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Three new and five known steroidal compounds as impurities in nomegestrol acetate(I) were isolated from the enriched mother liquor via various chromatographic methods. Their structures were elucidated by spectrometric analysis and single-crystal X-ray diffraction analysis. New compounds were characterized as 17α-hydroxyl-3-oxoes-trane-5β,17-dicarbonitrile(1), 4-ethyl-17α-hydroxyl-3-oxoestr-4-en-17-carbonitrile(2), 4-ethylestr-4-en-3,17-dione(3). The 13C NMR data of known estrane derivatives(4―7) were also reported first time in this paper. The study may be helpful to identifing and characterizing all the impurities that are present at a level of 0.1% and be useful in the quality control of the production of nomegestrol acetate.
Three new and five known steroidal compounds as impurities in nomegestrol acetate (I) were isolated from the enriched mother liquor via various chromatographic methods. Their structures were elucidated by spectrometric analysis and single-crystal X-ray diffraction analysis. -hydroxyl-3-oxoes-trane-5β, 17-dicarbonitrile (1), 4-ethyl-17α-hydroxyl-3-oxoestr-4-en- The 13C NMR data of known estrane derivatives (4-7) were also reported first time in this paper. The study may be helpful to identify and characterizing all the impurities that are present at a level of 0.1 % and be useful in the quality control of the production of nomegestrol acetate.