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.
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A Practical Guide
Produktdetaljer
ISBN
9781351984393
Publisert
2018
Utgave
1. utgave
Utgiver
Vendor
CRC Press
Språk
Product language
Engelsk
Format
Product format
Digital bok
Forfatter