Betahistine Dihydrochloride is a histamine analogue and pharmaceutical active ingredient used primarily in the management of Ménière's disease and associated vestibular symptoms, including vertigo. It is classified pharmacopoeially as a histamine H1 receptor antagonist; antihistamine, although its pharmacological activity is more complex than that simple classification suggests.
Betahistine Dihydrochloride is the dihydrochloride salt of betahistine and is supplied as a pharmaceutical-grade API for use in pharmaceutical formulations.
BP/Ph. Eur. describes Betahistine Dihydrochloride as a white or slightly yellow, very hygroscopic powder.
Betahistine is primarily used in formulations for:
| Parameter | Specification |
|---|---|
| Appearance | White to off-white crystalline powder |
| Identification | Conforms — IR / chromatographic identification |
| Assay (HPLC) | 99.0% – 101.0% on dried substance |
| Residue on Ignition | NMT 0.1% |
| pH (1% Solution) | 2.0 – 3.0 |
| Melting Point | 150°C – 154°C |