Description

Rac 5-Keto Fluvastatin CAS NO 1160169-39-0 is a key synthetic intermediate and impurity reference standard in the production of the cholesterol-lowering drug Fluvastatin. This compound is critical for pharmaceutical research and development, particularly in analytical method development, process chemistry, and quality control. It is primarily utilized by pharmaceutical manufacturers, contract research organizations (CROs), and academic institutions engaged in cardiovascular drug development and regulatory compliance testing.

Application

• Pharmaceutical Intermediate: A crucial building block in the synthesis of the active pharmaceutical ingredient (API) Fluvastatin sodium.
• Analytical Reference Standard: Used as a certified impurity standard for HPLC, LC-MS, and other chromatographic methods to quantify and qualify related substances in Fluvastatin API and finished dosage forms.
• Process Research & Development (R&D): Employed in route scouting, optimization studies, and scale-up processes for Fluvastatin manufacturing.
• Metabolite Studies: Serves as a reference compound in pharmacokinetic and metabolic pathway research for statin drugs.
• Quality Control & Assurance: Essential for establishing specification limits and validating analytical procedures in compliance with ICH and pharmacopeial guidelines (USP, EP).
• Regulatory Submissions: Provides necessary impurity characterization data for Drug Master Files (DMFs), Investigational New Drug (IND), and New Drug Application (NDA) filings.

Basic Information

Item	Detail
Product Name	Rac 5-Keto Fluvastatin
CAS No.	1160169-39-0
Molecular Formula	C24H26FNO5
Molecular Weight	427.47 g/mol
Synonyms	5-Keto Fluvastatin; 5-Oxo Fluvastatin; (3R*,5S*,6E)-7-[3-(4-Fluorophenyl)-1-(1-methylethyl)-1H-indol-2-yl]-3,5-dihydroxyhept-6-enoic acid 5-oxo derivative; Fluvastatin 5-Ketone; Fluvastatin Impurity; Rac-5-Keto Fluvastatin; (±)-5-Keto Fluvastatin
EINECS	Contact for details

Quality Control

Our Rac 5-Keto Fluvastatin is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including HPLC for purity, NMR and MS for structural confirmation, and residual solvent analysis. We provide a detailed Certificate of Analysis (COA) with each shipment, ensuring traceability and compliance with current industry standards for reference materials and pharmaceutical intermediates.

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 should be handled in a dry environment to prevent degradation. For long-term storage, consider desiccants or inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (HPLC)	Retention time corresponds to reference standard
Identification (IR)	Spectrum matches reference
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0%
Water Content (KF)	≤ 0.5%
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.