Betahistine Dihydrochloride

Standard products

CAS-RN 5579-84-0
Documentation CEP/EDMF
Specification Ph. Eur. / USP
Therapeutic use Antivertigo agent:
agonist of histamine 

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%

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