Examinando por Autor "Felipe Chávez, Ross Bereniz"

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    Determinación de la calidad de la materia prima celecoxib en seis lotes diferentes mediante los resultados de ensayos fisicoquímicos según USP 39, Lima 2016–2017
    (Universidad Privada Norbert Wiener, 2017-11-25) Felipe Chávez, Ross Bereniz; Lázaro Cartolín, Johana Milagros; Guevara Ortega, Freddy Alberto
    The present research work was conducted with the objective of determining the quality of celecoxib raw material in six different batches through the results of physicochemical tests according to USP 39. The study population consisted of six batches of raw material analyzed in the quality control area of a national pharmaceutical laboratory, during the period from May 2016 to February 2017. The research methodology was carried out in accordance with the specifications of the USP 39 technical standard. The results were: 100% compliant in description, 100% compliant in identification, 100% compliant in solubility, 100% compliant with less than 0.1% in water determination, 100% compliant with less than 0.2% in residue on ignition, 100% compliant with no more than 20 ppm of heavy metals, 100% compliant with no more than 0.5% in organic impurities, and 100% compliant in assay within a range of 98.0% – 102.0%. These results indicated that the celecoxib raw material from different batches, received by a national pharmaceutical laboratory during the period from May 2016 to February 2017, meets the quality standards established by USP 39, regardless of its place of origin.