Description

Atorvastatin Impurity 15 is a high-purity chemical reference standard, specifically identified as a process-related impurity of the widely prescribed cholesterol-lowering drug, Atorvastatin. This compound is critical for pharmaceutical research and development, enabling precise analytical method development, validation, and quality control to ensure drug safety and efficacy. It is an essential material for analytical chemists, quality assurance laboratories, and regulatory affairs professionals within the global pharmaceutical and contract research organization (CRO) sectors.

Application

• Pharmaceutical Impurity Profiling and Characterization: Used as a certified reference material (CRM) to identify and quantify this specific impurity in Atorvastatin active pharmaceutical ingredient (API) and finished dosage forms.
• Analytical Method Development and Validation: Serves as a critical standard for developing, optimizing, and validating HPLC, UPLC, and LC-MS methods to meet ICH Q2(R1) guidelines.
• Stability Studies and Forced Degradation Testing: Employed to monitor the formation of this impurity under various stress conditions (e.g., heat, light, humidity) as part of drug stability assessment.
• Quality Control and Batch Release Testing: Essential for setting specification limits and conducting routine QC testing of Atorvastatin batches to ensure compliance with pharmacopeial standards (USP, EP).
• Regulatory Submissions: Provides necessary data and reference samples for regulatory filings (e.g., ANDA, NDA) to demonstrate thorough impurity control strategies to agencies like the FDA and EMA.
• Research on Degradation Pathways: Aids in studying the chemical degradation mechanisms of Atorvastatin, helping to improve formulation and packaging strategies.

Basic Information

Product Name	Atorvastatin Impurity 15
CAS No.	693793-42-9
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 J; Atorvastatin USP Related Compound J; Atorvastatin Lactone Dimer; Atorvastatin Dimer Impurity; Atorvastatin Related Substance J; (βR,δR)-2-(4-Fluorophenyl)-β,δ-dihydroxy-5-(1-methylethyl)-3-phenyl-4-[(phenylamino)carbonyl]-1H-pyrrole-1-heptanoic acid dimer
EINECS	Contact for details

Quality Control

Every batch of Atorvastatin Impurity 15 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity confirmation, purity assay, and impurity profiling using advanced techniques like HPLC, LC-MS, and NMR to ensure compliance with pharmacopeial and ICH guidelines. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results for purity, related substances, residual solvents, and other critical parameters.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15-25°C, in a dry environment. This material is hygroscopic (moisture-sensitive) and should be handled under anhydrous conditions 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 unknown impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Water Content (KF)	≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C

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