Description

Clopidogrel Impurity 2 (Clopidogrel Iminium Impurity) is a critical process-related impurity and degradation product of the widely used antiplatelet drug, Clopidogrel bisulfate. This compound is essential for pharmaceutical research and development, serving as a key reference standard for method development, validation, and quality control to ensure drug safety and efficacy. It is primarily required by analytical laboratories, quality assurance departments, and regulatory affairs teams within the global pharmaceutical and contract research organization (CRO) sectors.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in Clopidogrel active pharmaceutical ingredient (API) and finished dosage forms.
• Analytical Method Development & Validation: Critical for developing and validating stability-indicating HPLC/UPLC methods in compliance with ICH Q2(R1) and Q3A(R2) guidelines.
• Stability Studies & Forced Degradation: Employed to monitor the formation of degradation products during drug substance and product stability testing under various stress conditions.
• Quality Control & Batch Release: Acts as a system suitability standard and for setting specification limits in the routine QC testing of Clopidogrel batches.
• Regulatory Submissions: Provides necessary impurity characterization data for regulatory filings (e.g., ANDA, NDA, CMC sections) to agencies like the US FDA and EMA.
• Process Chemistry Research: Used by R&D scientists to study and optimize synthetic pathways to minimize the formation of this iminium impurity.

Basic Information

Product Name	Clopidogrel Impurity 2 (Clopidogrel Iminium Impurity)
CAS No.	1396607-49-0
Molecular Formula	C16H16ClNO2S
Molecular Weight	321.82 g/mol
Synonyms	Clopidogrel Iminium Impurity; Clopidogrel Related Compound B; (S)-Methyl 2-(2-chlorophenyl)-2-(6,7-dihydrothieno[3,2-c]pyridin-5(4H)-ylium)acetate; Methyl (2S)-2-(2-chlorophenyl)-2-(6,7-dihydro-4H-thieno[3,2-c]pyridin-5-ylium-5-yl)acetate; Clopidogrel EP Impurity B; Clopidogrel USP Impurity B
EINECS	Contact for details

Quality Control

Every batch of Clopidogrel Impurity 2 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity profile testing using advanced analytical techniques (HPLC, GC, MS, NMR) to ensure compliance with pharmacopeial standards (USP, EP) and ICH guidelines. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment.

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 product is hygroscopic (moisture-sensitive); the container must be kept tightly sealed in a dry environment to prevent degradation.

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)	≥ 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.