Measuring Elemental Impurities in Pharmaceuticals
A Practical Guide
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 , , and , 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…
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Produktdetails
- ISBN: 978-1-351-98439-3
- EAN: 9781351984393
- Produktnummer: 31560012
- Verlag: Taylor & Francis Ltd.
- Sprache: Englisch
- Erscheinungsjahr: 2018
- Seitenangabe: 502 S.
- Plattform: EPUB
- Masse: 23'628 KB
- Abbildungen: 16 schwarz-weiße und 11 farbige Fotos, 182 schwarz-weiße und 75 farbige Zeichnungen, 32 schwarz-weiße Tabellen
Über den Autor
Robert J. Thomas has worked in the field of trace element analysis for over 40 years, including 24 years for an ICP-MS manufacturer and 15 years as a principal of his own consulting company. He has served on the ACS (American Chemical Society) Reagent Chemical Committee for the past 17 years as leader of the elemental impurities task force where he has worked closely with the USP to align heavy metal testing procedures in analytical reagents with those of pharmaceutical materials. He has authored almost 100 publications on trace element analysis and written three textbooks on ICP-MS and related topics, including this new book, which focuses on the new global directives on elemental impurities in pharmaceutical materials and dietary supplements. He is currently editor and frequent contributor to the Atomic Perspectives Column in Spectroscopy Magazine. He has a graduate degree in Analytical Chemistry from the University of Wales in the UK and is a Fellow of the Royal Society of Chemistry (FRSC, and a Chartered Chemist (CChem
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