Abstract

TRIGO ORSINI, Myriam Lina  and  ALEJANDRA SILVIA, Condori Espinoza. Metrological traceability of a secondary standard to a primary cyclosporine standard for biodability tests. Rev.Cs.Farm. y Bioq [online]. 2020, vol.8, n.1, pp.121-132. ISSN 2310-0265.

Abstract Introduction: The metrological traceability process from a secondary standard to a primary one is a property of the result of a measurement or the value of a standard, by which it can be related to established references, usually national or international, through an uninterrupted chain of comparisons, all of which have certain uncertainties. Objective: To carry out the traceability of a secondary standard to a primary one of cyclosporine and in this way to ensure its quality and purity. Methods: The following methods were used: organoleptic description, solubility, identification and quantification by reversed phase High Performance Liquid Chromatography (HPLC). Results: The secondary cyclosporine standard met all the specifications referred to organoleptic description, solubility, identification and a purity of 97.5% was obtained using a primary standard whose titer is 98.5%. Conclusion: The metrological traceability of a secondary standard to a primary standard was carried out in order to be able to use it as a working standard, guaranteeing its title. This property is one of the pillars for the measurement results to be comparable with each other, regardless of the place and time in which they have been carried out, facilitating their universal acceptance and reducing potential technical barriers to trade.

Keywords : Traceability; cyclosporine; primary standard; secondary standard; bioavailability.

        · abstract in Spanish     · text in Spanish     · Spanish ( pdf )