Description

(+)-3R,5S-Fluvastatin Sodium Salt is a high-purity, single-enantiomer active pharmaceutical ingredient (API) and a critical reference standard for analytical and research purposes. This compound is the pharmacologically active form of the widely prescribed HMG-CoA reductase inhibitor, fluvastatin, used to manage hypercholesterolemia. It is essential for pharmaceutical R&D, quality control laboratories, and manufacturers requiring a definitive standard for chiral purity and potency verification.

Application

• Pharmaceutical Active Ingredient (API): Primary use as the active enantiomer in the formulation of cholesterol-lowering medications.
• Analytical Reference Standard: Critical for HPLC, LC-MS, and other chromatographic methods to quantify and qualify fluvastatin in drug substances and finished products.
• Chiral Research & Development: Serves as a pure enantiomeric standard for studying stereoselective metabolism, pharmacokinetics, and pharmacodynamics.
• Impurity Profiling: Used to identify and control stereoisomeric impurities during API manufacturing and stability studies.
• Method Development & Validation: Essential for developing and validating analytical methods in compliance with ICH and pharmacopeial guidelines.
• Regulatory Submissions: Provides certified material for use in stability testing and documentation for regulatory filings (e.g., FDA, EMA).

Basic Information

Product Name	(+)-3R,5S-Fluvastatin Sodium Salt
CAS No.	155229-75-7
Molecular Formula	C24H25FNO4Na
Molecular Weight	433.45 g/mol
Synonyms	Fluvastatin Sodium Salt; (3R,5S)-Fluvastatin Sodium; Lescol Sodium Salt; XU 62-320; (E,3R,5S)-7-[3-(4-Fluorophenyl)-1-(1-methylethyl)-1H-indol-2-yl]-3,5-dihydroxy-6-heptenoic Acid Sodium Salt; (+)-(3R,5S)-Fluvastatin; (3R,5S)-Fluvastatin Monosodium Salt
EINECS	Contact for details

Quality Control

Our (+)-3R,5S-Fluvastatin Sodium Salt is manufactured under strict quality management systems. Each batch is subjected to comprehensive analytical testing, including chiral HPLC for enantiomeric purity, to ensure it meets stringent specifications suitable for pharmaceutical R&D and reference standard applications. A detailed Certificate of Analysis (COA) is provided with each shipment, confirming identity, purity, and compliance with relevant standards.

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 material is hygroscopic (moisture-sensitive) and must be kept in a desiccated environment to maintain stability and purity.

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)
Enantiomeric Purity (Chiral HPLC)	≥99.0%
Water Content (KF)	≤5.0%
Residue on Ignition	≤0.5%
Heavy Metals	≤20 ppm
Related Substances (HPLC)	Total impurities ≤2.0%

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