Description

Clopidogrel Impurity 59 is a high-purity reference standard used in the pharmaceutical development and quality control of the antiplatelet drug Clopidogrel. This compound is critical for ensuring the safety and efficacy of the final drug product by enabling the accurate identification, quantification, and control of this specific impurity during manufacturing. It is an essential material for analytical laboratories, quality assurance departments, and research institutions focused on cardiovascular drug development and regulatory compliance.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the qualitative and quantitative analysis of Clopidogrel and related substances.
• Method Development & Validation: Critical for developing and validating robust analytical methods, such as HPLC and LC-MS, for impurity profiling.
• Quality Control (QC) Testing: Used in routine QC testing of Clopidogrel Active Pharmaceutical Ingredient (API) and finished dosage forms to monitor impurity levels against ICH guidelines.
• Stability Studies: Employed to track the formation and growth of this impurity under various stress conditions to determine drug shelf-life.
• Regulatory Submissions: Provides essential data for regulatory filings (e.g., FDA, EMA) to demonstrate comprehensive impurity control strategies.
• Research & Development: Supports synthetic route optimization and degradation pathway studies during the drug development process.

Basic Information

Product Name	Clopidogrel Impurity 59
CAS No.	1122047-98-6
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Clopidogrel Related Compound 59; Clopidogrel EP Impurity J; Clopidogrel USP Impurity; Methyl (2S)-2-(2-chlorophenyl)-2-[(4,5,6,7-tetrahydrothieno[3,2-c]pyridin-5-yl)acetate] Related Substance; (S)-Clopidogrel Impurity 59; Clopidogrel Process Impurity; SR 25989 Impurity
EINECS	Contact for details

Quality Control

Our Clopidogrel Impurity 59 is manufactured under strict quality management systems. Each batch is characterized and qualified using advanced analytical techniques including HPLC, LC-MS, and NMR to ensure high purity and accurate identification. A comprehensive Certificate of Analysis (COA) is supplied with each lot, providing detailed results for identity, purity, and impurity profile. Our quality standards are designed to meet the stringent requirements for pharmaceutical reference materials.

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. Keep the container in a dry, cool, and well-ventilated place. For long-term storage, consider storing under inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Conforms
Identification (MS)	Conforms
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Report and comply with COA
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 2.0%

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