Journal of the Brazilian Chemical Society
Print version ISSN 0103-5053
NOGUEIRA, Raquel et al. Development studies of a new metronidazole certified reference material. J. Braz. Chem. Soc. [online]. 2012, vol.23, n.3, pp.435-444. ISSN 0103-5053. http://dx.doi.org/10.1590/S0103-50532012000300009.
This paper presents the results of the studies carried out with the candidate certified reference material (CRM) of metronidazole, first CRM of this active pharmaceutical ingredient (API) available on the market and second Brazilian CRM of an API. The investigation includes the determination of organic impurities, inorganic impurities and volatiles, validation of the HPLC-DAD method, stability studies under transport and storage conditions, homogeneity testing, calculation of metronidazole content by mass balance, confirmation of the certified value by differential scanning calorimetry (DSC), and estimation of measurement uncertainties.
Keywords : metronidazole; certified reference materials; active pharmaceutical ingredient (API); analytical quality control; high performance liquid chromatography (HPLC).