Measuring Elemental Impurities in Pharmaceuticals: A Practical Guide

Robert Thomas

jan. 2018 · CRC Press

E-bok

502

Sider

Kvalifisert

Vurderinger og anmeldelser blir ikke kontrollert Finn ut mer

Om denne e-boken

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 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:

The complete guide to measuring elemental impurities in pharmaceutical and nutraceutical materials.
Covers heavy metals testing in the pharmaceutical industry from an historical perspective.
Gives an overview of current USP Chapters and and ICH Q3D Step 4 Guidelines.
Explains the purpose of validation protocols used in Chapter , including how J-values are calculated
Describes fundamental principles and practical capabilities of ICP-MS and ICP-OES.
Offers guidelines about the optimum strategy for risk assessment
Provides tips 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.

Om forfatteren

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

Vurder denne e-boken

Fortell oss hva du mener.

Hvordan lese innhold

Smarttelefoner og nettbrett

Installer Google Play Bøker-appen for Android og iPad/iPhone. Den synkroniseres automatisk med kontoen din og lar deg lese både med og uten nett – uansett hvor du er.

Datamaskiner

Du kan lytte til lydbøker du har kjøpt på Google Play, i nettleseren på datamaskinen din.

Lesebrett og andre enheter

For å lese på lesebrett som Kobo eReader må du laste ned en fil og overføre den til enheten din. Følg den detaljerte veiledningen i brukerstøtten for å overføre filene til støttede lesebrett.

Rapporter ulovlig innhold