Clopidogrel Hydrogen Sulphate is a pharmaceutical active pharmaceutical ingredient (API) and a hydrogen sulfate salt of clopidogrel. It is also referred to as Clopidogrel Hydrogen Sulfate, Clopidogrel Bisulfate, Clopidogrel Bisulphate and Clopidogrel Sulphate. The compound is associated with the thienopyridine class of antiplatelet agents.
Clopidogrel Hydrogen Sulphate is used in pharmaceutical formulations as an antiplatelet API. Clopidogrel acts through the platelet ADP/P2Y12 pathway and inhibits ADP-mediated platelet activation and aggregation.
Clopidogrel Hydrogen Sulphate can be supplied as a pharmaceutical-grade API for formulation and manufacturing applications. Quality evaluation may include identification, assay, related substances, loss on drying, residue on ignition, optical rotation, residual solvents and other applicable quality attributes.
The material should be manufactured, tested, packaged and stored according to the applicable approved specification and regulatory requirements.
Clopidogrel Hydrogen Sulphate is used as an API in pharmaceutical formulations containing clopidogrel. It is primarily associated with antiplatelet applications and inhibition of platelet aggregation through the P2Y12 receptor pathway.
Quality testing may include FTIR/HPLC identification, assay, related substances, water or loss on drying, residue on ignition, sulfate identification, residual solvents and other applicable pharmaceutical quality tests.
For commercial supply, the final acceptance criteria should always be based on the current approved specification and batch CoA.
Store Clopidogrel Hydrogen Sulphate in a well-closed container under the storage conditions specified by the applicable manufacturer specification and SDS. Protect the material from excessive moisture, heat and unsuitable light exposure. Follow the current SDS and CoA for handling requirements.
Clopidogrel Hydrogen Sulphate API is available for qualified pharmaceutical manufacturers, formulation companies, distributors and other approved customers. Product specifications, CoA, technical documentation, packaging information and other supporting documents can be provided according to applicable requirements.
| Parameter | Specification |
|---|---|
| Appearance | White to off-white crystalline powder |
| Identification | IR & HPLC compliant |
| Assay (HPLC) | 98.0% – 102.0% |
| Loss on Drying | NMT 0.5% |
| Residue on Ignition | NMT 0.1% |
| Heavy Metals | NMT 20 ppm |
| Melting Point | Approximately 184°C |