Also known as: Livalo; Itavastatin; NK-104
Pitavastatin is a synthetic HMG-CoA reductase inhibitor (statin) used for the treatment of hypercholesterolemia and mixed dyslipidemia. It competitively inhibits HMG-CoA reductase, the rate-limiting enzyme in hepatic cholesterol biosynthesis, reducing LDL-C and triglycerides while increasing HDL-C. Mediocon Inc manufactures Pitavastatin API at its GMP-certified facility in Aurangabad, Maharashtra, India.
| Parameter | Specification |
|---|---|
| CAS Number | 147526-32-7 |
| Molecular Formula | C25H24FNO4 |
| Molecular Weight | 421.46 g/mol |
| Grade | IP / BP |
| Category | HMG-CoA Reductase Inhibitor (Statin) |
| Appearance | White to off-white, crystalline powder |
| Solubility | Practically insoluble in water, slightly soluble in methanol, freely soluble in ethanol and in methylene chloride |
| Assay | NLT 98.0% |
| Loss on Drying | NMT 0.5% |
| Heavy Metals | NMT 20 ppm |
| Residue on Ignition | NMT 0.1% |
| Microbial Limits | Complies with pharmacopoeia |
| Identification | IR, HPLC Compliant |
| Batch No | PTV/24032026 |
| Mfg Date | MAR 2026 |
| Exp Date | FEB 2031 |
| Packing | 25 kg HDPE drums / as per requirement |