Description

Fluvastatin n-Ethyl Sodium Salt is a key impurity and reference standard used in the pharmaceutical development and quality control of Fluvastatin, a widely prescribed statin medication. This compound is critical for ensuring the purity, safety, and efficacy of the final drug product by enabling accurate identification and quantification of related substances. It is an essential material for analytical laboratories, regulatory affairs, and quality assurance departments within the global pharmaceutical and fine chemical industries.

Application

• Pharmaceutical Impurity Standard: Primary use as a certified reference material (CRM) for the identification and quantification of Fluvastatin n-Ethyl Sodium Salt impurity in Fluvastatin API and finished dosage forms.
• Analytical Method Development & Validation: Critical for developing, calibrating, and validating HPLC, UPLC, and LC-MS methods in quality control laboratories.
• Regulatory Compliance & Documentation: Supports regulatory filings (e.g., ANDA, NDA) with the FDA, EMA, and other global health authorities by providing necessary impurity profiles.
• Stability Studies: Used as a marker in forced degradation and long-term stability studies to monitor impurity formation in Fluvastatin formulations.
• Process Chemistry Research: Aids in the optimization of Fluvastatin synthesis by helping to identify and control process-related impurities.
• Pharmacopoeial Testing: Employed to meet testing requirements specified in pharmacopoeial monographs (USP, EP, BP) for Fluvastatin.

Basic Information

Product Name	Fluvastatin n-Ethyl Sodium Salt (Fluvastatin Impurity)
CAS No.	93936-64-2
Molecular Formula	C26H27FNO5Na
Molecular Weight	475.49 g/mol
Synonyms	Fluvastatin EP Impurity E; Fluvastatin Sodium Impurity E; (3R,5S,6E)-7-[3-(4-Fluorophenyl)-1-(1-methylethyl)-1H-indol-2-yl]-3,5-dihydroxy-6-heptenoic Acid n-Ethyl Sodium Salt; Sodium (3R,5S,6E)-7-[3-(4-fluorophenyl)-1-isopropyl-1H-indol-2-yl]-3,5-dihydroxyhept-6-enoate N-ethyl derivative; Lescol Impurity E; XU-62-320 Impurity; Fluvastatin Related Compound E
EINECS	Contact for details

Quality Control

Our Fluvastatin n-Ethyl Sodium Salt is manufactured under strict quality systems to ensure it meets the exacting standards required for pharmaceutical impurity analysis. Each batch is supported by a comprehensive Certificate of Analysis (COA) that includes data from orthogonal analytical techniques such as HPLC, LC-MS, NMR, and IR for full structural confirmation and purity verification. We adhere to relevant ICH guidelines for impurities and can supply material qualified against pharmacopoeial standards (USP, EP) upon request.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label. This product is hygroscopic (moisture-sensitive) and should be handled in a dry environment to prevent degradation. For long-term storage, consider desiccated conditions.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time corresponds to reference standard
Identification (IR)	Spectrum matches reference spectrum
Purity (HPLC)	≥ 95.0%
Water Content (KF)	≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C

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