Description

(-)-3S,5R-Fluvastatin Sodium Salt is the specific enantiomeric form of the active pharmaceutical ingredient for the cholesterol-lowering medication fluvastatin. This high-purity compound is critical for pharmaceutical R&D and manufacturing, ensuring precise biological activity and regulatory compliance. It is primarily required by pharmaceutical companies and research institutions engaged in the development, formulation, and analytical testing of enantiomerically pure statin therapies.

Application

• Active Pharmaceutical Ingredient (API) for the synthesis of enantiomerically pure fluvastatin medications.
• Pharmaceutical Reference Standard for quality control and analytical method development (HPLC, LC-MS).
• Biochemical Research for studying HMG-CoA reductase inhibition mechanisms and metabolic pathways.
• Formulation Development for creating novel dosage forms such as sustained-release tablets or capsules.
• Process Chemistry & Scale-up studies in pharmaceutical manufacturing.
• Regulatory Submissions, providing certified material for stability studies and dossier preparation.

Basic Information

Product Name	(-)-3S,5R-Fluvastatin Sodium Salt
CAS No.	155229-76-8
Molecular Formula	C24H25FNO4Na
Molecular Weight	433.45 g/mol
Synonyms	Fluvastatin Sodium; (3R,5S)-Fluvastatin Sodium Salt; (E,3R,5S)-7-[3-(4-Fluorophenyl)-1-(1-methylethyl)-1H-indol-2-yl]-3,5-dihydroxyhept-6-enoic Acid Sodium Salt; Lescol® API; XU 62-320 Sodium Salt; (3R,5S,6E)-Fluvastatin Sodium; Sodium (3R,5S)-fluvastatin
EINECS	Contact for details

Quality Control

Our (-)-3S,5R-Fluvastatin Sodium Salt is manufactured under strict quality systems suitable for pharmaceutical applications. Each batch is tested to meet stringent specifications for identity, purity, and enantiomeric excess, aligning with ICH guidelines. A comprehensive Certificate of Analysis (COA) detailing chromatographic purity, chiral purity, residual solvents, and other critical parameters is provided with every shipment.

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 under anhydrous conditions. For long-term storage, consider desiccated or inert atmosphere packaging.

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)
Chiral Purity (Enantiomeric Excess)	≥99.0%
Water Content (KF)	≤5.0%
Residual Solvents (GC)	Meets ICH Q3C limits
Heavy Metals	≤20 ppm

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