Description

Clopidogrel Ep Impurity D is a high-purity reference standard critical for analytical method development and quality control in pharmaceutical manufacturing. This compound is essential for ensuring the safety and efficacy of the antiplatelet drug Clopidogrel by accurately identifying and quantifying this specific process-related impurity. It is primarily required by pharmaceutical R&D laboratories, quality assurance/quality control (QA/QC) departments, and regulatory affairs teams. The material is supplied with comprehensive analytical documentation to support regulatory filings and internal quality standards.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of Clopidogrel Ep Impurity D in active pharmaceutical ingredient (API) and finished drug products.
• Analytical Method Development & Validation: Essential for developing, optimizing, and validating HPLC, UPLC, or LC-MS methods for impurity profiling of Clopidogrel.
• Quality Control & Batch Release: Employed in routine QA/QC testing to monitor impurity levels and ensure batch-to-batch consistency and compliance with ICH Q3A/B guidelines.
• Stability Studies: Used to track the formation of this impurity during forced degradation and long-term stability studies of Clopidogrel formulations.
• Regulatory Submission Support: Provides necessary data and a qualified standard for supporting regulatory filings (e.g., ANDA, NDA) with agencies like the US FDA, EMA, and others.
• Pharmacopoeial Testing: Supports testing against monograph specifications in pharmacopoeias such as USP, EP, or BP where this impurity is controlled.

Basic Information

Product Name	Clopidogrel Ep Impurity D
CAS No.	1421283-60-4
Molecular Formula	C15H14ClNO2S
Molecular Weight	307.79 g/mol
Synonyms	Clopidogrel Epimer D; Clopidogrel Related Compound D; (S)-Methyl 2-(2-chlorophenyl)-2-(6,7-dihydrothieno[3,2-c]pyridin-5(4H)-yl)acetate; Methyl (2S)-2-(2-chlorophenyl)-2-(4,5,6,7-tetrahydrothieno[3,2-c]pyridin-5-yl)acetate; Clopidogrel Impurity D; Clopidogrel EP Impurity D; Clopidogrel Sulfoxide Impurity
EINECS	Contact for details

Quality Control

Every batch of Clopidogrel Ep Impurity D is manufactured under controlled conditions and undergoes rigorous analytical testing to ensure the highest standards of identity, purity, and consistency. Our quality system is designed to meet the stringent requirements of pharmaceutical reference standard applications. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing results for assay, related substances, residual solvents, and other critical parameters, supporting compliance with ICH guidelines and global regulatory expectations.

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); the container must be kept tightly sealed in a dry 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
Assay (HPLC)	≥ 98.0%
Purity (HPLC, Area %)	≥ 99.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 0.10% Total impurities: ≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 0.5%

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