Description

Fluvastatin Ep Impurity A -G is a high-purity reference standard specifically used in the analytical profiling of Fluvastatin, a widely prescribed cholesterol-lowering medication. This impurity is critical for pharmaceutical manufacturers and quality control laboratories to ensure drug safety, efficacy, and compliance with stringent pharmacopeial regulations. It is primarily utilized in research and development, method validation, and routine batch analysis within the pharmaceutical industry.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the identification and quantification of related substances in Fluvastatin Active Pharmaceutical Ingredient (API) and finished dosage forms.
• Analytical Method Development & Validation: Essential for developing, optimizing, and validating chromatographic methods (e.g., HPLC, UPLC) to accurately detect and measure impurities.
• Quality Control & Assurance (QC/QA): Used in routine batch release testing to monitor impurity levels against International Conference on Harmonisation (ICH) guidelines and pharmacopeial monographs (USP, EP).
• Stability Studies: Employed to track the formation of degradation products in Fluvastatin under various stress conditions (e.g., heat, light, humidity) to establish shelf life.
• Regulatory Compliance & Documentation: Supports regulatory filings (e.g., ANDA, NDA) by providing necessary impurity characterization data for health authorities like the FDA and EMA.
• Research on Drug Degradation Pathways: Aids in understanding the chemical stability and degradation mechanisms of Fluvastatin during synthesis and storage.

Basic Information

Product Name	Fluvastatin Ep Impurity A -G
CAS No.	93957-58-5
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 G; Fluvastatin Impurity G; Fluvastatin Related Compound G; (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

Our Fluvastatin Ep Impurity A -G is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC for purity, NMR and MS for structural confirmation, and residual solvent analysis, to ensure compliance with pharmacopeial standards. A comprehensive Certificate of Analysis (COA) detailing all test results, including chromatograms and spectra, is provided with every shipment to support your regulatory and quality needs.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). This compound 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)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual unknown impurity ≤ 0.5%
Water Content (KF)	≤ 1.0% w/w
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.