Galactosamine limit analysis in total hexosamines in injectable porcine sodium heparin samples

Abstract

Introduction: Research, one of the core areas of health surveillance, has its importance justified by its search for answers to various health problems. Heparin, a biological product with anticoagulant and antithrombotic properties, has been related to adverse events between the years 2007–2008. Because of that, the official compendiums updated the monograph for raw material. However, there is a lack of monographs that evaluate the final product. Objective: The goal of this study is to propose a physicochemical method of analysis of the limits of galactosamine in total hexosamine from the finished product of porcine sodium heparin. Method: We developed an analytical method from the ionexchange high performance liquid chromatography with amperometric detection, with the appropriate evaluations of the system suitability for posterior analysis of three samples of porcine sodium heparin previously submitted to the sample preparation protocol through the Micro Bio-Spin column. Results: The samples were compared to the solution of the system suitability and raw material of porcine sodium heparin. We could detect the presence of galactosamine in one of the three analyzed samples in lower amounts than the limit stipulated by the American pharmacopeia. Conclusions: We concluded that the aforementioned method is efficient for the analysis of the finished product and that is the reason why it will be suggested to the Brazilian pharmacopeia.