Keywords
quality control of albumin
quality control of IgG
quality evaluation of hemoderivatives
How to Cite
Abstract
The quality of albumin 20% and immunoglobulin G 5%, produced by Fundação Pró-Sangue Hemocentro de São Paulo was assessed by means of liquid chromatography method, for five years period. Immunoglobulin G 5% and albumin 20% were re-evaluated two and three years, respectively after being produced. Five years after manufacturing date, both products were assessed once again. During five years period-study, the products were stored at temperature ranging from 4o C to 8o C. The quality analysis was performed employing the method recommended by Regulation N. 2,419 of 17/12/1996 of the Brazilian Health Ministry, and by Resolution RDC N. 46, 18/05/2000 of the National Agency for Sanitary Surveillance - Brazilian Health Ministry, and European Pharmacopoeia 1997, 2nd edition. In quality assessments carried out for the last five years, no change was observed in the obtained values when compared to those presented at the time of the products release, with the exception in molecular analysis distribution, which presented a slight increase in dimmers percentage in albumin 20% and in immunoglobulin G 5% solutions. Also, the presence of polymers was detected in immunoglobulin 5% solution after five years storage. In spite of occurring these changes in the analyzed products, the observed values were...
References
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This work is licensed under a Creative Commons Attribution 4.0 International License.
Copyright (c) 2004 Revista do Instituto Adolfo Lutz
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