WHO Proposal to discontinue the test for undue toxicity (chapter 3.7) in the international pharmacopoeia

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