Page 34 - Pharmaceutics IV (02-06-01305)
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Pharmaceutical requirements
Absence of pyrogens
What are pyrogens/endotoxins?
• These substances are bacterial products that may be released from
certain types of bacteria (Gram negative) when they are alive, or after
they die (during sterilization).
• They may therefore be present in sterile products as a by-product of
the sterilization process which kills the bacteria during manufacture.
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Pharmaceutical requirements
Absence of pyrogens
Pyrogenic response:
• Pyrogens, when present in parenteral drug products and injected into
patients, can cause fever, chills, pain in the back and legs, and
malaise. In the seriously ill patient, shock-like symptoms and
hypotension that can be fatal.
• Response depends on the patient condition, count of pyrogens and
the route of administration (most hazardous?)
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Salma E. EL-Habashy
