Description

(3S,5S)-Fluvastatin Sodium Salt is the active pharmaceutical ingredient (API) form of a synthetic, third-generation statin used to manage cholesterol levels. Its high purity and defined stereochemistry are critical for ensuring consistent pharmacological efficacy and safety in final drug formulations. This compound is essential for pharmaceutical manufacturers and research institutions developing and producing lipid-regulating medications.

Application

• Active Pharmaceutical Ingredient (API) in the manufacture of finished dosage forms for cholesterol-lowering drugs.
• Pharmaceutical Research & Development for studying HMG-CoA reductase inhibition and lipid metabolism.
• Reference Standard in analytical laboratories for quality control and method validation of fluvastatin-based products.
• Formulation Development for creating tablets, capsules, and other oral solid dosage forms.
• Clinical Trial Material for use in studies evaluating new therapeutic applications or formulations.
• Generic Drug Manufacturing as a key component in bioequivalent generic versions of branded fluvastatin medications.

Basic Information

Product Name	(3S,5S)-Fluvastatin Sodium Salt
CAS No.	194935-01-8
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-dihydroxyhept-6-enoic 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,5S)-Fluvastatin Sodium Salt is manufactured under strict quality management systems. Each batch is tested to ensure it meets high-purity standards suitable for pharmaceutical applications, with specifications typically aligned with major pharmacopoeial guidelines. A comprehensive Certificate of Analysis (COA) detailing identity, purity, and impurity profiles is provided with every shipment.

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 dry environment to maintain stability and potency.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Assay (HPLC)	98.0% - 102.0% (on anhydrous basis)
Water Content (KF)	≤ 5.0%
Related Substances (HPLC)	Individual impurity ≤ 0.5%; Total impurities ≤ 2.0%
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.