New elemental impurities guidelines: the road to safer drug products
New guidelines by the U.S. Pharmacopeia (USP) and the International Conference on Harmonization (ICH) will come into force on January 1st, 2018, specifying more stringent permitted daily exposure (PDE) limits for elements of toxicological concern in drug products and drug substances. The same guidelines mandate the use of inductively coupled plasma (ICP) technology for testing pharmaceuticals and their ingredients for elemental impurities. The aim is to take advantage of the method’s superior sensitivity and specificity to obtain accurate and precise results that can be relied upon to facilitate the manufacturing of safe and effective drug products.
Through this in-depth interview with Mike Cole, Director of Analytical Operations at Aptuit, we explore the impact of the new guidelines on the pharmaceutical industry.