
A draft
document has been issued to a limited audience following the decision of the
WHO Expert Committee on Biological Standardization (ECBS), it is proposed to
omit chapter 3.7, “Undue Toxicity” in The International Pharmacopoeia and its
reference in the monographs on Kanamycin acid sulfate and Kanamycin
monosulfate.
The test
is sometimes called the abnormal toxicity test.
The principle of the test consists of injecting
the product under investigation into guinea pigs and/or mice. The sample passes the test if no animal shows
any signs of illness, relevant body weight changes or dies within a certain
period. The exact test design and name
varies between the different pharmacopoeias and requirements.
See: https://www.who.int/medicines/areas/quality_safety/quality_assurance/QAS19_822_Undue_Toxicity.pdf?ua=1
Posted by Dr. Tim Sandle,
Pharmaceutical Microbiology
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