Pyrogen Screening Modal | Pyrogen on Parenteral Product by Rabbit Method | Rabbit Pyrogen हिंदी में

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Pyrogen on Parenteral Product by Rabbit Method | ENGLISH - • Pyrogen Screening Moda...
Pyrogens are the fever-inducing organic substances (metabolic products of microorganisms) responsible for many febrile reactions. Pyrogen testing should be done on every batch of pharmaceutical products (particularly parenteral) for which water is the usual vehicle. The best animal model for pyrogen test is the rabbit as it generates reproducible results that are similar to threshold response to humans and also economic.
Pyrogen testing determines the presence or absence of pyrogens in parenteral pharmaceutical products and is regulated by several standards from organizations such as the Food and Drug Administration (FDA), United States Pharmacopeia (USP), or European Pharmacopeia (EP). The sterility of a product does not imply that it is free of pyrogens. Therefore, drugs that are purported to be sterile must also be tested for pyrogens to prevent febrile reactions in patients.
A pyrogen is a substance that causes a rise in temperature (fever reaction) in a human or animal through the activation of the innate immune system. They constitute a heterogeneous group of contaminants comprising microbial and non-microbial substances. Pyrogens can be classified into two groups: endotoxins and non-endotoxin pyrogens (NEPs). Endotoxins are substances found in Gram-negative bacteria. Non-endotoxin pyrogens are other microbial substances, including those derived from Gram-positive bacteria or viruses and pyrogens originating from yeasts and fungi. Non-microbial pyrogenic substances can also originate from rubber particles, microscopic plastic particles, or metal compounds in elastomers.
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