Description

Clopidogrel Impurity C is a designated pharmaceutical reference standard used for analytical and quality control purposes. This compound is critical for ensuring the purity, safety, and efficacy of the antiplatelet drug Clopidogrel bisulfate during its development and manufacturing. It is primarily required by pharmaceutical companies, analytical laboratories, and regulatory bodies for method validation, impurity profiling, and batch release testing.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the identification and quantification of Clopidogrel Impurity C in active pharmaceutical ingredients (APIs) and finished drug products.
• Analytical Method Development & Validation: Essential for developing, optimizing, and validating chromatographic methods (e.g., HPLC, UPLC) to monitor impurities.
• Quality Control & Batch Release: Used in routine QC testing of Clopidogrel bisulfate to ensure compliance with pharmacopeial specifications (e.g., USP, EP, ICH Q3A/B guidelines).
• Stability Studies: Employed to track the formation of this specific impurity over time under various stress conditions to determine drug shelf life.
• Regulatory Submissions: Critical for preparing regulatory documentation (e.g., CMC sections for FDA, EMA) to demonstrate comprehensive impurity control strategies.
• Research & Development: Used in synthetic chemistry R&D to understand and minimize the formation of this impurity during the API manufacturing process.

Basic Information

Product Name	Clopidogrel Impurity C
CAS No.	1346605-15-9
Molecular Formula	C15H14ClNO2S
Molecular Weight	307.79 g/mol
Synonyms	Clopidogrel Related Compound C; (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 C; Clopidogrel USP Impurity C; Clopidogrel Process Impurity; Clopidogrel Intermediate Derivative
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 characterized and controlled against pharmacopeial standards where applicable. A comprehensive Certificate of Analysis (COA) is provided, detailing purity, identity, and impurity profile as determined by validated methods (HPLC, NMR, MS).

Storage

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

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)	Individual unknown impurity: ≤ 0.5% 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.