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Pyrogen Testing in Parenteral Preparations

Pyrogens are substances produced by microorganisms that cause fever reactions when introduced into the body. Common sources of pyrogens include equipment, solvents, and solutes used in pharmaceutical production. Pyrogens can be eliminated from glass, metal, plastic, and volatile sources through heating or distillation. Nonvolatile pyrogens in solvents and solutes can be removed through adsorption or recrystallization. The biological pyrogen test uses rabbits to detect pyrogens, with a test considered positive if the temperature of individual rabbits increases by more than 0.6°C or the combined increase of three rabbits is over 1.4°C.

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Zhazhe Azhe
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46 views10 pages

Pyrogen Testing in Parenteral Preparations

Pyrogens are substances produced by microorganisms that cause fever reactions when introduced into the body. Common sources of pyrogens include equipment, solvents, and solutes used in pharmaceutical production. Pyrogens can be eliminated from glass, metal, plastic, and volatile sources through heating or distillation. Nonvolatile pyrogens in solvents and solutes can be removed through adsorption or recrystallization. The biological pyrogen test uses rabbits to detect pyrogens, with a test considered positive if the temperature of individual rabbits increases by more than 0.6°C or the combined increase of three rabbits is over 1.4°C.

Uploaded by

Zhazhe Azhe
Copyright
© Attribution Non-Commercial (BY-NC)
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PPS, PDF, TXT or read online on Scribd

For Parentral Preparations

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.

Pyrogen

Sources of progen:
1. Equipment:
Glass Metal Plastic Votatile

2. Solvent:
3. Solute:

Nonvolatile

Pyrogen

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

1. Equipment:

Plastic Wash with detergent

Pyrogen
Elimination of pyrogen:
Votatile

Distilation

2. Solvent:
Nonvolatile

Adsorption

Pyrogen
Elimination of pyrogen:

3. Solute:

Recrystalization

Pyrogen Test
Use Biological Test:

Using group of three rabbits. They should be healthy, mature and of the same weigth and size.

Pyrogen Test
Procedure:
Withheld food in the day of experiment. 2. 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.
1.

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.

With my Best Wishes,,, Manal Abu El-Khair

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