Milestone offers a practical guide to help chemists determine Elemental Impurities in Pharmaceutical Products and Dietary Supplements.
The Primer provides QA/QC practitioners and Lab Managers insight into the evolution and current status of methods and guidelines for the determination of elemental impurities, whilst educating in the best practices and optimum workflows for the demanding application.
New methods and guidelines are coming from United States Pharmacopeia (USP) Chapters USP <232>, <233> and <2232>, along with counterpart guidelines from International Conference on Harmonization (ICH), which are observed by the European Medicines Agency and referred to as ICH Q3D.
The implementation of the new USP chapters <232> and <233> on elemental impurities, in January 2018, will redefine how the pharmaceutical industry tests for elemental impurities in drug products.
