BEATRIZ ELANE DE ALMEIDA
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Resumo IPEN-doc 16159 International collaborative study to establish the 2nd WHO International Standard of Human Recombinant Fillicle Stimulating Hormone for Bioassai2010 - OLIVEIRA, J.E.; ALMEIDA, B.E.; DAMIANI, R.; BARTOLINI, P.; RIBELA, M.T.C.P.The aim of the International Collaborative Study proposed by the National Institute for Biological Standards and Control (WHO) is to calibrate a new preparation of human follicle stimulating hormone (hFSH) relative to the 1st International Standard for bioassay of recombinant-hFSH (WHO 92/642), which is almost exhausted and requires to be replaced. The candidate preparation and four other samples, which correspond to this preparation stored at elevated temperatures (K, L, M, N), were analyzed qualitatively and quantitatively in our laboratory, by reversed-phase high-performance liquid chromatography (RPHPLC). The candidate content determined in six assays (8.59 ± 0.41 μg/ampoule) was 20% lower, when compared with the current standard. Based on this, an average value of 110 IU FSH per ampoule could be assigned to this preparation. The main isoform of the candidate preparation showed a lower retention time (22.5 ± 0.83 min) relative to WHO 92/642 (22.8 ± 0.81 min) and also to an internal reference preparation (22.6 ± 0.86 min). These differences, though, were not significant (p>0.05). Practically identical contents were also determined for K, L, M and N ampoules (8.44 ± 0.20; 8.56 ± 0.33; 8.57 ± 0.38; 8.69 ± 0.30 μg/ampoule, respectively). No significant differences in FSH retention times between the candidate preparation and the ampoules stored at elevated temperatures were observed.Resumo IPEN-doc 16158 Physico-chemical quality control of human chrionic gonadotropin preparations2010 - ALMEIDA, B.E.; OLIVEIRA, J.E.; DAMIANI, R.; DALMORA, S.L.; BARTOLINI, P.; RIBELA, M.T.C.P.Resumo IPEN-doc 16157 Reversed-phase higg-performance liquid chromatography characterization of human menopausal gonadotropin preparations2010 - ALMEIDA, B.E.; OLIVEIRA, J.E.; DAMIANI, R.; SPIGOTI, G.; DALMORA, S.L.; BARTOLINI, P.; RIBELA, M.T.C.P.