PYROGEN TEST PYROGEN: A CHEMICAL WHICH AFFECTS THE HYPOTHALAMUS, WHICH REGULATES THE BODY TEMPERATURE. PYROGENICITY Ability to cause a change in body temperature In humans endotoxins cause an increase in temperature which is a fever response. Pyrogenic effect is indirect: the active chemical agent that causes the temperature change is an endogenous pyrogen that is released from blood leucocytes under the influence of endotoxins. This pyrogen affects the hypothalamus of the brain which regulates body temperature. PYROGEN TEST Pyrogen test defines a process used by drug manufactures to determine if bacteria toxins are present in vaccines and drugs that might ...
Introduction 2 The term parenteral is derived from The Greek word Para (outside) Enteron(intestine) It denotes the route of administration other than oral route. o Because this route of administration bypasses the normal body defense mechanisms it is essential that these products are prepared with a higher degree of care and skills than utilized in preparing conventional oral or topical products. o The finished product must be sterile, non- pyrogenic and free from extraneous insoluble materials. Quality Control tests for Parenterals 3 Quality control is a concept which strives to produce a perfect product by a series of measures designed ...
Bacterial Endotoxins • All the pharmacopeia require that Contents radiopharmaceuticals intended for intravenous • Acceptance Criteria administration must be tested to ensure that the • Discussion pyrogen concentration is within acceptable limits. • Example Procedure • Pyrogens most often originate from gram- negative bacterial cell walls – referred to as bacterial endotoxin and that are readily detected by a gel-clot or other techniques based on Limulus amebocyte lysate (LAL). STOP Acceptance Criteria Radiopharmaceutical Production QC Testing Acceptance Criteria: Not More Than 175 EU in the total administered dose. The total administered dose is the maximum Baterial Endotoxin administered volume at ...
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