Traitement du syndrome de Ménière Betahistine HCl

ITEMS

SPECIFICATION

RESULTS

Appearance

White to almost crystalline powder, very hygroscopic

Conforms

Assay

99.0%-101.0%

99.75%

Ph

2~3

2.5

Loss on drying

Not more than 1.0%

0.3%

Sulphated ash

Not more than 0.1%

0.06%

Identification

IR: Similar to the reference standard

HPLC: Similar to the reference standard

Conforms

Residual solvents

(2-propanol)

Not more than 0.5%

0.20%

Solubility

Very soluble in water

Freely soluble in alcohol (96%)

Practically insoluble in 2-propanol

Conforms

Clarity of solution

(0.1g in 10ml carbon dioxide free water)-clear

Conforms

2-(2-Hydroxyethyl)pyridine

Not more than 0.2%

Not detected

2-Vinylpyridine

Not more than 0.2%

0.06%

N-Methyl-N,N-bis(2-Pyridin-2-Yl-ethyl)

amine

Not more than 0.2%

0.13%

Other individual impurity

Not more than 0.1%

Conforms

Total impurities

Not more than 0.5%

0.3%

Conclusion: It conforms to the USP30 STANDARD.