Description

Clopidogrel Related Compound A (20 Mg) ((S)-(o-Chlorophenyl)-6,7-Dihydrothieno[3,2-C]Pyri-Dine-5(4H)-Acetic Acid, Hydrochloride) is a high-purity reference standard critical for pharmaceutical research and development. This compound is essential for ensuring the quality, safety, and efficacy of the widely used antiplatelet drug, clopidogrel bisulfate. It serves as a key analytical marker for pharmaceutical manufacturers, contract research organizations (CROs), and quality control laboratories involved in impurity profiling and method validation. The availability of this precisely characterized standard is fundamental for meeting stringent global regulatory requirements for active pharmaceutical ingredients (APIs).

Application

This high-grade reference material is indispensable in several critical pharmaceutical and analytical contexts:

• Pharmaceutical Impurity Profiling and Control: Used as a certified reference standard for the identification and quantification of specific impurities in clopidogrel API and finished dosage forms.
• Analytical Method Development and Validation (HPLC/LC-MS): Serves as a critical component for developing, optimizing, and validating stability-indicating assay methods in compliance with ICH guidelines.
• Quality Control and Batch Release Testing: Employed in routine QC laboratories to ensure clopidogrel products meet specified purity limits and regulatory standards (e.g., USP, EP, ICH Q3A/B).
• Stability Studies and Forced Degradation Testing: Acts as a benchmark for monitoring degradation pathways and establishing shelf-life specifications for clopidogrel-based medications.
• Regulatory Submissions and Compliance: Provides essential data for regulatory filings (e.g., ANDA, NDA) to demonstrate thorough impurity characterization and control strategies to agencies like the FDA and EMA.
• Research on Clopidogrel Metabolism and Pharmacology: Utilized in academic and industrial research settings to study the drug's pathways and related compound behavior.

Basic Information

Product Name	Clopidogrel Related Compound A (20 Mg) ((S)-(o-Chlorophenyl)-6,7-Dihydrothieno[3,2-C]Pyri-Dine-5(4H)-Acetic Acid, Hydrochloride)
CAS No.	144750-42-5
Molecular Formula	C16H16ClNO2S • HCl
Molecular Weight	358.28 g/mol (for free base: 321.82)
Synonyms	(S)-(+)-2-(2-Chlorophenyl)-2-(4,5,6,7-tetrahydrothieno[3,2-c]pyridin-5-yl)acetic acid hydrochloride; Clopidogrel Carboxylic Acid Hydrochloride; Clopidogrel Impurity A; Clopidogrel Related Substance A; SR 25989 Carboxylic Acid; (S)-α-(2-Chlorophenyl)-6,7-dihydrothieno[3,2-c]pyridine-5(4H)-acetic acid hydrochloride
EINECS	Contact for details

Quality Control

Our Clopidogrel Related Compound A is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including HPLC for purity and assay, IR and MS for structural confirmation, and stringent control of residual solvents and heavy metals. We provide a detailed Certificate of Analysis (COA) with each shipment, which includes batch-specific data, chromatograms, and traceability information. The material is suitable for use as a reference standard in methods aligned with USP, EP, and ICH guidelines.

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 product 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 reference spectrum
Identification (HPLC)	Retention time matches reference standard
Assay (HPLC)	≥ 98.0% (on anhydrous basis)
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual impurity ≤ 0.5%
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%
Heavy Metals	≤ 20 ppm

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