Description

Clopidogrel Impurity 15 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 active pharmaceutical ingredient (API) Clopidogrel, a widely prescribed antiplatelet medication. It is an essential material for pharmaceutical R&D laboratories, quality assurance departments, and manufacturers engaged in the development and production of Clopidogrel-based formulations.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material for the identification and quantification of impurities in Clopidogrel API and finished drug products.
• Method Development & Validation: Crucial for developing and validating analytical methods, such as HPLC and UPLC, to monitor impurity profiles in compliance with ICH guidelines.
• Quality Control & Assurance (QC/QA): Used in routine batch testing to ensure Clopidogrel meets stringent pharmacopeial specifications (e.g., USP, EP) for impurity limits.
• Stability Studies: Employed to track the formation of degradation products under various stress conditions to determine drug shelf-life and storage requirements.
• Regulatory Submissions: Supports the preparation of regulatory documentation (e.g., for FDA, EMA) by providing characterized impurity data for drug master files (DMFs) and marketing applications.
• Research & Development: Facilitates process chemistry research to understand and minimize the formation of this specific impurity during API synthesis.

Basic Information

Product Name	Clopidogrel Impurity 15
CAS No.	1225166-78-8
Molecular Formula	C15H14ClNO2S
Molecular Weight	307.79 g/mol
Synonyms	Clopidogrel Related Compound 15; (S)-Methyl 2-(2-chlorophenyl)-2-(6,7-dihydrothieno[3,2-c]pyridin-5(4H)-yl)acetate; Methyl (2S)-2-(2-chlorophenyl)-2-(4,5,6,7-tetrahydrothieno[3,2-c]pyridin-5-yl)acetate; Clopidogrel EP Impurity G; Clopidogrel USP Impurity; Clopidogrel Process Impurity; 5H-Thieno[3,2-c]pyridine-5-acetic acid, α-(2-chlorophenyl)-, methyl ester, (αS)-
EINECS	Contact for details

Quality Control

Every batch of Clopidogrel Impurity 15 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and assay testing using advanced chromatographic (HPLC, GC) and spectroscopic (NMR, MS) techniques to ensure compliance with pharmacopeial standards. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results, and is available upon request.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). Due to its hygroscopic (moisture-sensitive) nature, the container should be kept in a desiccated environment. For long-term storage, consider storing under an inert atmosphere.

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)	Single unknown impurity ≤ 0.5% Total impurities ≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 1.0%
Assay	97.0% - 103.0% (on anhydrous basis)

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