Description

Pitavastatin 3-Oxo Sodium is a key pharmaceutical intermediate and reference standard in the synthesis of Pitavastatin, a potent HMG-CoA reductase inhibitor. This compound is critical for ensuring the quality, consistency, and regulatory compliance of the final active pharmaceutical ingredient (API). It is primarily required by pharmaceutical manufacturers, research institutions, and analytical laboratories involved in cardiovascular drug development and quality control.

Application

• Pharmaceutical Intermediate: A crucial building block in the chemical synthesis of Pitavastatin Calcium, the active ingredient in cholesterol-lowering medications.
• Reference Standard: Used as a high-purity standard in analytical methods (e.g., HPLC, LC-MS) for the identification and quantification of Pitavastatin and related substances.
• Process Development & Validation: Essential for research and development (R&D) and process scale-up activities in API manufacturing.
• Impurity Profiling: Serves as a specific impurity marker or a starting material for impurity synthesis in stability studies and method validation.
• Metabolite Research: Used in preclinical and clinical studies to investigate the metabolic pathways of Pitavastatin.
• Regulatory Filings: Supplied as a characterized material to support regulatory submissions (e.g., DMF, CMC sections) to agencies like the FDA and EMA.

Basic Information

Product Name	Pitavastatin 3-Oxo Sodium
CAS No.	2245811-12-3
Molecular Formula	C25H22FNO5Na
Molecular Weight	458.44 g/mol
Synonyms	Pitavastatin 3-Keto Sodium Salt; Pitavastatin 3-Oxo Sodium Salt; Pitavastatin Sodium 3-Oxo Derivative; (3R,5S)-7-[2-Cyclopropyl-4-(4-fluorophenyl)quinolin-3-yl]-3,5-dihydroxyhept-6-enoic acid 3-oxo sodium salt; Livalo Intermediate; NK-104 3-Oxo Sodium Salt
EINECS	Contact for details

Quality Control

Our Pitavastatin 3-Oxo Sodium is manufactured under strict quality management systems. Each batch is subjected to comprehensive analytical testing, including HPLC for purity, identification by IR and NMR, and residual solvent analysis, to ensure it meets stringent specifications for pharmaceutical use. A Certificate of Analysis (COA) detailing all test results is provided with every shipment to support your quality and regulatory requirements.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). Due to its hygroscopic nature, the container should be kept in a desiccated environment to prevent moisture absorption.

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%
Related Substances (HPLC)	Total impurities ≤2.0% Any single impurity ≤0.5%
Water Content (KF)	≤5.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines

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