Description

Clopidogrel is a potent and selective 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 for cardiovascular protection. This compound is essential for pharmaceutical manufacturers developing formulations to treat conditions such as acute coronary syndrome, stroke, and peripheral arterial disease. The material is supplied as a high-purity intermediate or API, meeting stringent pharmacopeial standards for global pharmaceutical production.

Application

• Active Pharmaceutical Ingredient (API): Primary use in the manufacture of antiplatelet medications for cardiovascular diseases.
• Pharmaceutical Intermediates: Serves as a key synthetic intermediate in the production of finished dosage forms like tablets.
• Cardiovascular Drug Formulations: Essential for drugs prescribed for the prevention of atherothrombosis post-myocardial infarction, stroke, or in patients with established peripheral arterial disease.
• Research & Development: Used in preclinical and clinical studies for developing new antiplatelet therapies or combination drugs.
• Generic Drug Manufacturing: A critical component for companies producing generic versions of clopidogrel bisulfate (Plavix®).
• Hospital & Compounding Pharmacy Use: For specialized compounding where specific dosage forms are required.

Basic Information

Product Name	Clopidogrel
CAS No.	1360923-54-1
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 25989; PCR 4099; Plavix API; Clopidogrelum
EINECS	Contact for details

Quality Control

Our Clopidogrel is manufactured under strict quality management systems, targeting compliance with major pharmacopeial standards such as USP, EP, and ICH Q7 guidelines. Every batch undergoes comprehensive analytical testing including identity, purity, and impurity profile analysis. A Certificate of Analysis (COA) detailing specific results for assay, related substances, residual solvents, and other critical parameters is provided with each shipment to ensure full traceability and regulatory compliance for our global B2B clients.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry, and well-ventilated area at a controlled room temperature (15-25°C). Due to its hygroscopic (moisture-sensitive) nature, the container must be kept tightly sealed after opening to prevent degradation from atmospheric moisture. Keep away from incompatible materials.

Specification

Item	Specification
Appearance	White to off-white crystalline powder
Identification (IR)	Conforms to reference standard
Identification (HPLC)	Retention time matches reference
Assay (HPLC)	98.0% - 102.0% (on anhydrous basis)
Related Substances (HPLC)	Individual impurity: NMT 0.5% Total impurities: NMT 1.5%
Optical Rotation	+51.0° to +55.0° (c=1, MeOH)
Water Content (KF)	NMT 0.5%
Residue on Ignition	NMT 0.1%
Heavy Metals	NMT 20 ppm
Residual Solvents (GC)	Complies with ICH Q3C

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