What is Eptifibatide?
Eptifibatide is a competitive inhibitor of the Gp IIb/IIIa receptor and interferes with the binding of clotting inducing molecules, including fibrinogen, von Willebrand factor (vWF) and prothrombin. Due to its anti-clotting properties, eptifibatide is approved for the treatment of unstable angina and myocardial infarction. It is also approved for patients undergoing coronary interventions such as intracoronary stenting.
Current production of eptifibatide involves solid-phase peptide synthesis followed by reverse-phase liquid chromatography using a gradient of acetonitrile in trifluoroacetic acid. Manufacturing eptifibatide in this way allows for better control of the final product, but there are still impurities that can occur throughout the process. For example, degradants with hydrolyzed peptide bonds resulting in linear products can form during production. There are also four different isomers for eptifibatide, which can be challenging to distinguish without proper methods and reference materials.
USP has developed two new Reference Standards for quality control of eptifibatide production: Eptifibatide and 3-D-Asp Eptifibatide.
Both reference standards can be used to validate system suitability of analytical methods and equipment as well as for quality control of drug substance batches.
In addition, they can be combined with USP’s complete suite of eptifibatide isomer reference standards to comprehensively map the presence of all the major impurities that can occur during the manufacturing process.
What can USP offer you?
The USP Eptifibatide Reference Standards Family: