Description

Clopidogrel Impurity 5 is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and efficacy of the antiplatelet drug clopidogrel bisulfate by enabling precise identification and quantification of related substances. It is an essential material for pharmaceutical R&D laboratories, quality control (QC) units, and regulatory affairs departments. The standard supports compliance with stringent pharmacopeial guidelines for impurity profiling and method validation.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of impurities in clopidogrel bisulfate active pharmaceutical ingredient (API) and finished dosage forms.
• Analytical Method Development & Validation: Serves as a critical component in developing and validating HPLC, UPLC, or GC methods for impurity profiling in accordance with ICH Q3A(R2) and Q3B(R2) guidelines.
• Quality Control & Batch Release Testing: Used in routine QC testing to monitor impurity levels and ensure drug substance and product specifications are met for every production batch.
• Stability Studies: Employed to track the formation of degradation products in clopidogrel formulations under various stress conditions (e.g., heat, humidity, light) as part of ICH stability protocols.
• Regulatory Submissions: Provides essential data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs) to demonstrate comprehensive impurity control.
• Research & Process Chemistry: Aids in understanding the synthesis pathway of clopidogrel and optimizing manufacturing processes to minimize the formation of this specific impurity.

Basic Information

Product Name	Clopidogrel Impurity 5
CAS No.	1198213-98-7
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Clopidogrel Related Compound 5; Clopidogrel Bisulfate Impurity 5; (S)-Methyl 2-(2-chlorophenyl)-2-(6,7-dihydrothieno[3,2-c]pyridin-5(4H)-yl)acetate Impurity; Methyl (2S)-2-(2-Chlorophenyl)-2-(4H,5H,6H,7H-thieno[3,2-c]pyridin-5-yl)acetate Impurity; Clopidogrel Process Impurity; Clopidogrel Specified Impurity
EINECS	Contact for details

Quality Control

Our products undergo rigorous quality testing to ensure compliance with industry standards. Each batch of Clopidogrel Impurity 5 is characterized using advanced spectroscopic and chromatographic techniques to confirm identity and purity. We adhere to strict quality management systems, and comprehensive Certificates of Analysis (COA) detailing batch-specific results for identity, assay, purity, and related substances are available upon request. The material is suitable for use under current Good Manufacturing Practice (cGMP) and ICH guidelines.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive) and light-sensitive; therefore, containers must be kept tightly sealed and desiccated to maintain stability and purity. Avoid prolonged exposure to high humidity and temperatures.

Specification

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

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