Betahistine dihydrochloride

CAS-RN ........................................ 5579-84-0
Documentation ................................. CEP/EDMF
Specification ................................. Ph. Eur. / USP

Description ................................... White solid
IR Spectrum ................................... Similar to standard
Identification Chloride ....................... To pass test
Melting Point ................................. 150 – 154ºC
Appearance of solution ........................ Total and clear
Colour ........................................ Not more than Ref. B8
Opalescence ................................... Not more than Ref. I
pH ............................................ 2 - 3
HPLC Impurity A (2-vinylpiridine) ............. Max 0.1%
HPLC Impurity B ............................... Max 0.2%
HPLC Impurity C ............................... Max 0.2%
HPLC Unknown impurities ....................... Max 0.10%
HPLC Total impurities ......................... Max 0.5%
Loss on drying ................................ Max 1%
Sulphated Ash ................................. Max 0.1%
Heavy metals .................................. Max 20ppm
Residual ethanol .............................. Max.: 1000ppm
Assay ......................................... 99.0 – 101.0%