Description

Clopidogrel Related Compound B (20 Mg) (Methyl(+/-)-(o-Chlorophenyl)-4,5-Dihydrothieno[2,3-C]Pyridine-6(7H)-Acetate, Hydrochloride) is a high-purity chemical reference standard critical for pharmaceutical research and quality control. This compound is essential for the accurate identification and quantification of impurities in active pharmaceutical ingredients (APIs) and finished drug products. It is primarily used by analytical laboratories, R&D departments, and quality assurance teams within the pharmaceutical and biotechnology industries to ensure product safety, efficacy, and regulatory compliance.

Application

• Pharmaceutical Impurity Profiling and Control: Serves as a certified reference material for the identification and quantification of related substances in Clopidogrel API and its formulations.
• Analytical Method Development and Validation: Used as a critical standard to develop, optimize, and validate HPLC, UPLC, and GC methods for impurity analysis.
• Quality Control (QC) Testing: Employed in routine QC testing of bulk drug substances and finished dosage forms to monitor impurity levels against ICH guidelines.
• Regulatory Submissions: Provides essential data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs) to meet FDA, EMA, and other global health authority requirements.
• Stability Studies: Used as a marker to track the formation of degradation products during forced degradation and long-term stability studies of Clopidogrel products.
• Pharmacopeial Testing: Supports testing to comply with monographs in the United States Pharmacopeia (USP), European Pharmacopoeia (Ph. Eur.), and other pharmacopeias.

Basic Information

Product Name	Clopidogrel Related Compound B (20 Mg) (Methyl(+/-)-(o-Chlorophenyl)-4,5-Dihydrothieno[2,3-C]Pyridine-6(7H)-Acetate, Hydrochloride)
CAS No.	144750-52-7
Molecular Formula	C16H17Cl2NO2S
Molecular Weight	366.28 g/mol
Synonyms	Clopidogrel Impurity B; Clopidogrel Related Substance B; Methyl 2-(o-Chlorophenyl)-2-(4,5,6,7-tetrahydrothieno[3,2-c]pyridin-5-yl)acetate Hydrochloride; (o-Chlorophenyl)-4,5-Dihydrothieno[2,3-c]pyridine-6(7H)-Acetate Hydrochloride; Clopidogrel HCl Impurity B; SR 25989 Related Compound B; Plavix Impurity B
EINECS	Contact for details

Quality Control

Our Clopidogrel Related Compound B is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC purity assay, identification by IR and NMR spectroscopy, and residual solvent analysis, to ensure it meets the stringent requirements for pharmaceutical reference standards. A comprehensive Certificate of Analysis (COA) is supplied with each product, detailing batch-specific results, and is available for review to support your regulatory and quality needs.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, 15-25°C (59-77°F). The product is light-sensitive (store away from light).

Specification

Item	Specification
Appearance	White to off-white powder
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)	≤ 0.5%
Residue on Ignition	≤ 0.1%

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