Hemolytic potential in vitro assay
This in vitro evaluation assesses the hemolytic potential or toxic hemolysis of the test agent, which could be an active pharmaceutical ingredient or an excipient.
The assay simulates the in vivo process and provides a sensitive and accurate method to evaluate hemoglobin release in the plasma.
The assay should be performed for new injectables and infusions that are in direct contact with the circulating blood.