Description

(3S,5R)-Fluvastatin Sodium Salt is the active pharmaceutical ingredient (API) form of a potent HMG-CoA reductase inhibitor. This high-purity compound is critical for the research, development, and manufacturing of cholesterol-lowering medications. It is primarily required by pharmaceutical companies, research institutions, and contract manufacturing organizations (CMOs) engaged in cardiovascular drug production and advanced pharmacological studies.

Application

• Pharmaceutical API: Primary active ingredient in the formulation of Fluvastatin tablets and capsules for hyperlipidemia treatment.
• Reference Standard: Used as a certified reference material (CRM) in analytical laboratories for method development, validation, and quality control testing.
• Biochemical Research: Serves as a key tool for studying the mechanism of HMG-CoA reductase inhibition and cholesterol biosynthesis pathways.
• Drug Development: Employed in pre-clinical and clinical research for developing new statin-based therapies or combination drugs.
• Generic Drug Manufacturing: Essential for companies producing bioequivalent generic versions of Fluvastatin.
• Process Development: Used in optimizing and scaling up synthetic routes for statin production.

Basic Information

Product Name	(3S,5R)-Fluvastatin Sodium Salt
CAS No.	94061-81-1
Molecular Formula	C24H25FNO4Na
Molecular Weight	433.45 g/mol
Synonyms	Fluvastatin Sodium; (3R,5S)-Fluvastatin Sodium Salt; Lescol Sodium Salt; XU 62-320; (±)-Fluvastatin Sodium Salt; (E)-(3R,5S,6E)-7-[3-(4-Fluorophenyl)-1-(1-methylethyl)-1H-indol-2-yl]-3,5-dihydroxy-6-heptenoic Acid Sodium Salt; Sodium (3R,5S,6E)-7-[3-(4-fluorophenyl)-1-isopropyl-1H-indol-2-yl]-3,5-dihydroxyhept-6-enoate
EINECS	Contact for details

Quality Control

Our (3S,5R)-Fluvastatin Sodium Salt is manufactured under strict quality systems. Each batch is tested to ensure it meets high-purity standards suitable for pharmaceutical applications. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing purity, identity, and impurity profiles. We support compliance with cGMP, ICH Q7 guidelines, and relevant pharmacopeial standards (USP/EP).

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 (moisture-sensitive) nature, the container must be kept tightly sealed in a dry environment to prevent degradation. For long-term storage, consider desiccants or inert atmosphere.

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% (on anhydrous basis)
Water Content (KF)	≤5.0%
Related Substances (HPLC)	Total impurities ≤2.0% Any single impurity ≤0.5%
Residual Solvents (GC)	Complies with ICH Q3C
Heavy Metals	≤20 ppm

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