Description

Clopidogrel Bisulfate is the bisulfate salt form of clopidogrel, a potent and selective inhibitor of platelet aggregation. This active pharmaceutical ingredient (API) is the critical component in the production of antiplatelet medications used to prevent thrombotic events. It is essential for pharmaceutical manufacturers developing formulations to treat conditions such as acute coronary syndrome, stroke, and peripheral arterial disease. Our high-purity grade ensures reliable performance and consistency in final drug products.

Application

• Pharmaceutical API: Primary active ingredient in antiplatelet tablets and other dosage forms.
• Cardiovascular Medicine: Manufacture of medications for the prevention of atherothrombotic events in patients with myocardial infarction, ischemic stroke, or established peripheral arterial disease.
• Post-Surgical Care: Used in drug formulations to prevent stent thrombosis and other post-operative clotting complications.
• Generic Drug Production: Sourcing for manufacturers of generic clopidogrel bisulfate tablets following patent expirations.
• Clinical Research: Reference standard or raw material for bioavailability, stability, and formulation studies.
• Veterinary Pharmaceuticals: Potential application in veterinary medicine for antiplatelet therapy in animals.

Basic Information

Product Name	Clopidogrel Bisulfate
CAS No.	120202-66-6
Molecular Formula	C16H16ClNO2S • H2SO4
Molecular Weight	419.90 g/mol
Synonyms	Clopidogrel Hydrogen Sulfate; Clopidogrel Sulphate; (S)-Clopidogrel Bisulfate; Methyl (+)-(S)-α-(2-chlorophenyl)-6,7-dihydrothieno[3,2-c]pyridine-5(4H)-acetate sulfate; SR 25989C; Plavix API; Iscover API
EINECS	Contact for details

Quality Control

Our Clopidogrel Bisulfate is manufactured under strict quality management systems. It is produced to meet exacting standards suitable for pharmaceutical applications, with a focus on high purity and low impurity profiles. Each batch is accompanied by a comprehensive Certificate of Analysis (COA) detailing purity, related substances, residual solvents, and other critical parameters. We ensure compliance with relevant pharmacopeial guidelines and support customer audits and regulatory submissions.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive) and must be kept in a dry environment to prevent degradation. The container should be kept tightly sealed when not in use.

Specification

Item	Specification
Appearance	White or almost white crystalline powder
Identification (IR)	Conforms to reference standard
Identification (HPLC)	Retention time corresponds to reference
Assay (HPLC)	98.0% - 102.0% (on anhydrous basis)
Related Substances (HPLC)	Individual impurity: ≤ 0.15% Total impurities: ≤ 0.5%
Optical Rotation	+51.0° to +55.0° (c=1 in methanol)
Water Content (KF)	≤ 0.5% w/w
Residue on Ignition	≤ 0.1%
Heavy Metals	≤ 20 ppm
Residual Solvents (GC)	Complies with ICH Q3C guidelines

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