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Parenterals: Quality control testing

Pyrogen testing

Rabbit pyrogen test (in vivo)
• It is a qualitative test that involves measuring the rise in temperature

of rabbits within three hours following the intravenous injection of a
test solution.
• Disadvantages: many medical agents can also cause a fever.
• It’s a destructive test (samples of the batch).

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Parenterals: Quality control testing

Pyrogen testing

Bacterial endotoxin test (LAL test)
• It’s a quantitative test that is preferred for the detection of pyrogens

using the limulus amebocyte lysate (LAL), amebocyte lysate from the
blood of the horseshoe crab.
• A test sample is incubated with LAL will form a gel clot or lead to the
development of color.
• It is more sensitive, more rapid, and easier to perform than the rabbit
test.

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Salma E. EL-Habashy 83