Description

Fluvastatin Ep Impurity C is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and regulatory compliance of Fluvastatin, a widely prescribed cholesterol-lowering medication. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and impurity profiling. The availability of this well-characterized impurity standard is essential for maintaining stringent pharmacopeial standards in drug production.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the quality control and release testing of Fluvastatin API and finished dosage forms.
• Analytical Method Development: Used in HPLC, UPLC, and LC-MS methods to establish system suitability, specificity, and detection limits for impurity analysis.
• Regulatory Compliance & Documentation: Essential for preparing regulatory submissions (e.g., for FDA, EMA) to demonstrate comprehensive impurity identification and control strategies.
• Stability Studies: Employed to monitor the formation and levels of this specific impurity in Fluvastatin products under various storage conditions over time.
• Research & Development: Utilized in pharmaceutical R&D to study degradation pathways and the chemical behavior of Fluvastatin.
• Pharmacopeial Testing: Applied as a system suitability component in tests specified by the European Pharmacopoeia (EP) and other international pharmacopeias.

Basic Information

Item	Details
Product Name	Fluvastatin Ep Impurity C
CAS No.	779995-42-5
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 EP Impurity C; Fluvastatin Related Compound C; (E)-Fluvastatin; (3R,5S)-Fluvastatin; (E)-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 C is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity profile testing using advanced chromatographic (HPLC, LC-MS) and spectroscopic (NMR, IR) techniques to ensure compliance with pharmacopeial standards. 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) in a dry environment. This product is hygroscopic (moisture-sensitive); ensure the container is sealed tightly after each use to prevent absorption of atmospheric moisture.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual unknown impurity ≤ 0.5%
Water Content (KF)	≤ 1.0% w/w
Residue on Ignition	≤ 0.1%

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