Description

Atorvastatin Impurity 31 is a high-purity chemical reference standard used in the pharmaceutical development and quality control processes. This compound is critical for ensuring the safety and efficacy of Atorvastatin, a widely prescribed cholesterol-lowering medication, by enabling accurate identification and quantification of related substances. It is an essential material for analytical chemists and quality assurance professionals in pharmaceutical R&D and manufacturing.

Application

• Primary use as a certified reference standard for analytical method development and validation.
• Critical component for impurity profiling and characterization in Atorvastatin Active Pharmaceutical Ingredient (API) batches.
• Used in stability studies to monitor degradation pathways and establish shelf-life specifications.
• Essential for regulatory compliance and filing, supporting ICH guidelines on impurities in new drug substances (Q3A(R2)).
• Calibration standard for High-Performance Liquid Chromatography (HPLC) and Liquid Chromatography-Mass Spectrometry (LC-MS) systems.
• Supports pharmacopoeial testing to meet USP, EP, or other compendial requirements for impurity limits.

Basic Information

Product Name	Atorvastatin Impurity 31
CAS No.	1173184-78-5
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Atorvastatin Related Compound 31; Atorvastatin EP Impurity I; Atorvastatin USP Impurity; (3R,5R)-7-[2-(4-Fluorophenyl)-3-phenyl-4-(phenylcarbamoyl)-5-(propan-2-yl)-1H-pyrrol-1-yl]-3,5-dihydroxyheptanoic acid Impurity; Atorvastatin Degradation Product; Atorvastatin Process Impurity; Atorvastatin Specified Impurity
EINECS	Contact for details

Quality Control

Every batch of Atorvastatin Impurity 31 is manufactured under strict quality management systems and undergoes comprehensive analytical characterization. Our products are supplied with a detailed Certificate of Analysis (COA) that includes data from HPLC purity, related substance analysis, and spectroscopic identification (IR, NMR, MS). We support compliance with ICH guidelines and relevant pharmacopoeial standards (USP, EP). Certificates of Analysis are 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 solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0%
Water Content (KF)	≤ 5.0%
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.