Description

Atorvastatin Impurity 22 CAS NO 1821498-27-4 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 analysis. It is an essential material for analytical chemists, quality assurance laboratories, and research institutions focused on method development and validation.

Application

• Pharmaceutical Reference Standard: Serves as a certified reference material for the identification and quantification of Atorvastatin Impurity 22 in active pharmaceutical ingredients (APIs) and finished drug products.
• Analytical Method Development: Used to develop, optimize, and validate chromatographic methods (HPLC, UPLC) for impurity profiling in compliance with ICH Q3A(R2) and Q3B(R2) guidelines.
• Quality Control & Assurance: Critical for routine batch testing in QC laboratories to monitor impurity levels and ensure product specifications are met.
• Stability Studies: Employed as a marker in forced degradation and long-term stability studies to understand the degradation pathways of Atorvastatin.
• Regulatory Submissions: Provides necessary data for regulatory filings (e.g., with FDA, EMA) to demonstrate thorough impurity characterization and control.
• Research & Development: Used in synthetic chemistry research to study the formation, fate, and purge of this specific impurity during the API manufacturing process.

Basic Information

Product Name	Atorvastatin Impurity 22
CAS No.	1821498-27-4
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Atorvastatin Related Compound 22; Atorvastatin EP Impurity J; Atorvastatin USP Impurity 22; (3R,5R)-7-[2-(4-Fluorophenyl)-3-phenyl-4-(phenylcarbamoyl)-5-(propan-2-yl)-1H-pyrrol-1-yl]-3,5-dihydroxyheptanoic acid (IUPAC); Atorvastatin Lactone Dimer; Atorvastatin Process Impurity; Atorvastatin Degradant
EINECS	Contact for details

Quality Control

Every batch of Atorvastatin Impurity 22 is manufactured and tested under strict quality management systems. Our products undergo rigorous analytical testing, including HPLC, NMR, and MS, to ensure identity, purity, and conformity with in-house specifications and relevant pharmacopeial standards. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results.

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.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Conforms
Identification (MS)	Conforms
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual unknown impurity ≤ 0.5% Total impurities ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 5.0%

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