Ticlopidine Hydrochloride API is the hydrochloride salt of ticlopidine, a thienopyridine antiplatelet agent that inhibits platelet aggregation. Ticlopidine is a prodrug that undergoes metabolic activation and ultimately interferes with ADP-mediated platelet activation and aggregation. PubChem identifies Ticlopidine Hydrochloride with CAS No. 53885-35-1, molecular formula C₁₄H₁₅Cl₂NS, and molecular weight 300.2 g/mol.
Ticlopidine Hydrochloride has been used as an oral antiplatelet drug for prevention of thrombotic events. It is chemically distinct from clopidogrel, although both belong to the thienopyridine class.
Ticlopidine Hydrochloride is also known as Ticlopidine HCl and is the hydrochloride salt of ticlopidine. FDA GSRS identifies the hydrochloride substance with UNII A1L4914FMF.
The API is a crystalline pharmaceutical substance. Its hydrochloride salt has substantially different physicochemical properties from free-base ticlopidine, so the 53885-35-1 hydrochloride form should be used consistently for the product page, CAS information and specifications.
PubChem and FDA GSRS support the CAS number, molecular formula, molecular weight and identity of the hydrochloride substance.
Ticlopidine is converted in the body to active metabolites that interfere with ADP-dependent platelet activation. This reduces platelet aggregation and consequently decreases thrombus formation.
The pharmacological action is associated with inhibition of the platelet ADP receptor pathway and reduced activation of the GPIIb/IIIa fibrinogen-binding mechanism.
Ticlopidine Hydrochloride has historically been used for prevention of thrombotic cardiovascular and cerebrovascular events, including:
Because ticlopidine can cause serious hematologic adverse effects, including neutropenia and thrombotic thrombocytopenic purpura, its clinical use has been substantially replaced by newer antiplatelet agents in many settings.
Ticlopidine Hydrochloride is a synthetic small-molecule API manufactured through controlled chemical synthesis, purification, hydrochloride salt formation and crystallization.
A qualified Ticlopidine Hydrochloride API Manufacturer in India should maintain validated HPLC methods and appropriate controls for assay, related substances, residual solvents, moisture, inorganic residue and the specific impurities identified by the applicable pharmacopoeial standard.
Ticlopidine Hydrochloride is described as a white or almost white crystalline powder. It is sparingly soluble in water and ethanol, very slightly soluble in ethyl acetate and practically insoluble in ether.
Pharmacopoeial/reference information reports a melting point around 189°C for the hydrochloride.
The European pharmacopoeial information available for Ticlopidine Hydrochloride specifies a pH range of 3.5–4.0 for the aqueous test solution, while the Chinese Pharmacopoeia 2025 reports pH 3.0–4.5. For a CMS claiming Ph. Eur. compliance, the 3.5–4.0 range is the more appropriate value.
Ticlopidine Hydrochloride should be protected from light and moisture. Pharmacopoeial information describes storage in tightly closed/light-protective conditions, while the USP monograph specifies preservation in tight containers and storage below 30°C.
A professional Ticlopidine Hydrochloride API supply package may include:
A reliable Ticlopidine Hydrochloride API Manufacturer in India should provide pharmaceutical-grade material supported by validated analytical methods and complete batch documentation. Particular attention should be given to related substances because the USP monograph specifically controls N-methyl ticlopidine, related compounds and other individual impurities.
| Parameter | Specification |
|---|---|
| Appearance | white to off-white crystalline powder |
| Identification | IR & HPLC compliant |
| Assay (HPLC) | 98.0% – 102.0% |
| Loss on Drying | NMT 1.0% |
| Residue on Ignition | NMT 0.1% |
| Heavy Metals | NMT 20 ppm |
| pH (1% Solution) | 3.5–4.0 |
| Individual Impurity | NMT 0.5% |
| Total Impurities | NMT 1.0% |
| Water Content | NMT 1.0% |
| Melting Point | Approx. 189°C reference value |