Description

Clopidogrel Impurity 7 is a high-purity reference standard used in the analytical profiling and quality control of the antiplatelet drug Clopidogrel. This compound is critical for pharmaceutical manufacturers and analytical laboratories to ensure drug safety, efficacy, and regulatory compliance by accurately identifying and quantifying this specific impurity. It is an essential material for research and development, method validation, and stability studies within the pharmaceutical industry.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material for the identification and quantification of Clopidogrel Impurity 7 in active pharmaceutical ingredients (API) and finished drug products.
• Analytical Method Development & Validation: Critical for developing, optimizing, and validating HPLC, UPLC, or LC-MS methods for impurity profiling.
• Quality Control & Assurance (QC/QA): Used in routine batch testing to monitor impurity levels and ensure they remain within ICH (International Council for Harmonisation) specified limits.
• Stability Studies: Employed to track the formation of this impurity over time under various stress conditions (e.g., heat, humidity, light) to establish product shelf life.
• Regulatory Submissions: Provides essential data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs) to meet FDA, EMA, and other global health authority requirements.
• Research on Degradation Pathways: Serves as a key marker in studies to understand the degradation mechanisms of Clopidogrel.

Basic Information

Product Name	Clopidogrel Impurity 7
CAS No.	444728-13-6
Molecular Formula	C15H14ClNO2S
Molecular Weight	307.79 g/mol
Synonyms	Clopidogrel Related Compound 7; (S)-Methyl 2-(2-chlorophenyl)-2-(6,7-dihydrothieno[3,2-c]pyridin-5(4H)-yl)acetate; Methyl (2S)-2-(2-chlorophenyl)-2-(4H,5H,6H,7H-thieno[3,2-c]pyridin-5-yl)acetate; Clopidogrel EP Impurity G; Clopidogrel USP Impurity; Clopidogrel Process Impurity; 5H-Thieno[3,2-c]pyridine, 6,7-dihydro-, 5-[(2S)-2-(2-chlorophenyl)-2-(methoxycarbonyl)ethyl]-
EINECS	Contact for details

Quality Control

Our Clopidogrel Impurity 7 is manufactured under strict quality systems and undergoes rigorous analytical testing to ensure identity, purity, and consistency. Each batch is supplied with a comprehensive Certificate of Analysis (COA) detailing results from HPLC, NMR, and MS analyses. The quality standards are designed to meet the requirements for use as a pharmaceutical reference standard in compliance with ICH guidelines.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). Due to its hygroscopic (moisture-sensitive) nature, the container must be kept tightly sealed in a dry environment to prevent degradation. For long-term storage, consider storing under an inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time corresponds to reference standard
Identification (IR)	Spectrum matches reference spectrum
Purity (HPLC, Area %)	≥ 98.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 0.10% Total impurities: ≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 0.5%

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