文拉法辛原料及制剂(缓释胶囊、片、缓释片)(BP2013) Venlafaxine Hydrochloride General Notices (Ph. Eur. monograph 2119) C17H27NO2,HCl 99300-78-4 Action and use Inhibition of 5HT and noradrenaline reuptake; antidepressant. Preparations Prolonged-release Venlafaxine Capsules Prolonged-release Venlafaxine Tablets Venlafaxine Tablets PhEur DEFINITION 1-[(1RS)-2-(Dimethylamino)-1-(4-methoxyphenyl)ethyl]cyclohexanol hydrochloride. Content per cent to per cent (dried substance). CHARACTERS Appearance White or almost white powder. Solubility Freely soluble in water and in methanol, soluble in anhydrous ethanol, slightly soluble or practically insoluble in acetone. It shows polymorphism (). IDENTIFICATION A. Infrared absorption spectrophotometry (). Comparison venlafaxine hydrochloride CRS. If the spectra obtained in the solid state show differences, dissolve the substance to be examined and the reference substance separately in 2-propanol R, evaporate to dryness and record new spectra using the residues. B. It gives reaction (a) of chlorides (). TESTS Acidity or alkalinity Dissolve g in carbon dioxide-free water R and dilute to 10 mL with the same solvent. Add mL of methyl red solution R and mL of M hydrochloric acid. The solution is pink. Not more than mL of M sodium hydroxideis required to change the colour of the indicator to yellow. Related substances Liquid chromatography (). Test solution Dissolve mg of the substance to be examined in the mobile phase and dilute to mL with the mobile phase. Reference solution (a) Dilute mL of the test solution to mL with the mobile phase. Dilute mL of this solution to mL with the mobile phase. Reference solution (b) Dissolve the contents of a vial of venlafaxine for system suitability CRS (containing impurities D and F) in mL of the mobile phase. Column: — size: l = m, ? = mm;
