Name Betahistine dihydrochloride
Molecular Formula C8H12N2.2HCl
Molecular Weight 209.12
CAS Registry Number 5579-84-0
EINECS 226-966-5
Melting point 150-154 ºC
Appearance A white or almost white crystalline powder
Identification IR should comply with the reference standard
Related substance Impurity A: ≤0.2%Impurity B: ≤0.2%Impurity C: ≤0.2%
Any other impurity: ≤0.1%
Total impurity: ≤0.5%
Solubility Very soluble in water and 96% ethanol; practically insoluble in 2-propanol
Clarity of solution (0.1g in 10ml carbon dioxide free water) Clear
pH 2.0~3.0
Loss on drying ≤1.0%
Residue on ignition ≤0.1%
Sulphate ash ≤0.1%
Assay ≥99.0%