1. For Parentral Preparations
Pyrogen Test
For
Parentral Preparations

2. Pyrogen Pyrogen is Products of the growth of microorganisms.
It may be parts of dead cells or metabolic products.
The percence of pyrogen in pharmaceutical product causes:
Febrile reactions ( fever, chills, pain in back and legs and malaise)
Progen are rarely fatal.

3. Pyrogen Sources of progen: 1. Equipment: 2. Solvent: 3. Solute: Glass
Metal
Plastic
Votatile
2. Solvent:
Nonvolatile
3. Solute:

4. Elimination of pyrogen:
1. Equipment:
Glass
Metal
Plastic
Heating to 250oC for 45 min
Heating to 650oC for 1 min
Heating with dil. acid, dil. Alkali or mild oxidizing agent
Wash with detergent

5. Pyrogen Elimination of pyrogen: Distilation 2. Solvent: Adsorption
Votatile
Nonvolatile
Adsorption

6. Pyrogen
Elimination of pyrogen:
3. Solute:
Recrystalization

7. Pyrogen Test Use Biological Test: Using group of three rabbits.
They should be healthy, mature and of the same weigth and size.

8. Pyrogen Test Procedure: Withheld food in the day of experiment.
Record the initial temperature of the rabbits,
any rabbit show temp. more than 39oC should be be excluded.
3. Inject the sample into the ear vein of each rabbit.
4. Measure the temp. after 30 min, 1, 2 & 3 hrs.

9. Pyrogen Test
Results:
The test is +ve when each rabbit show increase in temp. more than 0.6oC or the sum of temp. increase of the three rabbits exceeds 1.4oC.
If only two of the three rabbits show increase in temp., Repeat the test using group of five rabbits, and the test will be +ve if four of the five rabbits show increase in temp. in the repeated test.

10. Thank you
كل عام وأنتم بخير
With my Best Wishes,,,
Manal Abu El-Khair