Description

Clopidogrel Impurity 4 is a high-purity reference standard used in the pharmaceutical development and quality control of the antiplatelet drug Clopidogrel. This compound is critical for ensuring the safety and efficacy of the final drug product by enabling the accurate identification, quantification, and control of this specific impurity. It is an essential material for analytical laboratories, research institutions, and pharmaceutical manufacturers engaged in method validation, stability studies, and regulatory compliance. The reliable supply of this well-characterized impurity standard is fundamental to maintaining the highest standards in pharmaceutical quality assurance.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of Clopidogrel Impurity 4 in active pharmaceutical ingredients (API) and finished drug products.
• Analytical Method Development & Validation: Critical for developing and validating sensitive and specific analytical methods, such as HPLC and LC-MS, for impurity profiling.
• Quality Control & Batch Release: Used in routine QC testing to ensure Clopidogrel batches comply with stringent pharmacopeial limits (e.g., USP, EP, ICH Q3A/B) for specified impurities.
• Stability Studies: Employed to monitor the formation and growth of this impurity over time under various storage conditions, supporting shelf-life determination.
• Regulatory Submissions: Essential for preparing regulatory documentation (e.g., for FDA, EMA) to demonstrate control strategies for drug substance and product impurities.
• Research & Process Chemistry: Used by chemists to study impurity formation pathways and to optimize synthesis and purification processes to minimize its presence.

Basic Information

Product Name	Clopidogrel Impurity 4
CAS No.	801319-16-4
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; Clopidogrel EP Impurity C; Clopidogrel USP Related Compound C; Methyl (2S)-2-(2-chlorophenyl)-2-(4,5,6,7-tetrahydrothieno[3,2-c]pyridin-5-yl)acetate; Clopidogrel Process Impurity; 5H-Thieno[3,2-c]pyridine, 6,7-dihydro-, 5-[(2S)-2-(2-chlorophenyl)-2-methoxy-2-oxoethyl]-
EINECS	Contact for details

Quality Control

Our Clopidogrel Impurity 4 is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including HPLC purity assay, identification by spectroscopic methods (IR, NMR, MS), and control of related substances and residual solvents, to ensure it meets the exacting standards required for pharmaceutical reference materials. Certificates of Analysis (COA) containing detailed test results and traceability information are provided with every shipment. Our quality commitment aligns with ICH guidelines and supports compliance with global regulatory expectations.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label or COA. This material is hygroscopic (moisture-sensitive) and must be kept in a dry environment. For long-term storage, consider storing under an inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual impurity ≤ 1.0%
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.