Name: Measuring Elemental Impurities in Pharmaceuticals: A Practical Guide (en Inglés)
Price: 156540.00 CLP
Availability: InStock
Author: Thomas, Robert
ISBN: 9781138197961

portada Measuring Elemental Impurities in Pharmaceuticals: A Practical Guide (en Inglés)

Formato

Libro Físico

Autor

Robert Thomas

Editorial

CRC Press

Año

2018

Idioma

Inglés

N° páginas

474

Encuadernación

Tapa Dura

ISBN13

9781138197961

N° edición

Categorías

Farmacología
Química analítica
Tecnología alimentaria

Measuring Elemental Impurities in Pharmaceuticals: A Practical Guide (en Inglés)

Robert Thomas (Autor) · CRC Press · Tapa Dura

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Reseña del libro "Measuring Elemental Impurities in Pharmaceuticals: A Practical Guide (en Inglés)"

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.