Bepotastine Besilate is a pharmaceutical active ingredient belonging to the second-generation antihistamine class. It is a selective histamine H1-receptor antagonist used in pharmaceutical formulations for the treatment of allergic conditions.
Bepotastine acts by blocking H1 histamine receptors and also inhibits the release of histamine from mast cells. It is used particularly in ophthalmic formulations for the treatment of itching associated with allergic conjunctivitis.
The FDA substance record gives the molecular weight as 547.06 g/mol and describes the salt as a 1:1 combination of bepotastine and benzenesulfonic acid.
Bepotastine Besilate is used in pharmaceutical formulations for:
Bepotastine besilate ophthalmic solution is an established formulation for allergic conjunctivitis.
Bepotastine is a selective H1-receptor antagonist. It reduces the effects of histamine at H1 receptors and also suppresses histamine release from mast cells, contributing to its anti-allergic activity.
| Parameter | Specification |
|---|---|
| Appearance | White to off-white crystalline powder |
| Identification | Conforms — IR identification |
| Assay (HPLC) | 98.0% – 102.0% |
| Loss on Drying | NMT 0.1% |
| Residue on Ignition | NMT 0.1% |
| Individual Impurity | NMT 0.1% |
| Melting Point | Approximately 190°C with decomposition |