Description

Atorvastatin Cyclic Isopropyl Impurity is a high-purity chemical reference standard used in the pharmaceutical development and quality control of Atorvastatin, a leading statin medication. This impurity is critical for ensuring the safety, efficacy, and regulatory compliance of the final drug product by enabling accurate identification and quantification during analytical testing. It is an essential material for analytical chemists, quality assurance laboratories, and research institutions focused on pharmaceutical impurity profiling and method validation.

Application

• Pharmaceutical Impurity Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of the cyclic isopropyl impurity in Atorvastatin Active Pharmaceutical Ingredient (API) and finished dosage forms.
• Analytical Method Development and Validation: Serves as a critical component in developing, optimizing, and validating High-Performance Liquid Chromatography (HPLC) and other chromatographic methods for impurity profiling.
• Quality Control and Batch Release Testing: Employed in routine QC laboratories to monitor and control the levels of this specific impurity, ensuring every batch of Atorvastatin API meets stringent pharmacopeial specifications (e.g., USP, EP).
• Stability Studies and Forced Degradation Testing: Acts as a marker to understand the degradation pathways of Atorvastatin under various stress conditions (heat, light, humidity, acid/base).
• Regulatory Submissions and Compliance: Provides essential data for regulatory filings (e.g., with FDA, EMA) to demonstrate thorough impurity characterization and control strategies as per ICH Q3A and Q3B guidelines.
• Research and Development: Used in synthetic chemistry research to study the formation mechanism of this impurity and develop processes to minimize its generation.

Basic Information

Product Name	Atorvastatin Cyclic Isopropyl Impurity
CAS No.	873950-17-5
Molecular Formula	C39H38F2N2O5
Molecular Weight	676.73 g/mol
Synonyms	Atorvastatin Isopropyl Ester Impurity; Atorvastatin EP Impurity I; Atorvastatin Related Compound I; (3R,5R)-7-[2-(4-Fluorophenyl)-5-(1-methylethyl)-3-phenyl-4-(phenylcarbamoyl)-1H-pyrrol-1-yl]-3,5-dihydroxyheptanoic Acid; Atorvastatin Cyclic 1,1-Dimethylethyl Ester Impurity (Isomer); Atorvastatin Lactone Isopropyl Derivative; Atorvastatin Process Impurity
EINECS	Contact for details

Quality Control

Every batch of Atorvastatin Cyclic Isopropyl Impurity is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity profile testing using advanced analytical techniques such as HPLC, GC, NMR, and Mass Spectrometry to ensure compliance with pharmacopeial standards and customer specifications. Certificates of Analysis (COA) detailing batch-specific results are provided and traceable to certified reference standards.

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); the container must be kept tightly sealed in a dry environment to prevent degradation. For long-term storage, consider storing under an inert atmosphere.

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)	Total impurities ≤ 2.0% Any individual unknown impurity ≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 1.0% w/w
Heavy Metals	≤ 20 ppm

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