Clopidogrel Besylate API | Manufacturer & Supplier in India

Swapnroop Pharma · WHO-GMP Certified · +91 87670 62101

Clopidogrel Besylate API

Clopidogrel Besylate is a pharmaceutical active ingredient and the besylate salt form of clopidogrel, a thienopyridine-class antiplatelet agent. It is used as an active pharmaceutical ingredient in formulations intended to reduce platelet aggregation and help prevent thrombotic cardiovascular events.

Clopidogrel Besylate is supplied for pharmaceutical manufacturing and formulation applications. It is a white to off-white crystalline material and is practically insoluble in water. The substance contains one defined stereocenter and corresponds to the S-enantiomer of clopidogrel.

Clopidogrel Besylate API Manufacturing & Supply

Clopidogrel Besylate API is manufactured and supplied under controlled pharmaceutical quality standards. Quality control may include identification, assay, chromatographic purity, related substances, water content, sulfated ash, residual solvents and other applicable quality attributes. Regulatory specifications should be confirmed against the applicable pharmacopoeial standard and current Certificate of Analysis (CoA).

Applications of Clopidogrel Besylate

Clopidogrel Besylate is used as an API in pharmaceutical formulations containing clopidogrel. It is primarily associated with antiplatelet therapy and inhibition of platelet aggregation through P2Y12 ADP receptor antagonism.

Quality & Compliance

The API is evaluated using appropriate analytical procedures to confirm identity, purity, assay and other relevant quality characteristics. Depending on the applicable specification, testing can include IR/HPLC identification, chromatographic purity, specific optical rotation, water, sulfated ash, heavy metals and residual solvents.

Storage & Handling

Store Clopidogrel Besylate in a tightly closed container under the storage conditions specified by the approved product specification. Protect the material from excessive moisture, heat and direct light. Always follow the manufacturer's current specification, SDS and CoA for storage and handling requirements.

Pharmaceutical API Supply

We support pharmaceutical manufacturers, formulation companies, distributors and qualified buyers seeking Clopidogrel Besylate API for pharmaceutical development and manufacturing applications. Product specifications, documentation, packaging and regulatory support can be provided according to applicable requirements.

Detailed Specifications

Parameter Specification
Appearance White to off-white crystalline powder
Identification IR & HPLC compliant
Loss on Drying NMT 0.5%
Residue on Ignition NMT 0.1%
Total Impurities NMT 0.5%
Water Content NMT 1.0%
Melting Point Approximately 184–185°C
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