Popis: |
Anticoagulant and preserving solutions are designed to maintain the viability of blood and blood components. Plastic bags used for human blood storage are classified as Class III product for health. The RDC No. 35 of June 12, 2014 is the legislation that describes the quality control of blood units in Brazil. According to the resolution of the physical and chemical tests to be performed on anticoagulants solutions is the determination of 5-hydroxymethylfurfural content (5-HMF), a highly toxic pollutant formed by thermal decomposition of glucose present in the solutions, which may lead the patient even to death, justifying the need for their control. This work aimed to optimize and validate the methodology for determining the 5-HMF as recommended by ANVISA and the Inmetro. The parameters analyzed in the analytical validation were: specificity, linearity, detection limit, quantification limit, accuracy, precision and robustness. The results showed that the method is very effective for determining the 5-hydroxymethylfurfural which culminated in their integration into technical regulations published in June 2014. |