Description

Pitavastatin CAS NO 147511-69-1 is a synthetic, highly potent statin belonging to the chemical class of pyrrole derivatives. It is a critical active pharmaceutical ingredient (API) valued for its superior efficacy in managing hypercholesterolemia and dyslipidemia with a favorable pharmacokinetic profile. This compound is essential for pharmaceutical manufacturers developing next-generation cardiovascular therapeutics, including tablets and other oral dosage forms, to reduce LDL cholesterol levels effectively.

Application

• Primary Active Pharmaceutical Ingredient (API) in the manufacture of Pitavastatin calcium tablets and other oral formulations.
• Core component in cardiovascular drugs targeting the treatment of primary hyperlipidemia and mixed dyslipidemia.
• Used in pharmaceutical research and development for studying HMG-CoA reductase inhibition mechanisms.
• Key material in the production of generic and branded pharmaceutical products for global markets.
• Reference standard in analytical laboratories for quality control and method validation (HPLC, LC-MS).
• Intermediate for further chemical synthesis in advanced pharmaceutical studies.

Basic Information

Product Name	Pitavastatin
CAS No.	147511-69-1
Molecular Formula	C25H24FNO4
Molecular Weight	421.46 g/mol
Synonyms	Pitavastatin (Base); NK-104; (3R,5S,6E)-7-[2-Cyclopropyl-4-(4-fluorophenyl)quinolin-3-yl]-3,5-dihydroxyhept-6-enoic Acid; Livalo® (Brand Name for Calcium Salt); Itavastatin; Nisvastatin; Kowa Brand Pitavastatin
EINECS	Contact for details

Quality Control

Our Pitavastatin is manufactured under strict quality management systems. It undergoes rigorous analytical testing to ensure it meets high-purity standards suitable for pharmaceutical applications, including identification, assay, and control of related substances and residual solvents. A comprehensive Certificate of Analysis (COA) is provided with each batch, detailing compliance with in-house specifications. We support compliance with ICH guidelines, and our quality systems are designed to meet the demands of global regulatory frameworks.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). This product is hygroscopic (moisture-sensitive) and must be kept in a dry environment to maintain stability and potency. For long-term storage, consider using desiccants.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Assay (HPLC)	98.0% - 102.0% (on anhydrous basis)
Related Substances (HPLC)	Individual impurity: NMT 0.5% Total impurities: NMT 2.0%
Water (KF Titration)	NMT 1.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Heavy Metals	NMT 20 ppm

Note: Specifications can be tailored. Please contact us for the detailed technical data sheet of a specific grade.