Description

Clopidogrel Impurity C is a critical pharmaceutical reference standard used for quality control and analytical method development. This compound is essential for ensuring the purity, safety, and efficacy of the widely prescribed antiplatelet drug, Clopidogrel bisulfate. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for impurity profiling, method validation, and stability studies.

Application

• Pharmaceutical Impurity Profiling: Used as a certified reference material to identify, quantify, and monitor this specific impurity in Clopidogrel active pharmaceutical ingredient (API) and finished dosage forms.
• Analytical Method Development & Validation: Serves as a critical standard for developing and validating HPLC, UPLC, and other chromatographic methods to ensure accurate impurity detection.
• Quality Control & Assurance (QC/QA): Employed in routine quality control testing to ensure Clopidogrel batches comply with stringent pharmacopeial limits (e.g., USP, EP, ICH guidelines) for related substances.
• Stability Studies: Used to assess the formation of degradation products under various stress conditions, supporting drug shelf-life determination.
• Regulatory Submissions: Provides essential data for regulatory filings (e.g., ANDA, NDA) to demonstrate comprehensive impurity control strategies to agencies like the FDA and EMA.
• Research & Development: Facilitates research into the synthesis, degradation pathways, and toxicological profile of Clopidogrel and its related compounds.

Basic Information

Product Name	Clopidogrel Impurity C
CAS No.	120202-69-9
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 C; (S)-Clopidogrel Carboxylic Acid Methyl Ester; Clopidogrel Methyl Ester; Clopidogrel Impurity 3; SR 25989 Impurity; (S)-α-(2-Chlorophenyl)-6,7-dihydrothieno[3,2-c]pyridine-5(4H)-acetic Acid Methyl Ester
EINECS	Contact for details

Quality Control

Our Clopidogrel Impurity C is manufactured under strict quality systems and undergoes rigorous analytical testing to ensure it meets the high standards required for pharmaceutical reference materials. Each batch is supplied with a comprehensive Certificate of Analysis (COA) detailing purity, identity, and impurity profiles. We support compliance with ICH Q3A/B, USP, and EP guidelines, and our quality commitment ensures reliable and consistent performance for your critical applications.

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 product is hygroscopic (moisture-sensitive) and should be handled in a dry environment 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)	Total impurities ≤ 2.0% Any individual unknown impurity ≤ 0.5%
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.