Description

Pitavastatin CAS NO 154170-27-1 is a synthetic, highly potent statin belonging to the pyrrolidine class of HMG-CoA reductase inhibitors. This active pharmaceutical ingredient (API) is critical for the formulation of cholesterol-lowering medications, offering a strong therapeutic profile with a favorable pharmacokinetic and safety record. It is essential for pharmaceutical manufacturers and research institutions developing treatments for hyperlipidemia and cardiovascular disease management.

Application

• Primary Pharmaceutical API: Formulation of oral tablets and other dosage forms for the treatment of hypercholesterolemia and mixed dyslipidemia.
• Cardiovascular Disease Prevention: Key component in medications aimed at reducing the risk of cardiovascular events in high-risk patients.
• Research & Development: Used in preclinical and clinical studies for investigating new lipid-lowering therapies and combination treatments.
• Generic Drug Manufacturing: Serves as the core active ingredient for the production of generic pitavastatin calcium tablets following patent expiries.
• Reference Standard: Utilized as a high-purity analytical standard in quality control laboratories for method development and validation.

Basic Information

Product Name	Pitavastatin
CAS No.	154170-27-1
Molecular Formula	C₂₅H₂₄FNO₄
Molecular Weight	421.46 g/mol
Synonyms	Pitavastatin Calcium (common salt form); NK-104; Livalo® (brand name); Itavastatin; (3R,5S,6E)-7-[2-Cyclopropyl-4-(4-fluorophenyl)quinolin-3-yl]-3,5-dihydroxyhept-6-enoic Acid; (+)-Monocalcium bis((3R,5S,6E)-7-[2-cyclopropyl-4-(4-fluorophenyl)-3-quinolyl]-3,5-dihydroxyhept-6-enoate)
EINECS	Contact for details

Quality Control

Our Pitavastatin is manufactured under strict quality management systems, targeting purity levels suitable for pharmaceutical applications. Quality is assured through comprehensive analytical testing, including HPLC for assay and related substances, residual solvent analysis, and stringent control of elemental impurities. A Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment, ensuring compliance with ICH Q7 and relevant pharmacopeial guidelines.

Storage

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

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Assay (HPLC)	98.0% - 102.0% (on anhydrous basis)
Related Substances (HPLC)	Total impurities ≤ 1.0% Any individual impurity ≤ 0.5%
Water (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%
Heavy Metals	≤ 20 ppm
Residual Solvents (GC)	Complies with ICH Q3C

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