氟维司群EP标准.pdfVIP

EUROPEAN PHARMACOPOEIA 8.0 Fulvestrant Mobile phase : water R, methanol R, anhydrous acetic acid R, 01/2012:2443 ethylene chloride R (10:15:25:50 V/V/V/V). Measure the volumes accurately since a slight excess of water produces FULVESTRANT cloudiness. Application : 2 μL; thoroughly dry the points of application. Fulvestrantum Development A : over a path of 15 cm. Drying A : in a current of warm air. Development B : immediately, over a path of 15 cm, after renewing the mobile phase. Drying B : in a current of warm air. Detection : spray with a solution of 0.5 g of thymol R in a mixture of 5 mL of sulfuric acid R and 95 mL of ethanol C H F O S M 607 32 47 5 3 r (96 per cent) R. Heat at 130 °C for 10 min. [129453-61-8] System suitability : reference solution (b): DEFINITION – the chromatogram shows 4 clearly separated spots. 7α-[9-[(RS)-(4,4,5,5,5-Pentafluoropentyl)sulfinyl]nonyl]estra- Results : the principal spot in the chromatogram obtained 1,3,5(10)-triene-3,17β-diol. with the test solution is similar in position, colour and size Content : 97.0 per cent to 102.0 per cent (anhydrous substance). to the principal spot in the chromatogram obtained with reference solution (a). CHARACTERS B. Dissolve 0.1 g in 10 mL of water R. Add 3 mL of Appearance : white or almost white powder.