Description

Allyl Ester Of Atorvastatin Cyclic (Fluorophenyl) Impurity is a high-purity chemical reference standard critical for pharmaceutical research and development. This compound serves as a key impurity in the synthesis and quality control of Atorvastatin, a widely prescribed statin medication. It is essential for analytical laboratories and pharmaceutical manufacturers focused on method development, stability studies, and ensuring regulatory compliance for drug substance purity. Precise identification and quantification of this impurity are fundamental to maintaining the highest standards of drug safety and efficacy.

Application

• Pharmaceutical Reference Standard: Primary use as a certified impurity standard for calibrating analytical instruments like HPLC and LC-MS in quality control laboratories.
• Method Development and Validation: Critical for developing, optimizing, and validating chromatographic methods to separate and quantify process-related impurities in Atorvastatin API.
• Stability Indicating Studies: Used to monitor the degradation profile of Atorvastatin under various stress conditions (heat, light, humidity) as per ICH guidelines.
• Regulatory Compliance and Filing: Supports regulatory submissions (e.g., to FDA, EMA) by providing necessary impurity data for Drug Master Files (DMFs) and New Drug Applications (NDAs).
• Process Chemistry Research: Aids in understanding synthetic pathways and optimizing manufacturing processes to minimize the formation of this specific impurity.
• Academic and Contract Research: Serves as a research tool in universities and CROs for studies related to organic synthesis, impurity profiling, and analytical chemistry.

Basic Information

Product Name	Allyl Ester Of Atorvastatin Cyclic (Fluorophenyl) Impurity
CAS No.	1316643-57-8
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Atorvastatin Allyl Ester Cyclic Fluorophenyl Impurity; Atorvastatin Related Compound; (3R,5R)-7-[2-(4-Fluorophenyl)-5-(1-methylethyl)-3-phenyl-4-[(phenylamino)carbonyl]-1H-pyrrol-1-yl]-3,5-dihydroxyhept-6-enoic Acid Allyl Ester; Atorvastatin EP Impurity; Atorvastatin USP Impurity; ATRV Impurity
EINECS	Contact for details

Quality Control

This high-grade reference material is produced under strict quality management systems. Each batch is subjected to comprehensive analytical characterization using advanced techniques including HPLC, GC, NMR, and mass spectrometry to confirm identity and purity. Certificates of Analysis (COA) are provided, detailing batch-specific results. Our quality protocols are designed to meet the rigorous standards expected in pharmaceutical impurity analysis and regulatory support.

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 Certificate of Analysis. Keep the container in a dry, cool, and well-ventilated area. Handle and store in accordance with good laboratory practices.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Conforms
Identification (MS)	Conforms
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Residual Solvents (GC)	Meets ICH Q3C guidelines

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