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Bacterial Endotoxin Testing

Meaning

Bacterial endotoxin testing is a mandatory quality assurance procedure utilized to detect and accurately quantify the presence of lipopolysaccharide (LPS), a potent pyrogenic substance derived from the outer membrane of Gram-negative bacteria. Endotoxins, even in trace amounts, can induce a severe fever response, systemic inflammation, and potentially septic shock if present in injectable pharmaceutical products, including compounded hormone preparations or peptide therapies. This testing is therefore essential for guaranteeing the non-pyrogenicity and safety of all parenteral medications administered in clinical settings.