Clopidogrel Hydrogen Sulfate is the hydrogen sulfate salt of clopidogrel and is widely known as Clopidogrel Bisulfate or Clopidogrel Bisulphate. It is a thienopyridine-class antiplatelet active pharmaceutical ingredient (API) used in pharmaceutical formulations designed to inhibit ADP-mediated platelet activation and aggregation.
Clopidogrel Hydrogen Sulfate is supplied as a pharmaceutical-grade API for formulation and manufacturing applications. It is characterized by its defined stereochemistry and is generally described as a white to off-white crystalline material. The substance has the molecular formula C₁₆H₁₈ClNO₆S₂ and a molecular weight of approximately 419.90 g/mol.
Clopidogrel Hydrogen Sulfate API is manufactured through controlled pharmaceutical processes with appropriate analytical controls. Quality evaluation may include appearance, identification by FTIR/HPLC, assay, organic impurities, water content, sulfated ash, residual solvents and other applicable quality attributes. Regulatory assessments have described specifications covering these quality parameters as well as physical characteristics such as polymorphic form and particle-size properties.
Clopidogrel Hydrogen Sulfate is used as an API in pharmaceutical formulations containing clopidogrel. Clopidogrel acts as an antiplatelet agent by inhibiting ADP-mediated platelet activation and aggregation through the platelet P2Y12 receptor pathway.
Quality testing for Clopidogrel Hydrogen Sulfate can include identification, assay, related substances, loss on drying, residue on ignition or sulfated ash, residual solvents and other applicable pharmaceutical quality tests. USP identifies Clopidogrel Bisulfate with an assay range of 97.0%–101.5% on the dried basis in its monograph.
Store Clopidogrel Hydrogen Sulfate in well-closed containers under the storage conditions specified in the applicable product specification. Protect the material from excessive moisture, heat and direct light. The applicable pharmacopoeial information specifies protection from light. Always refer to the current manufacturer's CoA, specification and SDS for handling and storage requirements.
Clopidogrel Hydrogen Sulfate API can be supplied for pharmaceutical formulation, research and manufacturing applications, subject to applicable quality, regulatory and commercial requirements. Product documentation such as specifications, CoA and supporting technical documents can be provided according to customer and regulatory requirements.
| Parameter | Specification |
|---|---|
| Appearance | White to off-white crystalline powder |
| Identification | IR & HPLC compliant |
| Assay (HPLC) | 97.0% – 101.5% on dried basis |
| Loss on Drying | NMT 0.5% |
| Residue on Ignition | NMT 0.1% |
| Total Impurities | ≤ 1.5% |
| Water Content | NMT 0.5% |
| Melting Point | Approximately 184–185°C |