Abstract

DIAZ DE ARMAS, Miriam et al. Validación de técnicas analíticas utilizadas en el control de la calidad. Rev Cubana Farm [online]. 1998, vol.32, n.2, pp.106-112. ISSN 0034-7515.

A methodology was selected and a normative operative procedure was prepared for the validation of analytical methods used in the evaluation of the present productions for quality requirements. The usefulness of this procedure was proved by the validation of the volumetric and spectrophotometric methods taking part in the quality control of the reagent kits for determining haemoglobin in blood. It was demostrated by the experimental design and the statistical procedures used that such methods are lineal (r² 0.98), exact (F_exp < F_tab and T_exp < t_tab), precise (CV £ 3 %) and specific (no significative response). Therefore, they are reliable and may be used in the checking of the quality specifications of the reagent kits.

Keywords : REAGENT KITS, DIAGNOSTIC; HEMOGLOBINS [analysis]; QUALITY CONTROL.

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