Ibuprofen
This article was originally published in The Tan Sheet
Executive Summary
U.S. Pharmacopeia proposes that a new limits test for 4- isobutylacetophenone be included in the ibuprofen tablets monograph. Research has shown that 4-isobutylacetophenone, a degradation product found in ibuprofen tablets made by several manufacturers, causes adverse reactions such as burning in the mouth and throat in concentrations exceeding .1%. The proposal would limit the level of 4-isobutylacetophenone to .8 mg, or.1%.