Description

Fluvastatin Ep Impurity E is a specified impurity and degradation product of the cholesterol-lowering drug Fluvastatin. This compound is critical for pharmaceutical research and development, serving as a key reference standard for analytical method development, validation, and quality control. It is essential for manufacturers and analytical laboratories in the pharmaceutical industry who require high-purity chemical standards to ensure the safety, efficacy, and regulatory compliance of their active pharmaceutical ingredients (APIs).

Application

• Primary use as a certified reference standard (CRS) for the analysis of Fluvastatin sodium.
• Critical component in analytical method development and validation (HPLC, UPLC, LC-MS) for impurity profiling.
• Used in pharmaceutical quality control (QC) laboratories to monitor and quantify impurity levels in drug substances and products.
• Essential for stability studies to understand the degradation pathways of Fluvastatin.
• Serves as a system suitability standard in regulatory submissions (e.g., for FDA, EMA) to demonstrate analytical control.
• Used in research and development to study the chemical and metabolic behavior of Fluvastatin-related compounds.

Basic Information

Product Name	Fluvastatin Ep Impurity E
CAS No.	920275-10-1
Molecular Formula	C24H26FNO4
Molecular Weight	411.47 g/mol
Synonyms	(3R,5S)-7-[3-(4-Fluorophenyl)-1-(1-methylethyl)-1H-indol-2-yl]-3,5-dihydroxyhept-6-enoic Acid; Fluvastatin Impurity E; Fluvastatin EP Impurity E; Fluvastatin Related Compound E; Lescol Impurity E; (E)-Fluvastatin; (3R,5S,6E)-7-[3-(4-Fluorophenyl)-1-isopropyl-1H-indol-2-yl]-3,5-dihydroxyhept-6-enoic Acid
EINECS	Contact for details

Quality Control

Every batch of Fluvastatin Ep Impurity E is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity confirmation, purity analysis, and impurity profiling using advanced techniques such as HPLC, LC-MS, and NMR to ensure compliance with pharmacopeial standards (e.g., EP, USP). A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label or COA. This material is hygroscopic (moisture-sensitive) and should be handled in a dry environment to maintain stability.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Any individual impurity ≤ 1.0%
Total Impurities	≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 1.0%

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