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Books > Science & Mathematics > Biology, life sciences > Life sciences: general issues
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Measuring Elemental Impurities in Pharmaceuticals - A Practical Guide (Paperback)
Loot Price: R1,503
Discovery Miles 15 030
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Measuring Elemental Impurities in Pharmaceuticals - A Practical Guide (Paperback)
Series: Practical Spectroscopy
Expected to ship within 10 - 15 working days
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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 <232>, <233>, and
<2232>, 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
<232> <233> and <2232> and ICH Q3D Step 4
Guidelines. Explains the purpose of validation protocols used in
Chapter <233>, 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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