Description

Clopidogrel Impurity 24 is a designated process-related impurity used in the analytical profiling and quality control of the antiplatelet active pharmaceutical ingredient (API), Clopidogrel. This compound is critical for pharmaceutical manufacturers and analytical laboratories to ensure product purity, safety, and regulatory compliance. It serves as a key reference standard in method development, validation, and stability studies for Clopidogrel production.

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.
• Analytical Method Development: Essential for developing and validating sensitive HPLC, UPLC, or LC-MS methods to monitor impurity profiles.
• Quality Control & Assurance (QC/QA): Used in routine batch release testing to ensure Clopidogrel meets pharmacopeial specifications (e.g., USP, EP, ICH Q3A/B).
• Stability Studies: Employed to track the formation of this specific impurity under various stress conditions (heat, light, humidity) to establish product shelf-life.
• Regulatory Submissions: Provides necessary impurity characterization data for Drug Master Files (DMFs), Common Technical Documents (CTDs), and regulatory filings with agencies like the FDA and EMA.
• Process Chemistry Research: Aids in understanding and optimizing the Clopidogrel synthesis pathway to minimize the formation of this impurity.

Basic Information

Product Name	Clopidogrel Impurity 24
CAS No.	2173294-65-8
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Clopidogrel Related Compound 24; Clopidogrel EP Impurity 24; Clopidogrel USP Impurity 24; (S)-Clopidogrel Impurity 24; Methyl (2S)-2-(2-chlorophenyl)-2-((6,7-dihydrothieno[3,2-c]pyridin-5(4H)-yl)acetate) Impurity; Clopidogrel Process Impurity; Clopidogrel Degradant
EINECS	Contact for details

Quality Control

Every batch of Clopidogrel Impurity 24 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and assay testing using advanced chromatographic and spectroscopic techniques to ensure compliance with industry standards. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results for purity, related substances, and residual solvents.

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 must be kept under dry, inert conditions to maintain stability and purity. For long-term storage, consider desiccation.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 5.0% w/w

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