Description

Atorvastatin Impurity 40 is a high-purity chemical reference standard used in the pharmaceutical development and quality control of Atorvastatin, a leading cholesterol-lowering 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 pharmaceutical impurity profiling and method validation.

Application

• Pharmaceutical Reference Standard: Serves as a certified standard for the identification and quantification of Atorvastatin Impurity 40 in active pharmaceutical ingredients (API) and finished drug products.
• Analytical Method Development & Validation: 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 (QC/QA): Critical for routine batch release testing to monitor impurity levels and ensure product consistency and purity specifications are met.
• Stability Studies: Employed in forced degradation and long-term stability studies to track the formation of this specific impurity under various stress conditions.
• Regulatory Submissions: Provides necessary data and characterization for regulatory filings (e.g., ANDA, NDA) to demonstrate thorough impurity control strategies to agencies like the FDA and EMA.
• Research & Development (R&D): Used in synthetic chemistry research to understand impurity formation pathways and to develop robust purification processes for Atorvastatin.

Basic Information

Product Name	Atorvastatin Impurity 40
CAS No.	1116118-82-1
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Atorvastatin Related Compound 40; Atorvastatin EP Impurity J; Atorvastatin USP Related Compound; (3R,5R)-7-[2-(4-Fluorophenyl)-5-(1-methylethyl)-3-phenyl-4-(phenylcarbamoyl)-1H-pyrrol-1-yl]-3,5-dihydroxyheptanoic acid (specific isomer); Atorvastatin Lactone Dimer; Atorvastatin Process Impurity; Atorvastatin Degradant
EINECS	Contact for details

Quality Control

Every batch of Atorvastatin Impurity 40 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity testing using advanced analytical techniques such as HPLC, GC, NMR, and MS to ensure compliance with pharmacopeial standards (USP, EP) and customer-specific requirements. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment to guarantee traceability and support your regulatory needs.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label or COA. Keep the container in a dry, cool, and well-ventilated area. Handle and store in accordance with good laboratory practices.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Conforms
Identification (NMR/IR)	Conforms
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual impurity: ≤ 1.0% 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.