Description

Clopidogrel is a potent thienopyridine-class antiplatelet agent, widely recognized for its critical role in preventing thrombotic events. Its primary commercial value lies in its use as the active pharmaceutical ingredient (API) in medications that reduce the risk of heart attack and stroke in at-risk patients. This high-purity compound is essential for pharmaceutical manufacturers, research institutions, and contract development and manufacturing organizations (CDMOs) engaged in cardiovascular drug development and production.

Application

• Pharmaceutical API: Primary use as the active ingredient in antiplatelet medications for the prevention of atherothrombotic events.
• Generic Drug Formulation: Key component in the production of generic clopidogrel bisulfate tablets following patent expirations.
• Cardiovascular Research: Critical reagent for in-vitro and in-vivo studies on platelet aggregation, thrombosis, and P2Y12 receptor antagonism.
• Dosage Form Development: Used in R&D for developing novel drug delivery systems, including fixed-dose combinations.
• Reference Standard: Serves as a chemical reference standard in analytical laboratories for quality control and method validation.
• Preclinical Studies: Employed in pharmacological and toxicological testing during the drug development pipeline.

Basic Information

Product Name	Clopidogrel
CAS No.	113665-84-2
Molecular Formula	C16H16ClNO2S
Molecular Weight	321.82 g/mol
Synonyms	Clopidogrel Base; Methyl (2S)-2-(2-Chlorophenyl)-2-(6,7-dihydro-4H-thieno[3,2-c]pyridin-5-yl)acetate; (S)-(+)-Clopidogrel; SR 25989C; PCR 4099; Plavix API; Iscover API; (2S)-2-(2-Chlorophenyl)-2-(4,5,6,7-tetrahydrothieno[3,2-c]pyridin-5-yl)acetic acid methyl ester
EINECS	Contact for details

Quality Control

Our Clopidogrel is manufactured under strict quality management systems, targeting specifications suitable for pharmaceutical applications. Quality is assured through comprehensive analytical testing, including HPLC for assay and impurity profiling, chiral purity determination, and residual solvent analysis. A Certificate of Analysis (COA) is provided with each batch, detailing compliance with agreed specifications. We support audits and can provide documentation relevant to cGMP, ICH Q7, and major pharmacopoeial standards (USP/EP) as required.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). Due to its hygroscopic nature, the container must be kept tightly sealed after opening to minimize exposure to atmospheric moisture. For long-term storage, consider using desiccants.

Specification

Item	Specification
Appearance	White to off-white crystalline powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Assay (HPLC)	98.0% - 102.0% (on anhydrous basis)
Chiral Purity (Enantiomeric Excess)	≥ 99.5%
Related Substances (HPLC)	Individual unknown impurity ≤ 0.10% Total impurities ≤ 0.50%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 0.5% w/w
Residue on Ignition	≤ 0.1%
Heavy Metals	≤ 20 ppm

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