Pitavastatin Calcium is a synthetic lipid-regulating active pharmaceutical ingredient (API) belonging to the statin class of medicines. It is a selective inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase, an enzyme involved in cholesterol biosynthesis. By inhibiting this enzyme, pitavastatin reduces cholesterol synthesis and promotes increased hepatic uptake of LDL cholesterol.
Pitavastatin Calcium is commonly supplied as Pitavastatin Calcium Hydrate, a crystalline hydrate form of the calcium salt. The Japanese Pharmacopoeia identifies the API as Pitavastatin Calcium Hydrate, with the chemical formula C₅₀H₄₆CaF₂N₂O₈·5H₂O and molecular weight 971.06 g/mol. The corresponding anhydrous calcium salt has molecular weight 880.98 g/mol and CAS 147526-32-7.
Pitavastatin Calcium Hydrate is described as a white to pale yellow powder. It is slightly soluble in methanol, very slightly soluble in water and ethanol (99.5), and dissolves in dilute hydrochloric acid. The Japanese Pharmacopoeia also recognizes crystal polymorphism for the substance.
The JP XVII monograph specifies 98.0–102.0% of Pitavastatin Calcium, calculated on the anhydrous basis. Identification includes UV-visible spectrophotometry, infrared absorption and a calcium salt identification test.
Quality control of Pitavastatin Calcium Hydrate includes identification, optical rotation, heavy metals, related substances, water content and assay. The JP monograph specifies optical rotation of +22.0° to +24.5°, heavy metals NMT 20 ppm, and water content 9.0–13.0%.
The related-substances procedure controls the peak at approximately 1.1 relative retention time to pitavastatin, other individual impurities and total impurities. The JP procedure uses liquid chromatography and includes specific system-suitability requirements.
Pitavastatin Calcium is used as an API in pharmaceutical formulations for the management of hyperlipidemia and elevated LDL cholesterol. Pitavastatin belongs to the HMG-CoA reductase inhibitor class of lipid-regulating medicines.
The API is used in the development and manufacture of oral pharmaceutical dosage forms, particularly immediate-release tablets containing pitavastatin calcium.
Pitavastatin Calcium API manufactured for pharmaceutical applications should be produced under appropriate pharmaceutical quality systems with controlled raw materials, validated manufacturing processes and analytical testing.
Quality control can include UV/IR identification, calcium identification, optical rotation, related substances, water determination, heavy-metal testing and quantitative assay, according to the applicable pharmacopoeial or approved product specification.
For commercial pharmaceutical requirements, customers can request the applicable Certificate of Analysis (CoA), specification sheet, technical documentation, regulatory documentation and quality information for Pitavastatin Calcium API.
| Parameter | Specification |
|---|---|
| Appearance | white to off-white crystalline powder |
| Identification | IR & HPLC compliant |
| Heavy Metals | NMT 20 ppm |
| Individual Impurity | NMT 0.5% |
| Total Impurities | NMT 1.0% |
| Water Content | 9.0–13.0% |
| Specific Rotation | +22.0° to +24.5° |