Description

Atorvastatin Ep Impurity F CAS NO 887196-24-9 is a high-purity chemical reference standard, specifically identified as a known impurity of the blockbuster cholesterol-lowering drug, Atorvastatin. This compound is critical for pharmaceutical research, development, and quality control processes, ensuring the safety and efficacy of the final drug product. It is primarily used by analytical laboratories, regulatory bodies, and pharmaceutical manufacturers involved in method validation, stability studies, and compliance testing for Atorvastatin calcium API and its formulations.

Application

• Pharmaceutical Impurity Profiling and Identification in Atorvastatin calcium Active Pharmaceutical Ingredient (API).
• Analytical Method Development and Validation for HPLC, UPLC, and related chromatographic techniques.
• Quality Control and Batch Release Testing to monitor and control impurity levels as per ICH guidelines.
• Stability Studies to track the formation of degradation products under various stress conditions.
• Regulatory Submissions and Compliance, providing essential data for FDA, EMA, and other agency filings.
• Calibration of Analytical Instruments and as a system suitability standard.
• Research and Development of generic Atorvastatin formulations.
• Educational and Training Purposes in academic and industrial settings focusing on pharmaceutical analysis.

Basic Information

Product Name	Atorvastatin Ep Impurity F
CAS No.	887196-24-9
Molecular Formula	C33H35FN2O5
Molecular Weight	558.65 g/mol
Synonyms	Atorvastatin Impurity F; Atorvastatin Related Compound F; (3R,5R)-7-[2-(4-Fluorophenyl)-5-(1-methylethyl)-3-phenyl-4-(phenylcarbamoyl)-1H-pyrrol-1-yl]-3,5-dihydroxyheptanoic acid; Atorvastatin EP Impurity F; Atorvastatin USP Impurity F; Atorvastatin Degradant F; Atorvastatin Process Impurity F
EINECS	Contact for details

Quality Control

Every batch of Atorvastatin Ep Impurity F is manufactured and tested under strict quality management systems. Our products undergo rigorous analytical testing, including HPLC purity determination and structural confirmation (NMR, MS), to ensure compliance with pharmacopoeial standards such as EP and USP. A comprehensive Certificate of Analysis (COA) detailing identity, purity, and impurity profile is provided with each shipment and is available upon request.

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 material is hygroscopic (moisture-sensitive) and must be kept in a desiccated environment to maintain stability and purity.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (HPLC)	Retention time corresponds to reference standard
Identification (IR)	Spectrum matches reference spectrum
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%

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