Page 60 - Dosage 1-part2 -ebook_Neat

30/10/2025, 00:02 Pharmaceutical Solutions & Sterile Dosage Forms

1. Direct measurement

2. Microscopical measurement

Tests for samples of the batch… Pyrogen
tests

1. Rabbit pyrogen test

Qualitative test in-vivo testing
Inject the tested solution IV into 3 rabbits and measure the increase in rabbit body temperature.
Pyrogenic solutions would cause elevation in body temperature in 3 hours.

Advantages:

Give reaction similar to that in man.
Detect all types of pyrogens.

Disadvantages:

Expensive & Time consuming
Low sensitivity
Some components of the injection may interfere with the test.

2. Bacterial endotoxin test (LAL test)

LAL (Limulus Amebocyte Lysate) test: LAL is an aqueous extract of blood cells. It reacts with
endotoxin LPS
An in-vitro test.
Depends on gel formation when pyrogens are added.
LAL reagent: The LAL agent contains clotting proteins while pyrogens help coagulation process.

Advantages

Rapid, easier to perform
Inexpensive
Quantitative determination of endotoxins

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