Description

Clopidogrel Ep Impurity E is a high-purity reference standard critical for analytical and regulatory purposes in the pharmaceutical industry. This compound serves as a key specified impurity for monitoring the quality and stability of the active pharmaceutical ingredient (API) Clopidogrel bisulfate. It is essential for pharmaceutical manufacturers and analytical laboratories engaged in research, development, and quality control processes. Ensuring the accurate identification and quantification of this impurity is fundamental to meeting stringent pharmacopeial standards for drug safety and efficacy.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of impurities in Clopidogrel API and finished dosage forms.
• Method Development and Validation: Critical component in developing and validating analytical methods, particularly HPLC and UPLC, for impurity profiling.
• Stability Studies: Used to monitor the formation of degradation products in Clopidogrel under various stress conditions (e.g., heat, humidity, light).
• Quality Control (QC) Testing: Essential for routine batch release testing in API and finished product manufacturing to ensure compliance with USP, EP, and ICH guidelines.
• Regulatory Submissions: Provides necessary data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs).
• Research and Development: Supports synthetic route optimization and impurity fate and tolerance studies during process development.

Basic Information

Item	Detail
Product Name	Clopidogrel Ep Impurity E
CAS No.	90055-68-8
Molecular Formula	C15H14ClNO2S
Molecular Weight	307.79 g/mol
Synonyms	Clopidogrel Impurity E; (S)-Methyl 2-(2-chlorophenyl)-2-(6,7-dihydrothieno[3,2-c]pyridin-5(4H)-yl)acetate; Clopidogrel Related Compound E; Methyl (2S)-2-(2-Chlorophenyl)-2-[(4S,5R)-6,7-dihydro-4H-thieno[3,2-c]pyridin-5-yl]acetate; Clopidogrel EP Impurity E; Clopidogrel USP Impurity E; Clopidogrel Process Impurity E
EINECS	Contact for details

Quality Control

Every batch of Clopidogrel Ep Impurity E is manufactured and controlled under a strict quality management system. The product undergoes comprehensive analytical testing, including HPLC for purity and identity confirmation (IR, NMR), to ensure it meets the high standards required for pharmaceutical reference materials. A detailed Certificate of Analysis (COA) is provided with each shipment, confirming compliance with relevant specifications. Our quality commitment aligns with ICH Q3A, Q3B, USP, and EP guidelines for impurities in new drug substances and products.

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 should be handled in a dry environment to prevent degradation. For long-term storage, consider desiccated conditions.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to 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.