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FDAs pyrogen and endotoxin guidance (March 2026) discusses the bacterial endotoxins test methods described in USP Chapter (gel clot, photometric, and kinetic methods), USP Chapter for medical devices, and AAMI ST72, recommending that appropriate components and finished products be tested for the presence of pyrogens and endotoxins

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doi: 10.1016/j.redox.2015.07.012

THESE CHEMICALS ARE NOT INTENDED TO BE USED AND SHOULD NOT BE USED IN INAPPROPRIATE APPLICATIONS, SUCH AS, WITHOUT LIMITATION, FOOD ADDITIVES, DRUGS, COSMETICS, HOUSEHOLD CHEMICALS, OR OTHER APPLICATIONS OUTSIDE OF IN-VITRO LABORATORY RESEARCH, PRE-CLINICAL RESEARCH, OR IN LABORATORY CHEMICAL SYNTHESIS OR TESTING OF DIFFERENT MATERIALS