Pharmaceutical elemental impurity analysis (USP<232> and ICHQ3D) following USP<735> X-ray fluorescence spectrometry
Changes to the regulatory requirements for elemental impurity testing with the introduction of USP chapters <232>,<233> and the ICHQ3D guidelines is leading to an industry wide change in the approach to this analysis. In this webinar we introduce the new USP chapters and the ICH guidelines and discuss risk analysis and the need for testing. We will also introduce the new USP chapter <735> X-ray fluorescence spectrometry (XRF) and discuss the development and preliminary results for pharmaceutical calibration standards for elemental impurity testing. Finally, we will take a first look at XRF method validation using a model API.