World's Best-Selling Statin API for Cholesterol Reduction and Cardiovascular Risk Prevention
| Parameter | Specification |
|---|---|
| Appearance | White to off-white crystalline powder |
| Identification | IR & HPLC compliant |
| Assay (HPLC) | 98.0% – 102.0% |
| Loss on Drying | NMT 1.0% |
| Residue on Ignition | NMT 0.2% |
| Heavy Metals | NMT 10 ppm |
| pH (1% Solution) | 2.0 – 4.0 |
| Individual Impurity | ≤ 0.5% |
| Total Impurities | ≤ 1.5% |
Atorvastatin Calcium (CAS 134523-03-8) is a synthetic HMG-CoA reductase inhibitor (statin) that competitively reduces hepatic cholesterol biosynthesis, resulting in up-regulation of LDL receptors and significant reduction in LDL-C, triglycerides, and VLDL with mild elevation of HDL-C. As one of the top-selling pharmaceuticals globally and a WHO Essential Medicine, atorvastatin calcium is the benchmark API for cardiovascular risk reduction drug manufacturing.
Atorvastatin Calcium API sourcing requires critical control of the amorphous versus crystalline form ratio — the amorphous form predominates in commercial Lipitor® reference product offering superior dissolution, while some generic programs use crystalline hydrate Form I or Form VI. Lactone impurity (atorvastatin lactone) must be below 0.2% as it is a known active metabolite affecting bioequivalence. Triethylamine content, residual solvents (acetonitrile, toluene), and calcium content (by EDTA titration or ICP-OES) must meet USP/EP specifications.
Swapnroop supplies Atorvastatin Calcium API in both amorphous (high dissolution, preferred for most BE studies) and crystalline hydrate forms from our WHO-GMP Aurangabad facility. We provide polymorphic form characterisation by XRPD and DSC, validated lactone impurity control, and ICH-compliant stability data supporting generic ANDA and CTD filings in the world's largest statin market.
Atorvastatin Calcium API is supplied in double-polyethylene-lined fiber drums (10 kg, 25 kg) with desiccant and nitrogen blanket to protect the amorphous form from moisture-induced crystallisation. Temperature-controlled storage (2–8°C) available for amorphous grade to maintain dissolution-critical solid-state properties.
Get Bulk QuoteThe CAS number for Atorvastatin Calcium is 134523-03-8. It is the calcium salt form of Atorvastatin, the world's most widely prescribed statin.
Swapnroop supplies both amorphous Atorvastatin Calcium (preferred for tablet dissolution) and crystalline Form I. XRPD characterisation confirming the specific form is provided with every batch.
The amorphous form has significantly higher apparent aqueous solubility and dissolution rate compared to crystalline Form I, which translates to improved oral bioavailability in tablet formulations used by most commercial Atorvastatin generics.
Atorvastatin Lactone (the cyclic lactone degradation product) is controlled to ≤0.1% per batch. Swapnroop provides lactone impurity certificates with every batch as this is a critical quality attribute for statin stability.
MOQ is 25 kg with preferential pricing for 100 kg, 500 kg, and monthly program orders. We supply to major Indian statin tablet manufacturers with consistent monthly batch availability.
Swapnroop Drugs and Pharmaceuticals is a trusted Atorvastatin Calcium API manufacturer and bulk supplier in Aurangabad, Maharashtra, serving pharmaceutical formulation companies across India and 25+ international markets. Our WHO-GMP certified facility provides consistent Atorvastatin Calcium API supply with full pharmacopeial compliance, competitive pricing, and complete regulatory documentation for domestic and export programs.
As a Atorvastatin Calcium API exporter from Maharashtra, India, Swapnroop supports pharmaceutical companies worldwide with DMF-grade documentation, Certificate of Analysis, MSDS, impurity profiles, and regulatory filing assistance for USFDA, EMA, and CDSCO submissions. Contact us for Atorvastatin Calcium API pricing, samples, and sourcing support.