Potency evaluation of unfractionated heparins commercialized in Brazil through anti-factor Xa and anti-factor IIa chromogenic tests and coagulation assay

Abstract

Introduction: Heparin is a drug that has anticoagulant activity, binding to antithrombin and accelerating the rate of inhibition of several proteases involved in the coagulation process. In the 2000s, the world market faced a troubled period regarding heparins after reports of allergic reactions and deaths caused by its use, requiring more rigorous quality control. Objective: The main goal of this work was to perform quality control of unfractionated sodium heparins of porcine origin commercialized in Brazil and heparin raw material on a dry basis, of both porcine and bovine origin, through potency assays. Method: Sixty-four samples of the final product (commercialized) were analyzed: 39 of brand A and 25 of brand B, and six samples of raw materials. Samples were assayed through anti-factor Xa and anti-factor IIa, according to United States Pharmacopeia (USP), and coagulation assay, described in the 5th edition of Brazilian Pharmacopeia (BP). Results: In the present study, 40 heparin samples were approved in all potency assays, while 24 samples were non-approved, 23 of brand A and one of brand B. All samples of porcine-origin raw materials were considered approved, while the three of bovine origin showed lower potency. Conclusions: Almost all non-approved samples presented potency above 110%, which may represent a bleeding risk for patients. Thus, it is necessary to monitor the quality control of heparins and assess the clinical condition of patients undergoing their use to identify and reduce risks and safeguard public health.

Keywords

• Heparin
• Anti-factor Xa Assay
• Anti-factor IIa Assay
• Quality Control
• Human Health