Description

Clopidogrel Ep Impurity B Hcl is a high-purity chemical reference standard, specifically identified as a key impurity in the synthesis and quality control of the antiplatelet drug Clopidogrel. This compound is critical for pharmaceutical manufacturers and analytical laboratories to ensure drug safety, efficacy, and regulatory compliance by accurately monitoring and controlling impurity profiles. It is an essential material for research and development, method validation, and routine quality testing in the pharmaceutical industry.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of Clopidogrel Ep Impurity B in active pharmaceutical ingredients (APIs) and finished drug products.
• Analytical Method Development & Validation: Essential for developing, optimizing, and validating HPLC, UPLC, or LC-MS methods to separate and analyze impurities in Clopidogrel.
• Quality Control & Assurance (QC/QA): Employed in routine batch release testing to ensure Clopidogrel API and formulations meet stringent pharmacopeial (e.g., USP, EP, ICH) impurity limits.
• Stability Studies: Used to monitor the formation of this specific degradation product under various stress conditions (e.g., heat, light, humidity) as per ICH guidelines.
• Regulatory Submissions: Provides critical data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs) to demonstrate control over the manufacturing process.
• Process Chemistry Research: Aids in understanding and optimizing the Clopidogrel synthesis pathway to minimize the formation of this impurity.

Basic Information

Product Name	Clopidogrel Ep Impurity B Hcl
CAS No.	1396607-35-4
Molecular Formula	C15H15ClNO2S.HCl
Molecular Weight	352.26 g/mol (for free base: 316.80)
Synonyms	Clopidogrel EP Impurity B Hydrochloride; Clopidogrel Related Compound B HCl; (S)-Methyl 2-(2-chlorophenyl)-2-(6,7-dihydrothieno[3,2-c]pyridin-5(4H)-yl)acetate hydrochloride; Methyl (2S)-2-(2-chlorophenyl)-2-(4,5,6,7-tetrahydrothieno[3,2-c]pyridin-5-yl)acetate hydrochloride; Clopidogrel Impurity B (HCl Salt); Clopidogrel EP Imp B HCl
EINECS	Contact for details

Quality Control

Every batch of Clopidogrel Ep Impurity B Hcl is manufactured and analyzed under strict quality management systems. The product undergoes rigorous identity confirmation, purity assessment, and impurity profiling using advanced analytical techniques such as HPLC, LC-MS, NMR, and IR spectroscopy to ensure it meets the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results and confirming compliance with relevant specifications.

Storage

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

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Assay (HPLC)	≥ 95.0%
Purity (HPLC, Area %)	≥ 98.0%
Single Unknown Impurity	≤ 1.0%
Total Impurities	≤ 2.0%
Water Content (KF)	≤ 5.0%
Residue on Ignition	≤ 0.5%

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