Development studies of a new metronidazole certified reference material

Journal of the Brazilian Chemical Society

Raquel Nogueira¹  Werickson F. C. Rocha¹  Thaís E. Silva¹  Eliane C. P. Rego¹  Gabriela F. Moreira²  Wagner Wollinger¹  Janaína M. Rodrigues¹ 

[1] ,Instituto Nacional de Metrologia, Qualidade e Tecnologia Divisão de Metrologia Química Xerém RJ ,Brazil

关键词: metronidazole;    certified reference materials;    active pharmaceutical ingredient (API);    analytical quality control;    high performance liquid chromatography (HPLC);   

DOI  :  10.1590/S0103-50532012000300009

来源: SciELO

【 摘 要 】

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.

【 授权许可】

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