ESTROGENS, CONJUGATED Estrogeni Coniuncti A
Estrogens, conjugated EUROPEAN PHARMACOPOEIA 8.0 – impurities B, C, D, E, F, G: for each impurity, not more than 0.5 times the area of the principal peak in the chromatogram obtained with reference solution (b) (0.5 per cent); – unspecified impurities:foreachimpurity,notmorethan 0.1 times the area of the principal peak in the chromatogram obtained with reference solution (b) (0.10 per cent); E. estra-1,3,5(10)-triene-3,16α,17α-triol (17-epi-estriol), – sum of impurities other than A: not more than the area of the principal peak in the chromatogram obtained with reference solution (b) (1 per cent); – disregard limit: 0.05 times the area of the principal peak in the chromatogram obtained with reference solution (b) (0.05 per cent). F. estra-1,3,5(10)-triene-3,16β,17β-triol (16-epi-estriol), Loss on drying (2.2.32): maximum 0.5 per cent, determined on 1.000 g by drying in an oven at 105 °C for 3 h. ASSAY Dissolve 25.0 mg in ethanol (96 per cent) R and dilute to 50.0mLwiththesamesolvent.Dilute10.0mLofthis solution to 50.0 mL with ethanol (96 per cent) R.Measurethe absorbance (2.2.25)attheabsorptionmaximumat281nm. G. estra-1,3,5(10)-triene-3,16β,17α-triol (16,17-epi-estriol), Calculate the content of C18H24O3 taking the specific absorbance to be 72.5. IMPURITIES Specified impurities: A, B, C, D, E, F, G. Other detectable impurities (the following substances would, H. 3,16α-dihydroxyestra-1,3,5(10)-trien-17-one, if present at a sufficient level, be detected by one or other of the tests in the monograph.
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