Description

Clopidogrel Impurity 17 is a high-purity reference standard used in the analytical profiling and quality control of the active pharmaceutical ingredient (API) Clopidogrel. This compound is critical for pharmaceutical manufacturers and research laboratories to ensure product safety, efficacy, and regulatory compliance by accurately identifying and quantifying process-related impurities. It is an essential material for method development, validation, and stability studies within the pharmaceutical industry.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material for the identification and quantification of impurities in Clopidogrel API and finished dosage forms.
• Analytical Method Development: Used in developing and validating HPLC, UPLC, and LC-MS methods for impurity profiling.
• Quality Control & Assurance (QC/QA): Essential for routine batch release testing in GMP manufacturing environments to monitor impurity levels.
• Regulatory Compliance & Filing: Supports regulatory submissions (e.g., to FDA, EMA) by providing necessary impurity characterization data for drug master files (DMFs).
• Stability Studies: Employed to track the formation of degradation products under various stress conditions (e.g., heat, humidity, light).
• Research & Development: Used in synthetic chemistry R&D to understand and optimize the Clopidogrel manufacturing process to minimize impurity formation.

Basic Information

Product Name	Clopidogrel Impurity 17
CAS No.	1396607-63-8
Molecular Formula	C15H14ClNO2S
Molecular Weight	307.79 g/mol
Synonyms	Clopidogrel Related Compound 17; (S)-Methyl 2-(2-chlorophenyl)-2-((6,7-dihydrothieno[3,2-c]pyridin-5(4H)-yl)amino)acetate; Methyl (2S)-2-[(4,5,6,7-tetrahydrothieno[3,2-c]pyridin-5-yl)amino]-2-(2-chlorophenyl)acetate; Clopidogrel EP Impurity G; Clopidogrel USP Impurity; Clopidogrel Process Impurity; Clopidogrel Intermediate Derivative
EINECS	Contact for details

Quality Control

Every batch of Clopidogrel Impurity 17 is manufactured and analyzed under strict quality management systems. The product undergoes rigorous testing to ensure it meets the high-purity standards required for use as a pharmaceutical reference standard. Comprehensive analytical characterization, including HPLC purity, identity confirmation (IR, MS), and residual solvent analysis, is performed. A Certificate of Analysis (COA) detailing all test results and specifications is provided with each shipment.

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 to prevent degradation. 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)	Total impurities ≤ 2.0% Any individual impurity ≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 0.5% w/w

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