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Atorvastatin Calcium Trihydrate is a high-purity HMG-CoA reductase inhibitor (statin API) used to lower cholesterol and triglyceride levels in patients with hyperlipidemia and cardiovascular disease risk. It works by inhibiting the HMG-CoA reductase enzyme, reducing cholesterol synthesis in the liver, and increasing LDL receptor activity for improved clearance of LDL cholesterol from the bloodstream.
Bluepill Express manufactures Atorvastatin Calcium Trihydrate under WHO-GMP, ISO, and cGMP-certified facilities, ensuring exceptional purity, stability, and batch-to-batch consistency. The API is suitable for tablets, capsules, and fixed-dose combination formulations and meets international IP, USP, BP, and EP pharmacopoeial standards.
Therapeutic Classification
- Lipid-lowering agent
- HMG-CoA reductase inhibitor (Statin)
- Cardiovascular risk reduction
- Cholesterol and triglyceride management
Mechanism of Action
Atorvastatin inhibits HMG-CoA reductase, the rate-limiting enzyme in cholesterol biosynthesis, resulting in:
- Decreased hepatic cholesterol production
- Upregulation of LDL receptors
- Increased clearance of LDL cholesterol
- Reduced total cholesterol, LDL-C, triglycerides, and apolipoprotein B
It is effective in primary and secondary prevention of cardiovascular events in patients with elevated cholesterol levels or other risk factors.
Chemical & Composition Information
| Parameter | Details |
|---|---|
| Chemical Name | Calcium, (3R,5R)-7-[2-(4-fluorophenyl)-3-phenyl-4-(phenylcarbamoyl)-5-propan-2-ylpyrrol-1-yl]-3,5-dihydroxyheptanoate trihydrate |
| Molecular Formula | C66H68CaF2N4O10·3H2O |
| Molecular Weight | 1209.42 g/mol |
| CAS Number | 134523-03-8 |
| Form | Trihydrate crystalline powder |
| Pharmacopoeial Standards | IP / USP / BP / EP |
| Therapeutic Class | HMG-CoA reductase inhibitor (Statin) |
Physical & Chemical Properties
- Appearance: White to off-white crystalline powder
- Solubility: Practically insoluble in water; soluble in methanol, ethanol
- Melting Point: 159–162°C
- Optical Rotation: + [specific rotation per pharmacopoeia]
- Stability: Chemically stable under recommended storage conditions
Technical Specifications (Bluepill Express Standards)
| Parameter | Specification |
|---|---|
| Assay (on anhydrous basis) | 98.0% – 102.0% |
| Identification | IR, UV, and HPLC spectra match reference standard |
| Water Content (KF) | 7.0–10.0% (as trihydrate) |
| Residue on Ignition | ≤ 0.1% |
| Related Substances | ≤ 0.5% individual impurity, ≤ 1.0% total impurities |
| Bulk Density | 0.3 – 0.5 g/ml |
| Particle Size Distribution | Customizable, D90 < 250 μm |
| Heavy Metals | ≤ 10 ppm |
| Microbial Limits | Compliant with pharmacopeial standards |
Pharmacological Applications
- Hyperlipidemia management
- Dyslipidemia therapy
- Primary prevention of cardiovascular events
- Secondary prevention post-myocardial infarction
- Combination therapy with other lipid-lowering agents
Dosage Forms
- Tablets: 10 mg, 20 mg, 40 mg, 80 mg
- Fixed-dose combinations with Ezetimibe or other statins
- Film-coated and immediate-release formulations
Manufacturing Excellence – Bluepill Express
- WHO-GMP, ISO 9001:2015, and cGMP certified
- Controlled crystallization to maintain trihydrate form
- Batch-to-batch uniformity in purity, particle size, and moisture content
- Full regulatory documentation: COA, MSDS, TDS, DMF-ready dossier
- Global export-ready API with competitive pricing and reliable delivery
Packaging & Storage
- HDPE drums or fiber containers with PE liners
- Pack sizes: 5 kg / 10 kg / 25 kg
- Shelf Life: 36 months under recommended storage
- Storage: Store below 25°C, in a dry, cool environment, protected from light and moisture
Safety & Handling
- Use protective gloves, mask, and goggles
- Avoid inhalation, ingestion, and contact with eyes/skin
- Follow local GMP and EHS guidelines for handling and disposal
