Description

(3R,5R)-Fluvastatin Sodium Salt is the active pharmaceutical ingredient (API) of the widely prescribed cholesterol-lowering medication, fluvastatin. This specific stereoisomer is critical for ensuring maximum therapeutic efficacy and minimizing potential side effects. It is an essential raw material for pharmaceutical manufacturers developing and producing generic or branded statin formulations, as well as for research institutions conducting metabolic and cardiovascular disease studies.

Application

• Pharmaceutical API: Primary active ingredient in the manufacture of fluvastatin tablets and capsules for the treatment of hypercholesterolemia and dyslipidemia.
• Generic Drug Production: Key starting material for companies producing bioequivalent versions of branded fluvastatin medications.
• Clinical Research: Used as a reference standard or active component in preclinical and clinical trials investigating cholesterol management.
• Metabolic Disorder Studies: Valuable compound for in-vitro and in-vivo research on the HMG-CoA reductase pathway and lipid metabolism.
• Formulation Development: Employed in R&D for developing new drug delivery systems, such as controlled-release formulations of fluvastatin.

Basic Information

Product Name	(3R,5R)-Fluvastatin Sodium Salt
CAS No.	194934-99-1
Molecular Formula	C24H25FNO4Na
Molecular Weight	433.45 g/mol
Synonyms	Fluvastatin Sodium; (3R,5R)-Fluvastatin Sodium; Lescol Sodium Salt; (3R,5R)-7-[3-(4-Fluorophenyl)-1-(1-methylethyl)-1H-indol-2-yl]-3,5-dihydroxyhept-6-enoic Acid Sodium Salt; XU 62-320; CI-981 Sodium Salt; (E,3R,5R)-Fluvastatin Sodium
EINECS	Contact for details

Quality Control

Our (3R,5R)-Fluvastatin Sodium Salt is manufactured under strict quality systems. Every batch is tested to ensure it meets high-purity standards suitable for pharmaceutical applications, with comprehensive analysis covering identity, potency, and impurity profiles. A Certificate of Analysis (COA) is provided with each shipment, detailing results against specifications for assay, related substances, residual solvents, and other critical parameters.

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 must be kept tightly sealed in a dry environment to prevent moisture absorption.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference standard
Identification (HPLC)	Retention time matches reference
Assay (HPLC)	98.0% - 102.0% (on anhydrous basis)
Related Substances (HPLC)	Individual impurity: NMT 0.5% Total impurities: NMT 2.0%
Water Content (KF)	NMT 5.0%
Residual Solvents (GC)	Complies with ICH Q3C
Specific Rotation	Contact for details

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