca |
| Molecular Weight | 1001.14 g/mol |
| CAS Number | 147098-20-2 |
| Therapeutic Category | Lipid-Lowering Agent / Statin |
| Pharmacopoeial Standards | IP / BP / USP / EP |
Physical & Chemical Properties
| Property | Description |
|---|---|
| Appearance | White to off-white crystalline powder |
| Odor | Odorless |
| Melting Point | 155°C – 160°C |
| Solubility | Slightly soluble in water, freely soluble in methanol |
| Assay (on dried basis) | 98.0% – 102.0% |
| pH (1% solution) | 4.0 – 6.5 |
Technical Specifications
| Test | Specification |
|---|---|
| Appearance | White crystalline 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 |
| Specific Optical Rotation | +20° to +25° |
| Storage | Store below 25°C, protected from moisture and light |
Applications
- Used in tablet and capsule formulations for cholesterol management
- Suitable for monotherapy or combination therapy with Ezetimibe, Fenofibrate, or Amlodipine
- Reduces risk of stroke and heart attack
- Used in preventive cardiology formulations
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: Product name, batch number, manufacturing & expiry date, net weight, storage instructions
Shelf Life: 5 years (below 25°C)
Export Regions: Africa, Middle East, Asia, CIS, and Latin America
