A pyrogen is, by definition, a substance that produces a rise in temperature in a human or animal. Pyrogens constitute a heterogeneous group of contaminants comprising microbial and non-microbial substances. The most widely known pyrogen is the endotoxin LPS, which is produced by gram-negative bacterial. Pyrogenic substances in pharmaceutical products can induce life-threatening fever reactions after injection into the human body. Therefore, it is a regulatory requirement to test such products for pyrogens.
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