Description

Clopidogrel Impurity 18 is a designated reference standard used in the analytical profiling and quality control of the active pharmaceutical ingredient, Clopidogrel. This compound is critical for pharmaceutical manufacturers and analytical laboratories to ensure product purity, safety, and regulatory compliance. It is primarily utilized in research and development, method validation, and stability studies for cardiovascular drugs.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the identification and quantification of related substances in Clopidogrel API and finished dosage forms.
• Analytical Method Development & Validation (HPLC/LC-MS): Essential for developing, calibrating, and validating chromatographic methods to monitor impurity profiles.
• Quality Control & Assurance (QC/QA): Used in routine batch testing to ensure Clopidogrel meets stringent pharmacopeial specifications (e.g., USP, EP, ICH Q3A/B).
• Stability Studies: Employed to track the formation of degradation products under various stress conditions, supporting shelf-life determination.
• Regulatory Submissions: Provides necessary impurity characterization data for drug master files (DMFs), ANDAs, and other regulatory documentation for global markets.
• Research & Development: Aids in understanding the synthetic pathway, degradation routes, and metabolic profile of Clopidogrel.

Basic Information

Product Name	Clopidogrel Impurity 18
CAS No.	808732-86-7
Molecular Formula	C15H14ClNO2S
Molecular Weight	307.80 g/mol
Synonyms	Clopidogrel Related Compound 18; Clopidogrel EP Impurity G; Methyl (2S)-2-(2-chlorophenyl)-2-[(4,5,6,7-tetrahydrothieno[3,2-c]pyridin-5-yl)acetate] hydrochloride; (S)-Clopidogrel Carboxylic Acid Impurity; Clopidogrel Acid Impurity; 5-[(2S)-2-(2-Chlorophenyl)-2-methoxy-2-oxoethyl]-4,5,6,7-tetrahydrothieno[3,2-c]pyridin-5-ium chloride
EINECS	Contact for details

Quality Control

Our Clopidogrel Impurity 18 is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC purity assay, identity confirmation (IR, MS), and residual solvent analysis, to ensure compliance with pharmacopeial standards. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with every shipment to support your quality and regulatory requirements.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, 15-25°C (59-77°F), in a dry environment. The material is hygroscopic (moisture-sensitive); ensure the container is sealed after each use to prevent degradation.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time corresponds to reference standard
Identification (IR)	Spectrum matches reference spectrum
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual unknown impurity ≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 1.0% w/w

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