Description

Clopidogrel Impurity 13 is a high-purity reference standard used in the analytical profiling of the antiplatelet drug Clopidogrel. This compound is critical for pharmaceutical research and development, enabling the identification, quantification, and control of specific impurities to ensure drug safety and efficacy. It is an essential material for quality control laboratories, regulatory compliance, and method validation in the pharmaceutical industry.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of Clopidogrel Impurity 13 in active pharmaceutical ingredients (APIs) and finished dosage forms.
• Analytical Method Development and Validation: Used to establish and validate chromatographic methods, such as HPLC and UPLC, for impurity profiling.
• Quality Control and Assurance (QC/QA): Serves as a system suitability standard in routine QC testing to monitor batch-to-batch consistency and ensure compliance with ICH Q3A/B guidelines.
• Regulatory Submissions: Provides essential data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs) to demonstrate impurity control strategies.
• Stability Studies: Employed to track the formation of this specific impurity under various stress conditions (e.g., heat, light, humidity) during drug product stability testing.
• Research and Development: Used in synthetic chemistry research to study the formation pathways and chemical behavior of this impurity.

Basic Information

Product Name	Clopidogrel Impurity 13
CAS No.	2173294-69-2
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Clopidogrel Related Compound 13; Clopidogrel EP Impurity J; Clopidogrel USP Impurity 13; (S)-Methyl 2-(2-chlorophenyl)-2-(6,7-dihydrothieno[3,2-c]pyridin-5(4H)-yl)acetate Impurity; Clopidogrel Process Impurity; 5,6,7,7a-Tetrahydrothieno[3,2-c]pyridin-2(4H)-one derivative (related to Clopidogrel)
EINECS	Contact for details

Quality Control

Our Clopidogrel Impurity 13 is manufactured under strict quality systems and undergoes rigorous analytical testing to ensure it meets the high standards required for pharmaceutical reference materials. Each batch is characterized using advanced techniques including HPLC, GC, MS, and NMR to confirm identity and purity. A comprehensive Certificate of Analysis (COA) is supplied with each shipment, providing batch-specific data. Our quality commitment aligns with cGMP principles and supports compliance with major pharmacopoeial standards (USP, EP, ChP).

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label or Certificate of Analysis. The material should be kept in a dry environment. For long-term storage, consider storing under 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)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0% Any individual unknown impurity ≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 5.0%

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