Page 35 - Pharmaceutics IV (02-06-01305)
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Pharmaceutical requirements
Absence of pyrogens
Source of pyrogens:
• Water is the main source of pyrogens. This is because
Pseudomonas, a gram-negative bacterium, grows readily in water.
• Other sources of endotoxins or pyrogens are raw material,
processing equipment, and human contamination.
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Pharmaceutical requirements
Absence of pyrogens
• Parenteral preparations must be practically free from endotoxins and
pyrogens.
• Removal of pyrogens, once present, from a drug product is
impractical without adversely affecting the drug product.
➢ They are very stable.
➢ They are not destroyed by autoclaving
➢ They are water soluble, will pass through 0.2-μm filters.
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Salma E. EL-Habashy
