Description

Fluvastatin is a synthetic, competitive inhibitor of HMG-CoA reductase, the rate-limiting enzyme in cholesterol biosynthesis. This high-purity active pharmaceutical ingredient (API) is essential for the formulation of effective lipid-lowering medications. It is primarily required by pharmaceutical manufacturers and research institutions developing treatments for hypercholesterolemia and cardiovascular disease management.

Application

• Pharmaceutical API: Primary use as the active ingredient in finished dosage forms, such as tablets and capsules, for cholesterol control.
• Generic Drug Manufacturing: Critical for the production of generic versions of cholesterol-lowering medications following patent expiry.
• Clinical Research & Development: Serves as a reference standard and raw material in preclinical and clinical studies for new cardiovascular therapies.
• Formulation Development: Used in R&D labs for developing new drug delivery systems, including sustained-release formulations.
• Biochemical Research: Employed as a tool compound in studies investigating the mevalonate pathway and cellular cholesterol metabolism.

Basic Information

Product Name	Fluvastatin
CAS No.	93957-54-1
Molecular Formula	C24H26FNO4
Molecular Weight	411.47 g/mol
Synonyms	(±)-Fluvastatin; Fluvastatin Sodium; Lescol; XU 62-320; (3R*,5S*,6E)-7-[3-(4-Fluorophenyl)-1-(1-methylethyl)-1H-indol-2-yl]-3,5-dihydroxy-6-heptenoic acid; (E)-Fluvastatin; Fluvastatin (free acid)
EINECS	Contact for details

Quality Control

Our Fluvastatin is manufactured under strict quality management systems. It undergoes rigorous analytical testing to ensure it meets high-purity standards suitable for pharmaceutical applications. A comprehensive Certificate of Analysis (COA) is provided with each batch, detailing parameters such as assay, related substances, residual solvents, and identification. We support compliance with major pharmacopoeial standards (e.g., USP, EP) upon request.

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 in a dry environment to maintain stability and potency.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms
Identification (HPLC)	Conforms
Assay (HPLC)	98.0% - 102.0%
Related Substances (HPLC)	Total impurities ≤ 2.0%
Single Unknown Impurity	≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 1.0%
Heavy Metals	≤ 20 ppm
Sulfated Ash	≤ 0.1%

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