| Popis: |
Blood bags are products utilized to collect, store, process, transport, separate and administrate blood or its components. Considering this purposes of use, they may contain solutions in their inside, as anticoagulants and/or preservatives solutions. This products are classified, according with Anvisa RDC no 185 from October 2001, due to their technical complexity as a level III risk product. The technical regulation that guides its registration process is ANVISA´s RDC no 35, from June 2014, in which is normalized the whole quality control process for blood bags in Brazil, including the determination of physical and chemical assays that must be performed on anticoagulant solutions. One of these is the total citrate determination. Citrate solution acts as a buffer, ensuring viability and preserved blood components functions during the storage period. The objective of this study was to develop and validate a methodology to quantify total citrate, different from the one recommended by order no 950, from November 1998. The following parameters were analyzed to validate the methodology under study: specificity, linearity and linear response range, detection limit, quantification limit, accuracy, precision and robustness. The study results showed that the proposed methodology allows a safe, efficient and suitable total citrate determination, to be used in the anticoagulant solutions quality control. This study contributed to insert the methodology in the current legislation, RDC No 35 from June 2014, for the blood bags control. |
