Description

Atorvastatin Related Compound A is a high-purity chemical reference standard, essential for pharmaceutical research and development. This compound serves as a critical impurity marker in the quality control and validation of Atorvastatin, a leading cholesterol-lowering medication. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies to ensure drug safety, efficacy, and compliance with stringent pharmacopeial standards.

Application

• Pharmaceutical Impurity Profiling: Used as a certified reference material (CRM) for the identification and quantification of specific impurities in Atorvastatin Active Pharmaceutical Ingredient (API) and finished dosage forms.
• Analytical Method Development & Validation: A critical component in developing and validating High-Performance Liquid Chromatography (HPLC) and other chromatographic methods for Atorvastatin analysis.
• Quality Control (QC) & Quality Assurance (QA): Employed in routine batch testing within pharmaceutical QC laboratories to monitor impurity levels and ensure product consistency against ICH guidelines.
• Regulatory Compliance & Submission: Supports regulatory filings (e.g., for FDA, EMA) by providing necessary data on impurity characterization and control strategies.
• Stability Studies: Used as a benchmark to track the formation of degradation products in Atorvastatin formulations under various stress conditions.
• Research & Development: Facilitates process chemistry research aimed at optimizing synthesis routes to minimize the formation of this related compound.

Basic Information

Product Name	Atorvastatin Related Compound A
CAS No.	433289-83-9
Molecular Formula	C33H35FN2O5
Molecular Weight	558.65 g/mol
Synonyms	Atorvastatin Impurity A; (3R,5R)-7-[2-(4-Fluorophenyl)-5-(1-methylethyl)-3-phenyl-4-(phenylcarbamoyl)-1H-pyrrol-1-yl]-3,5-dihydroxyheptanoic Acid; Atorvastatin EP Impurity A; Atorvastatin USP Related Compound A; Atorvastatin Lactone Dimer; Atorvastatin Dimer Lactone
EINECS	Contact for details

Quality Control

Our Atorvastatin Related Compound A is manufactured under strict quality systems and undergoes rigorous analytical testing to ensure it meets the highest standards for pharmaceutical reference materials. Each batch is characterized and tested for identity, purity, and impurities using validated methods such as HPLC, NMR, and Mass Spectrometry. A comprehensive Certificate of Analysis (COA) is provided, detailing all test results and confirming compliance with relevant pharmacopeial guidelines (e.g., USP, EP).

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15-25°C, in a dry environment. Handle and store in accordance with good laboratory practices 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)	≥ 98.0%
Related Substances (HPLC)	Individual impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%

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