赖诺普利 EP7.0.pdfVIP

EUROPEAN PHARMACOPOEIA 7.0 Lisinopril dihydrate — total : not more than twice the area of the peak due to DEFINITION liothyronine in the chromatogram obtained with reference (2S)-1-[(2S)-6-Amino-2-[[(1S)-1-carboxy-3-phenylpropyl]- solution (a) (2.0 per cent); amino]hexanoyl]pyrrolidine-2-carboxylic acid dihydrate. — disregard limit : 0.5 times the area of the peak due to Content : 98.5 per cent to 101.5 per cent (anhydrous substance). liothyronine in the chromatogram obtained with reference solution (b) (0.05 per cent). CHARACTERS Chlorides : maximum 2.0 per cent, expressed as NaCl (dried Appearance : white or almost white, crystalline powder. substance). Solubility : soluble in water, sparingly soluble in methanol, Dissolve 0.500 g in a 2 g/L solution of sodium hydroxide R and practically insoluble in acetone and in anhydrous ethanol. dilute to 100 mL with the same solvent. Add 15 mL of dilute nitric acid R and titrate with 0.05 M silver nitrate, determining IDENTIFICATION the end-point potentiometrically (2.2.20). Infrared absorption spectrophotometry (2.2.24). 1 mL of 0.05 M silver nitrate is equivalent to 2.93 mg of NaCl. Comparison : lisinopril dihydrate CRS. Loss on drying (2.2.32): maximum 4.0 per cent, determined on 0.500 g by drying in vacuo at 60 °C. TESTS ASSAY Specific optical rotation (2.2.7): −43 to −47 (anhydrous Liquid chromatography (2.2