Endotoxin Testing

Endotoxin testing detects lipopolysaccharide bacterial contamination within pharmaceuticals employing quantitative kinetic chromogenic or turbidimetric Limulus amebocyte lysate assays. These sensitive tests identify bacterial pyrogens at nanogram quantities inadequate for traditional culture-based approaches. Endotoxin specifications establish maximum acceptable levels for parenteral and ophthalmic products protecting patients from pyrogenic reactions. Product-specific method validation confirms assay suitability accounting for potential pharmaceutical interference with test reagents.

Sample preparation requires appropriate dilution and pH conditions optimising assay performance. Positive and negative controls verify reagent integrity and assay performance validity. Results reporting establishes endotoxin units per dose or millilitre ensuring regulatory compliance. Raw material and finished product testing establishes multiple barrier controls preventing endotoxin introduction. Water system validation including purification and storage system assessment ensures pharmaceutical-grade water meets endotoxin specifications. Regulatory inspections evaluate endotoxin testing procedure validity and specification justification.