Description

Clopidogrel Impurity G is a specified impurity and a critical reference standard used in the quality control of the antiplatelet drug Clopidogrel bisulfate. This compound is essential for pharmaceutical manufacturers and analytical laboratories to ensure drug purity, safety, and regulatory compliance. It is primarily used by R&D scientists and QC professionals in the pharmaceutical industry for method development, validation, and routine batch testing.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in Clopidogrel bisulfate active pharmaceutical ingredient (API) and finished dosage forms.
• Analytical Method Development & Validation: Critical for developing and validating stability-indicating HPLC/UPLC methods to monitor impurity profiles throughout the drug product lifecycle.
• Quality Control & Batch Release: Employed in routine QC testing to ensure that Clopidogrel drug substances and products meet stringent pharmacopeial specifications (e.g., USP, EP, ICH Q3A/B).
• Stability Studies: Used to track the formation and level of this specific impurity during forced degradation and long-term stability studies of Clopidogrel formulations.
• Regulatory Submissions: Provides essential data for regulatory filings (e.g., ANDA, NDA, CMC sections) to demonstrate control over the impurity profile as per ICH guidelines.
• Research & Process Chemistry: Serves as a marker to optimize synthesis and purification processes, helping to minimize the formation of this impurity in the final API.

Basic Information

Product Name	Clopidogrel Impurity G
CAS No.	1357475-20-7
Molecular Formula	C15H14ClNO2S
Molecular Weight	307.79 g/mol
Synonyms	Clopidogrel Related Compound G; (S)-Methyl 2-(2-Chlorophenyl)-2-(6,7-dihydrothieno[3,2-c]pyridin-5(4H)-yl)acetate; Methyl (2S)-2-(2-chlorophenyl)-2-(4,5,6,7-tetrahydrothieno[3,2-c]pyridin-5-yl)acetate; Clopidogrel EP Impurity G; Clopidogrel USP Impurity G; Clopidogrel Process Impurity G
EINECS	Contact for details

Quality Control

Our Clopidogrel Impurity G is manufactured under strict quality systems and undergoes rigorous analytical testing to ensure high purity and batch-to-batch consistency. Each batch is supplied with a comprehensive Certificate of Analysis (COA) detailing results for identity, purity (by HPLC), and specified impurities. The material is suitable for use as a pharmaceutical reference standard in compliance with ICH, USP, and EP guidelines.

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.

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)	Any individual impurity: ≤ 0.5% Total impurities: ≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 0.5% w/w

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