Description

Atorvastatin Impurity 28 is a high-purity chemical reference standard used in pharmaceutical research and development. This compound is critical for the quality control and regulatory compliance of Atorvastatin, a widely prescribed cholesterol-lowering medication. It is primarily required by analytical laboratories, pharmaceutical manufacturers, and regulatory bodies for method development, validation, and impurity profiling studies to ensure drug safety and efficacy.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the qualitative and quantitative analysis of Atorvastatin drug substance and finished products.
• Impurity Profiling and Identification: Essential for identifying, characterizing, and quantifying process-related impurities and degradation products in Atorvastatin during stability studies.
• Analytical Method Development and Validation: Serves as a critical component in developing and validating HPLC, UPLC, or LC-MS methods for impurity detection and separation.
• Quality Control (QC) Testing: Employed in routine QC laboratories to monitor impurity levels against International Council for Harmonisation (ICH) guidelines and pharmacopeial standards (USP, EP).
• Regulatory Submissions: Provides necessary data for regulatory filings (e.g., with FDA, EMA) to demonstrate thorough understanding and control of the drug's impurity profile.
• Stability Studies: Used to track the formation of specific impurities under various stress conditions (heat, light, humidity) as part of drug product stability testing.

Basic Information

Product Name	Atorvastatin Impurity 28
CAS No.	1403667-07-1
Molecular Formula	C33H35FN2O5
Molecular Weight	558.65 g/mol
Synonyms	(3R,5R)-7-[2-(4-Fluorophenyl)-5-(1-methylethyl)-3-phenyl-4-(phenylcarbamoyl)-1H-pyrrol-1-yl]-3,5-dihydroxyheptanoic Acid; Atorvastatin EP Impurity M; Atorvastatin Related Compound M; Atorvastatin Carboxylic Acid Derivative; Atorvastatin Process Impurity; (βR,δR)-2-(4-Fluorophenyl)-β,δ-dihydroxy-5-(1-methylethyl)-3-phenyl-4-[(phenylamino)carbonyl]-1H-pyrrole-1-heptanoic Acid
EINECS	Contact for details

Quality Control

Every batch of Atorvastatin Impurity 28 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity testing using advanced chromatographic (HPLC, UPLC) and spectroscopic (NMR, MS) techniques to ensure compliance with pharmacopeial standards and customer specifications. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label. This material is hygroscopic (moisture-sensitive) and should be handled in a dry environment to maintain stability and purity.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time corresponds to reference standard
Identification (IR)	Spectrum matches reference spectrum
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0% Any individual unknown impurity ≤ 1.0%
Water Content (KF)	≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines

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