To ensure the quality of your parenteral drug formulations, medical devices, raw materials, excipients, water, water for injection and APIs, our experts offer testing for the detection and control of endotoxins. USP <85> Bacterial Endotoxins Test and USP <161> Transfusion and Infusion Assemblies and Similar Medical Devices specify endotoxin testing requirements, including for medical devices with direct blood or cerebrospinal fluid contact.
Bacterial endotoxins are pyrogens produced in bacteria, which cause fever in humans and other animals. Limulus amebocyte lysate (LAL) is the most common reagent used to detect bacterial endotoxin contamination. The gold standard per USP for testing is the gel clot method.
Testing should be performed on every production lot prior to release. Endotoxin limits are typically established based on formulation, dosage per hour, route of administration and average patient weight, but may also incorporate trending data as well as monograph specifications.
Endotoxin method validation is performed on every product and/or formulation. Validation, or inhibition and enhancement (I/E) testing, ensures that the sample does not interfere with the method, which could lead to false positive or negative data. Validation also ensures proper sensitivity, diluent selection and dilution factor.
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