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30/10/2025, 00:02 Pharmaceutical Solutions & Sterile Dosage Forms
Sources of the pyrogens
Solvents (water) is the main source
Equipment
Packing materials
Raw material used
De-pyrogenation
Depyrogenation is the elimination of all pyrogens from the solvents, equipment, containers and raw
materials.
Achieved either by removal or inactivation:
Ion exchange chromatography (Albumin)
Distillation (water for injection; WFI)
Reverse osmosis (WFI)
Dilution or rinsing (containers)
Adsorption
As they are heat stable and stick to glass ware, depyrogenation is harder than sterilization
To denature the endotoxins, heat for extended period of time: dry heat at 250 for 30 min.
Autoclaving doesn't destroy the pyrogens
Ion exchange and adsorption depend on the negative charge on endotoxin.
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