Description

Atorvastatin Impurity 118 is a high-purity chemical reference standard used in the analytical development and quality control of the active pharmaceutical ingredient (API) atorvastatin. This compound is critical for ensuring the safety, efficacy, and regulatory compliance of atorvastatin-based medications by enabling the accurate identification and quantification of process-related impurities. It is an essential tool for pharmaceutical manufacturers, contract research organizations (CROs), and analytical laboratories engaged in method validation, stability studies, and regulatory submissions.

Application

• Pharmaceutical Impurity Profiling: Serves as a certified reference material for the identification and quantification of specific impurities in atorvastatin API and finished dosage forms.
• Analytical Method Development & Validation: Used as a critical standard to develop, optimize, and validate HPLC, UPLC, or LC-MS methods for impurity detection.
• Quality Control (QC) & Quality Assurance (QA): Employed in routine batch release testing to monitor and control impurity levels, ensuring compliance with ICH Q3A(R2) and Q3B(R2) guidelines.
• Stability Studies: Utilized to track the formation of degradation products in atorvastatin formulations under various stress conditions (e.g., heat, light, humidity).
• Regulatory Documentation: Provides essential data for Drug Master Files (DMFs), Investigational New Drug (IND) applications, and New Drug Applications (NDAs).
• Research & Development: Aids in understanding the synthetic pathway and degradation mechanisms of atorvastatin during process chemistry R&D.

Basic Information

Product Name	Atorvastatin Impurity 118
CAS No.	2125501-02-0
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Atorvastatin Related Compound 118; Atorvastatin EP Impurity 118; Atorvastatin USP Impurity 118; (3R,5R)-7-[2-(4-Fluorophenyl)-3-phenyl-4-(phenylcarbamoyl)-5-(propan-2-yl)-1H-pyrrol-1-yl]-3,5-dihydroxyheptanoic acid Impurity; Atorvastatin Process Impurity; Atorvastatin Degradant
EINECS	Contact for details

Quality Control

Every batch of Atorvastatin Impurity 118 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous quality testing, including advanced chromatographic and spectroscopic techniques, to ensure identity, purity, and consistency. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results for purity, impurities, and other critical parameters. We support compliance with ICH, USP, and EP guidelines for pharmaceutical impurities.

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 (HPLC)	Retention time matches reference standard
Identification (IR)	Spectrum conforms to reference spectrum
Purity (HPLC)	≥ 95.0%
Single Unknown Impurity (HPLC)	≤ 1.0%
Total Impurities (HPLC)	≤ 5.0%
Water Content (KF)	≤ 5.0%

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