Measuring Elemental Impurities in Pharmaceuticals: A Practical Guide Contributor(s): Thomas, Robert (Author) |
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ISBN: 1138197963 ISBN-13: 9781138197961 Publisher: CRC Press OUR PRICE: $171.00 Product Type: Hardcover - Other Formats Published: February 2018 |
Additional Information |
BISAC Categories: - Medical | Pharmacology - Science | Chemistry - Analytic - Technology & Engineering | Food Science - General |
Dewey: 615.1 |
LCCN: 2017038198 |
Series: Practical Spectroscopy |
Physical Information: 474 pages |
Descriptions, Reviews, Etc. |
Publisher Description: 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:
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. |