Description

The Allyl Ester Of Atorvastatin Cyclic (Isopropyl) Impurity is a high-purity chemical reference standard critical for pharmaceutical research and development. This compound serves as a specified impurity in the quality control and analytical validation of Atorvastatin, a leading statin medication. It is essential for analytical chemists and quality assurance professionals in the pharmaceutical industry who require reliable standards for method development, stability studies, and regulatory compliance. Ensuring the integrity of your analytical data begins with sourcing well-characterized impurities like this one.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material for the identification and quantification of impurities in Atorvastatin Active Pharmaceutical Ingredient (API) and finished drug products.
• Analytical Method Development & Validation: Critical for developing, optimizing, and validating HPLC, UPLC, or LC-MS methods to monitor this specific degradant or process-related impurity.
• Stability Studies & Forced Degradation: Used to understand the degradation pathways of Atorvastatin and to establish shelf-life specifications for drug formulations.
• Quality Control & Batch Release Testing: Employed in QC laboratories to ensure that Atorvastatin batches meet stringent pharmacopeial (e.g., USP, EP) impurity limits.
• Regulatory Submissions: Provides essential data for regulatory filings (e.g., with FDA, EMA) to demonstrate thorough impurity profiling and control strategies.
• Research on Degradation Chemistry: Supports academic and industrial research focused on the synthesis, characterization, and behavior of Atorvastatin-related substances.

Basic Information

Product Name	Allyl Ester Of Atorvastatin Cyclic (Isopropyl) Impurity
CAS No.	1316295-72-3
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Atorvastatin Allyl Ester Cyclic Isopropyl Impurity; Atorvastatin Impurity (Allyl Ester, Cyclic Isopropyl); Atorvastatin Related Compound; (Isopropyl)-allyl ester of Atorvastatin cyclic impurity; Atorvastatin Process Impurity; Atorvastatin Degradant; 1316295-72-3; Allyl Ester of Atorvastatin Cyclic Isopropyl Derivative
EINECS	Contact for details

Quality Control

Every batch of our Allyl Ester Of Atorvastatin Cyclic (Isopropyl) Impurity is manufactured and analyzed under strict quality systems. Our products undergo rigorous identity confirmation, purity assay, and impurity profiling using advanced analytical techniques such as HPLC, LC-MS, and NMR to ensure they meet the exacting standards required for pharmaceutical analysis. A comprehensive Certificate of Analysis (COA) detailing purity, chromatographic data, and spectroscopic results is provided with each shipment to support your regulatory and quality needs.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as specified on the 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 (IR)	Conforms
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Meets requirement
Residual Solvents (GC)	Meets ICH guidelines

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