Determining Elemental Impurities in pharmaceutical products
4 Oct 2017
New methods and guidelines are coming from USP Chapters <232>, <233> and <2232>, and counterpart guidelines from ICH. Milestone say you should be prepared, as you'll need at least 6 – 12 months for implementation and validation.
These new methods and guidelines are observed by the European Medicines Agency and referred to as ICH Q3D. In January 2018, the implementation of the new USP chapters <232> and <233> on elemental impurities will redefine how the pharmaceutical industry tests for elemental impurities in drug products.
At Milestone, we help chemists offering a practical guidance for determining Elemental Impurities in Pharmaceutical Products and Dietary Supplements.
We created a Primer to provide 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 this demanding application.