Measuring Elemental Impurities in Pharmaceuticals

CRC Press

Measuring Elemental Impurities in PharmaceuticalsA Practical Guide\nAuthor(s): Robert Thomas\nFormat: Hardback\nPublisher: Taylor & Francis Ltd, United Kingdom\nImprint: CRC Press\nISBN-13: 9781138197961, 978-1138197961\nSynopsis\nRecent 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 ([url] the Japanese Pharmacopeia (JP) and the USP. This book provides a complete guide to the analytical methodology, instrumental techniqu.