Block L.H.,USP Monographs Excipients Expert Committee |
Beckers D.,USP Talc Expert Panel |
Ferret J.,USP Talc Expert Panel |
Meeker G.P.,USP Talc Expert Panel |
And 12 more authors.
Pharmacopeial Forum | Year: 2014
In response to a request from the U.S. Food and Drug Administration through the FDA Monograph Modernization Task Group, the USP Talc monograph is being modernized to ensure that the tests for asbestos have adequate specificity. The USP Excipients Expert Committee of the Council of Experts approved the formation of a Talc Expert Panel, which is charged with modernizing the USP Talc monograph. This Stimuli article outlines the current thinking of the USP Talc Expert Panel and discusses several test procedures and measurement criteria that are under consideration. The Talc Expert Panel is considering these procedures and criteria for recommendation to the USP Excipients Expert Committee for control of Absence of Asbestos in USP Talc. This article concludes with a summary of the adverse health effects resulting from asbestos exposure, and a proposal for updating the Definition and Labeling sections of the USP Talc monograph. The USP Talc Expert Panel's recommendation for revision of the test for Absence of Asbestos will include omission of the infrared spectroscopy test and inclusion of a revised x-ray diffraction procedure, in combination with one or more microscopic evaluations (polarized-light microscopy, transmission electron microscopy, or scanning electron microscopy).