Description

Atorvastatin Cyclic (Fluorophenyl) Impurity is a high-purity reference standard used in the analytical profiling of atorvastatin, a leading statin medication. This compound is critical for pharmaceutical research and development, enabling the identification, quantification, and control of specific process-related impurities to ensure drug safety and efficacy. It is an essential material for quality control laboratories, regulatory affairs, and analytical scientists working on method development and validation for atorvastatin API and finished dosage forms.

Application

• Pharmaceutical Reference Standard: Primary use as a certified impurity standard for HPLC, LC-MS, and other chromatographic methods in atorvastatin analysis.
• Method Development and Validation: Crucial for developing and validating stability-indicating analytical methods as per ICH Q2(R1) guidelines.
• Quality Control & Assurance: Used in routine QC testing of atorvastatin active pharmaceutical ingredient (API) and finished drug products to monitor impurity levels against ICH Q3A/B thresholds.
• Regulatory Compliance & Filings: Supports the preparation of regulatory documentation (e.g., ANDA, NDA) by providing characterized impurity data for health authorities like the US FDA and EMA.
• Stability Studies: Employed in forced degradation and long-term stability studies to track the formation of this specific impurity over time and under various stress conditions.
• Process Chemistry Research: Aids chemists in understanding and optimizing the atorvastatin synthesis pathway to minimize the formation of this cyclic impurity.

Basic Information

Product Name	Atorvastatin Cyclic (Fluorophenyl) Impurity
CAS No.	873950-18-6
Molecular Formula	C33H35FN2O5
Molecular Weight	558.65 g/mol
Synonyms	Atorvastatin Fluorophenyl Cyclic Impurity; Atorvastatin EP 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 Lactone Impurity (Fluorophenyl); Atorvastatin Process Impurity; CAS 873950-18-6
EINECS	Contact for details

Quality Control

Every batch of Atorvastatin Cyclic (Fluorophenyl) Impurity is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity profile testing using advanced techniques like HPLC, LC-MS, and NMR to ensure compliance with pharmacopeial standards. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results for assay, related substances, residual solvents, and other critical parameters.

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); ensure the container is sealed tightly after each use to prevent absorption of atmospheric moisture, which may affect stability and purity.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time matches reference standard
Identification (IR)	Spectrum conforms to reference
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0% Any individual unknown impurity ≤ 1.0%
Water Content (KF)	≤ 2.0%
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.