QUALITY CONTROL OF API POTENCY, EXCIPIENT BLEND UNIFORMITY, AND HEAVY METALS IMPURITIES BY NON-DESTRUCTIVE AND DIRECT ANALYSIS OF INTACT PILLS BY XRF
Pharmalytical Summit 2021: A Virtual Forum presented by Rigaku is happy to present Glenn Williams, Ph.D. and Thanh Nguyen, Ph.D.
XRF analyses show comparable concentrations to ICP-MS for Class 1 and 2a heavy metals by ICH-Q3D (USP<232>). We will demonstrate quality control of API potency, excipient blend uniformity, heavy metals impurities and the advantages of this non-destructive quality control ready technique for final product testing. In addition, we will discuss the usefulness of XRF in control of manufacturing processes (i.e. blending, tableting, etc.).