FDA melamine test guidance
This article was originally published in The Tan Sheet
Executive Summary
FDA urges pharmaceutical manufacturers, suppliers and others to test certain ingredients for melamine contamination. In guidance posted Aug. 6, the Center for Drug Evaluation and Research recommends firms use liquid chromatography triple-quadrupole tandem mass spectrometry and gas chromatography/mass spectrometry to test 23 ingredients for the chemical. FDA says in a same-day press release that it "has no reason to believe that the U.S. pharmaceutical supply is contaminated with melamine," but recent melamine contamination problems with pet food and infant formula "underscore the potential problem" (1"The Tan Sheet" Dec. 1, 2008)