Description

Clopidogrel Hydrogen Sulfate is the active pharmaceutical ingredient (API) form of the widely prescribed antiplatelet agent. This compound is critical for the commercial-scale manufacturing of finished dosage forms used to prevent atherothrombotic events. It is primarily required by pharmaceutical companies and contract manufacturing organizations (CMOs) engaged in the production of cardiovascular medications. Consistent quality and reliable supply are paramount for this high-value API.

Application

• Primary Pharmaceutical Ingredient: Core active component in the manufacture of clopidogrel bisulfate tablets (e.g., generic versions of Plavix®).
• Cardiovascular Disease Prevention: Used in formulations to reduce the risk of myocardial infarction (heart attack) and stroke in patients with atherosclerosis.
• Peripheral Artery Disease (PAD) Management: Incorporated into medications for reducing thrombotic complications in patients with PAD.
• Acute Coronary Syndrome (ACS) Treatment: Essential for drugs prescribed following ACS events like unstable angina or non-ST-elevation myocardial infarction (NSTEMI).
• Research & Development: Serves as a reference standard and starting material for novel drug development and analytical method validation.
• Formulation Development: Used in R&D for creating new dosage forms, such as fixed-dose combinations with other cardiovascular agents.

Basic Information

Item	Details
Product Name	Clopidogrel Hydrogen Sulfate
CAS No.	135046-48-9
Molecular Formula	C16H16ClNO2S • H2SO4
Molecular Weight	419.90 g/mol
Synonyms	Clopidogrel Bisulfate; Clopidogrel Hydrogen Sulphate; (+)-(S)-Clopidogrel Bisulfate; (S)-(+)-Clopidogrel Hydrogen Sulfate; SR 25989C; PCR 4099; Methyl (+)-(S)-α-(2-chlorophenyl)-6,7-dihydrothieno[3,2-c]pyridine-5(4H)-acetate sulfate; Plavix API
EINECS	Contact for details

Quality Control

Our Clopidogrel Hydrogen Sulfate is manufactured under strict quality systems. It undergoes comprehensive analytical testing to ensure it meets stringent specifications for identity, purity, and potency, aligning with major pharmacopeial standards. A Certificate of Analysis (COA) documenting results for assay, related substances, residual solvents, and other critical parameters is provided with each batch.

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 maintain stability and prevent degradation.

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: NMT 0.15% Total impurities: NMT 0.5%
Optical Rotation	+51.0° to +56.0° (c=1 in methanol)
Water Content (KF)	NMT 0.5% w/w
Residue on Ignition	NMT 0.1%
Heavy Metals	NMT 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.