Betahistine dimesilate

CAS-RN ........................................ 54856-23-4
Documentation ................................. EDMF
Specification ................................. Ph. Eur.

Description ................................... White or almost white powder
Solubility .................................... To pass test
IR Spectrum ................................... Similar to standard
Melting Point ................................. 108-112ºC
Identification TLC ............................ Rf similar to standard
Identification D .............................. To pass test
Colour ........................................ Not more than Ref. B9
Opalescence ................................... Not more than Ref. I
pH ............................................ 2-3
HPLC 2-vinilpyridine .......................... Max 0.2%
HPLC Other impurities ......................... Max 0.10%
HPLC Dibetahistine ............................ Max 0.15%
HPLC Total impurities ......................... Max 0.2%
Chloride (ppm) ................................ Max 35 ppm
Heavy Metals .................................. Max 20 ppm
Sulphates ..................................... Max 250 ppm
Water ......................................... Max 2%
2-Propanol .................................... Max 5000 ppm
Sulphated ash ................................. Max 0.1%
Assay ......................................... 98.0 – 101.0 %