Recent regulations on heavy metal testing have required the pharmaceutical industry to monitor a suite of elemental impurities in pharmaceutical raw materials, drug products and dietary supplements. These new directives s are described in the new United States Pharmacopeia (USP) Chapters <232>, <233>, and <2232>, together with Q3D, Step 4 guidelines for elemental impurities, drafted by the ICH (International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use), a consortium of global pharmaceutical associations, including the European Pharmacopeia (Ph.Eur.), the Japanese Pharmacopeia (JP) and the USP. This book provides a complete guide to the analytical methodology, instrumental techniques and sample preparation procedures used for measuring elemental impurities in pharmaceutical and nutraceutical materials.
It offers readers the tools to better understand plasma spectrochemistry to optimize detection capability for the full suite of elemental PDE (Permitted Daily Exposure) levels in the various drug delivery categories. Other relevant information covered in the book includes:
- Coverage of heavy metals testing in the pharmaceutical industry from a historical perspective.
- Overview of current status of USP Chapters <232> <233>, <2232> and ICH Q3D Step 4 guidelines.
- An explanation of the strict validation protocols required to meet data quality objectives, including how real-world J-values are calculated.
- Guidelines on the optimum strategy for risk assessment.
- Insight on how best to prepare and present your data for regulatory inspection.
An indispensable resource, the fundamental principles and practical benefits of ICP-OES and ICP-MS are covered in a reader-friendly format that a novice, who is carrying out elemental impurities testing in the pharmaceutical and nutraceutical communities, will find easy to understand.