Comparative study on the biological activity of non-fractionated heparin by using sheep plasma coagulation inhibition assay (SPCIA) and activated partial thromboplastin time (APTT) methodologies

Abstract

The aim of this study was to compare the methods of SPCIA and APTT to evaluate the effectiveness of the implementation of APTT as a method for assessing the safety and efficacy of unfractionated heparins in pharmaceuticals. Five lots of non-fractionated heparins (a sulfated polysaccharide used as anticoagulant) from porcine or bovine origin, and from different producers were comparatively evaluated. They were tested based on the 5th International Standard for Heparin, and they were collected by the Brazilian sanitary authorities for evaluating their purity and anticoagulant potency at the National Institute for Quality Control in Health (INCQS). Two methodologies were employed: sheep plasma coagulation inhibition assay (SPCIA) and activated partial thromboplastin time technique (APTT). An excellent correlation between the both methodologies was found, and it showed that technique is easier, faster and objective due to the use of a coagulometer for measuring the clot-forming time, instead of SPCIA assay which uses the subjective visual determination of the coagulation degree. The implementation and execution of APTT technique and the concomitant use of SPCIA assay will improve the technique sensitivity for assessing the non-fractionated heparins safety and efficacy.