Description

Clopidogrel Impurity 30 is a specified impurity and reference standard used in the analytical profiling of the antiplatelet drug Clopidogrel. This compound is critical for pharmaceutical research, development, and quality control, ensuring the safety and efficacy of the final drug product. It is primarily utilized by analytical laboratories, quality assurance departments, and R&D teams within the pharmaceutical and fine chemical industries for method validation, stability studies, and impurity identification.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the quantitative and qualitative analysis of Clopidogrel drug substances and products.
• Method Development and Validation: Essential for developing, validating, and transferring analytical methods, particularly High-Performance Liquid Chromatography (HPLC) and related techniques.
• Quality Control & Assurance: Employed in routine QC testing to monitor impurity levels, ensuring batches comply with stringent pharmacopeial limits (e.g., ICH Q3A/B).
• Stability Studies: Used to identify and quantify degradation products that may form during drug product storage and shelf-life studies.
• Regulatory Submissions: Provides necessary data for regulatory filings (e.g., with FDA, EMA) to demonstrate thorough impurity characterization and control.
• Process Chemistry Research: Aids in optimizing synthesis and purification processes by tracking the formation and removal of this specific impurity.

Basic Information

Product Name	Clopidogrel Impurity 30
CAS No.	131202-62-5
Molecular Formula	C15H14ClNO2S
Molecular Weight	307.80 g/mol
Synonyms	Methyl (2S)-2-(2-Chlorophenyl)-2-[(4,5,6,7-tetrahydrothieno[3,2-c]pyridin-5-yl)acetate]; Clopidogrel Related Compound 30; Clopidogrel EP Impurity G; Clopidogrel USP Impurity; (S)-Clopidogrel Carboxylic Acid Methyl Ester; 5-[(2S)-2-(2-Chlorophenyl)-2-methoxy-2-oxoethyl]-4,5,6,7-tetrahydrothieno[3,2-c]pyridine; Clopidogrel Methyl Ester Impurity
EINECS	Contact for details

Quality Control

Every batch of Clopidogrel Impurity 30 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous testing to ensure high purity and identity, aligning with ICH guidelines and relevant pharmacopeial standards. A comprehensive Certificate of Analysis (COA) detailing purity, assay, and impurity profile by validated methods (e.g., HPLC) is provided with each shipment to support your regulatory and quality requirements.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. The material is light-sensitive and should be handled accordingly to maintain stability.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual unspecified impurity ≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 0.5%

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