For Parentral Preparations. Pyrogen Pyrogen is Products of the growth of microorganisms. Products of the growth of microorganisms. It may be parts of.

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Presentation transcript:

For Parentral Preparations

Pyrogen Pyrogen is Products of the growth of microorganisms. Products of the growth of microorganisms. It may be parts of dead cells or metabolic products. 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: 2. Solvent: 3. Solute: Glass Metal Plastic Votatile Nonvolatile

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

Pyrogen Elimination of pyrogen: 2. Solvent: Votatile Nonvolatile Distilation 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: 1. Withheld food in the day of experiment. 2. Record the initial temperature of the rabbits, any rabbit show temp. more than 39 o C should be be excluded. any rabbit show temp. more than 39 o C 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.

Pyrogen Test Results: The test is +ve when each rabbit show increase in temp. more than 0.6 o C or the sum of temp. increase of the three rabbits exceeds 1.4 o C. 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.

كل عام وأنتم بخير With my Best Wishes,,, Manal Abu El-Khair