Clopidogrel Bisulfate

Synonyms: Clopidogrel hydrogen sulfate, Plavix, Iscover, SR-25990C, Clopidogrel bisulphate

Clopidogrel bisulfate is the hydrogen sulfate salt of clopidogrel, a thienopyridine-class antiplatelet agent used to prevent thrombotic events in patients with cardiovascular disease. It was developed by Sanofi and Bristol-Myers Squibb and first approved in 1997 under the brand name Plavix. As an API, it is a white to off-white crystalline powder that is slightly soluble in water and freely soluble in methanol. The bisulfate salt form was chosen for its improved stability and aqueous solubility compared to the free base.

Chemically, clopidogrel bisulfate is a prodrug that requires hepatic metabolism to generate its active metabolite. The parent molecule contains a thienopyridine core with a chiral center at the benzylic position; only the S-enantiomer is pharmacologically active. The bisulfate salt is the (S)-(+)-enantiomer, and the presence of the sulfuric acid moiety contributes to its crystallinity and handling properties. It is typically supplied as a white powder with a characteristic crystalline structure, and its purity is critical for ensuring consistent therapeutic performance.

In the pharmaceutical industry, clopidogrel bisulfate is classified as a high-potency API and is primarily used in the manufacture of oral tablets. It is often combined with aspirin in fixed-dose combinations for dual antiplatelet therapy. The API is subject to stringent quality control, including enantiomeric purity and residual solvent testing, to meet pharmacopeial standards such as USP and EP. Its market demand remains strong due to the widespread use of clopidogrel in secondary prevention of atherothrombotic events.

Function & Mechanism

• Irreversible P2Y12 inhibition: The active metabolite forms a disulfide bond with the P2Y12 receptor on platelets, blocking ADP-mediated activation.
• Prodrug activation: Requires hepatic cytochrome P450 enzymes (CYP2C19, CYP3A4) to convert to the active thiol metabolite.
• Antiplatelet effect: Inhibits platelet aggregation and reduces the risk of thrombus formation.
• Dual antiplatelet therapy: Frequently co-administered with aspirin for synergistic platelet inhibition.
• Secondary prevention: Used in patients with recent myocardial infarction, stroke, or peripheral arterial disease.

Source & Standardization

• Source: Synthetic chemical synthesis
• Standardization: Complying with USP/EP/BP monographs; assay 98.0%–102.0% (HPLC)
• Forms: White to off-white crystalline powder
• Applications: Oral tablets, fixed-dose combinations, research
• Storage: Store in tight containers, protected from light and moisture

Quality Specifications (QC Tests)

Bulk Supply & Documentation

• Monthly capacity: 500 kg
• Lead time: 3-5 business days (stock items)
• Documentation: COA, MSDS, TDS available upon request
• Packaging: 25 kg fiber drum with double polyethylene liners

Frequently Asked Questions

What is the minimum order quantity (MOQ)?

Our standard MOQ is 1 kg. For larger quantities, we can offer competitive pricing.

Do you provide samples for testing?

Yes, we can provide samples for quality evaluation. Please contact us for details.

What is the typical lead time for orders?

Lead time is typically 3-5 business days after order confirmation, depending on quantity and destination.

Contact & Ordering Information

• Company: LyvBio Co., Ltd.
• Address: Room 5-0203, Courtyard 205, Lianhu District, Xi’an, Shaanxi, China
• Email: info@lyvbio.com
• Phone: +86-29-65816888

Learn more about our quality control and certifications, or send us your specification for a quotation.