Description

Atorvastatin Impurity 20 is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and regulatory compliance of Atorvastatin, a leading cholesterol-lowering medication. It is primarily utilized by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and impurity profiling. The availability of this well-characterized impurity is essential for maintaining the stringent quality control standards required in modern pharmaceutical production.

Application

• Pharmaceutical Impurity Profiling: Used as a certified reference material for the identification and quantification of specific impurities in Atorvastatin Active Pharmaceutical Ingredient (API) and finished dosage forms.
• Analytical Method Development & Validation: Serves as a critical standard for developing and validating HPLC, UPLC, or LC-MS methods to ensure accurate impurity detection.
• Quality Control & Assurance (QC/QA): Employed in routine quality control testing to monitor impurity levels and ensure batch-to-batch consistency of Atorvastatin.
• Regulatory Compliance & Submissions: Essential for preparing regulatory documentation (e.g., for FDA, EMA) to demonstrate thorough impurity characterization and control strategies.
• Stability Studies: Used to identify and track degradation products that may form in Atorvastatin formulations under various storage conditions.
• Research & Development: Supports pharmaceutical R&D in understanding the degradation pathways and chemical behavior of Atorvastatin.

Basic Information

Item	Detail
Product Name	Atorvastatin Impurity 20
CAS No.	1016893-70-1
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Atorvastatin Related Compound 20; Atorvastatin EP Impurity J; Atorvastatin USP Related Compound J; (3R,5R)-7-[2-(4-Fluorophenyl)-5-(1-methylethyl)-3-phenyl-4-[(phenylamino)carbonyl]-1H-pyrrol-1-yl]-3,5-dihydroxyheptanoic Acid; Atorvastatin Amide Impurity; Atorvastatin Process Impurity; Atorvastatin Degradant
EINECS	Contact for details

Quality Control

Every batch of Atorvastatin Impurity 20 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous testing to ensure compliance with relevant pharmacopeial standards (e.g., USP, EP) and customer-specific requirements. Comprehensive characterization, including identification by spectroscopic methods and purity determination by HPLC, is performed. A detailed Certificate of Analysis (COA) is provided with each shipment, confirming identity, purity, and analytical data.

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 should be handled in a dry environment to prevent degradation. For long-term storage, consider desiccated conditions.

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)	Individual unknown impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Residual Solvents (GC)	Complies with ICH guidelines
Water Content (KF)	≤ 5.0%

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