Description

Clopidogrel Impurity 60 is a high-purity reference standard critical for pharmaceutical research and development. This compound is essential for the identification, qualification, and control of process-related impurities in the synthesis of the widely used antiplatelet drug, Clopidogrel. It is primarily utilized by analytical chemists, quality control laboratories, and regulatory affairs professionals within the pharmaceutical and fine chemical industries to ensure drug safety, efficacy, and compliance with stringent regulatory guidelines.

Application

• Pharmaceutical Reference Standard: Serves as a certified reference material (CRM) for the quantitative and qualitative analysis of Clopidogrel and its related substances.
• Method Development & Validation: Used in developing and validating robust analytical methods, primarily HPLC and LC-MS, for impurity profiling.
• Quality Control & Assurance: Critical for establishing specification limits and monitoring impurity levels during active pharmaceutical ingredient (API) manufacturing to ensure batch-to-batch consistency.
• Regulatory Compliance & Filing: Supports regulatory submissions (e.g., to FDA, EMA) by providing necessary impurity characterization data for drug master files (DMFs) and investigational new drug (IND) applications.
• Stability Studies: Employed as a marker to track the formation of degradation products in Clopidogrel formulations under various stress conditions.
• Research & Development: Used in synthetic route optimization and process chemistry research to understand and minimize the formation of this specific impurity.

Basic Information

Item	Detail
Product Name	Clopidogrel Impurity 60
CAS No.	1430373-12-8
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Clopidogrel Related Compound 60; Clopidogrel Process Impurity 60; (S)-Methyl 2-(2-chlorophenyl)-2-(6,7-dihydrothieno[3,2-c]pyridin-5(4H)-yl)acetate Impurity; 5,6,7,7a-Tetrahydrothieno[3,2-c]pyridin-2(4H)-one derivative (related to Clopidogrel); Clopidogrel EP Impurity I; Potential degradation product of Clopidogrel
EINECS	Contact for details

Quality Control

Every batch of Clopidogrel Impurity 60 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity confirmation, purity assay, and impurity profiling using advanced chromatographic (HPLC, UPLC) 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 for purity, related substances, residual solvents, and other critical quality attributes.

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 must be kept tightly sealed in a dry environment to prevent degradation and ensure long-term stability.

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)	≥ 95.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 5.0% w/w

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