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Discuss in detail about any one method of evaluation of pyrogen content in sterile preparation​

Answer»

The Maximum Valid Dilution (MVD) is the maximum allowable dilution of a sample at which the endotoxin limit can be determined.Being sterile means being FREE from microorganisms and being pyrogen-free means being free from fever-causing substances. The difference can be likened to insects and their eggs.The pyrogen TEST on rabbits is based on the measurement of the increase in the rabbit's temperature upon being injected with a PRODUCT that could contain a contaminant of the pyrogen type. The pyrogens, as their name suggests, refer to all the substances that cause an increase in fever, also KNOWN as pyrexia.Testing for pyrogens is a requirement for all parenteral products INCLUDING injectable vaccines, and there have traditionally been two tests for pyrogenicity: the rabbit pyrogen test (RPT) and the Limulus amebocyte lysate (LAL) test.



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