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Author: Robert Thomas
Publisher: CRC Press
ISBN: 135198439X
Category : Medical
Languages : en
Pages : 483
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Book 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: 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.
Author: Robert Thomas
Publisher: CRC Press
ISBN: 135198439X
Category : Medical
Languages : en
Pages : 483
Get Book Here
Book 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: 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.
Author:
Publisher:
ISBN:
Category : Alameda County (Calif.)
Languages : en
Pages : 790
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Book Description
Author: Virginia Savage McAlester
Publisher: Knopf
ISBN: 0385353871
Category : Architecture
Languages : en
Pages : 881
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Book Description
The fully expanded, updated, and freshly designed second edition of the most comprehensive and widely acclaimed guide to domestic architecture: in print since its original publication in 1984, and acknowledged everywhere as the unmatched, essential guide to American houses. This revised edition includes a section on neighborhoods; expanded and completely new categories of house styles with photos and descriptions of each; an appendix on "Approaches to Construction in the 20th and 21st Centuries"; an expanded bibliography; and 600 new photographs and line drawings.
Author: Rand McNally and Company
Publisher:
ISBN: 9780528860683
Category : San Mateo County (Calif.)
Languages : en
Pages : 0
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Book Description
Author: Thomas F. King
Publisher: Rowman Altamira
ISBN: 9780759111899
Category : Architecture
Languages : en
Pages : 448
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Book Description
Thomas King brings this important work up to date, taking a new look at cultural resource laws, historic preservation, archaeological fieldwork, the environment, tribal government, and agency management.
Author: Terry Beers
Publisher: Heyday Books
ISBN:
Category : Literary Collections
Languages : en
Pages : 334
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Book Description
Drawing from some of California's best writers and thinkers, this anthology explores the relationship between animal and human in the Golden State.
Author: G. K. Hall and Co. Staff
Publisher: G. K. Hall
ISBN: 9780783896830
Category : Reference
Languages : en
Pages : 388
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Book Description
Author: Anna Lorraine Guthrie
Publisher:
ISBN:
Category : Periodicals
Languages : en
Pages : 1260
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Book Description
Author: Gary S. Morgan
Publisher: New Mexico Museum of Natural History and Science
ISBN:
Category : Science
Languages : en
Pages : 380
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Book Description
Author: Randall T Milliken
Publisher: Routledge
ISBN: 131543251X
Category : Social Science
Languages : en
Pages : 169
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Book Description
Olivella shell beads are ubiquitous at Central California Indian sites and were traded far inland by the local inhabitants. Their distinctive patterns of manufacture provide archaeologists with important chronological, morphological, and distributional information. This guide—authored by a professional artifact replicator and an archaeological expert on shell bead typology-- offers a well developed 16-category typology, including the descriptive, temporal, and metric characteristics of each style, illustrated with almost 200 color photographs. Spiral bound to facilitate field and laboratory work, it is an essential tool for conducting archaeology in the American west. Sponsored by the Society for California Archaeology and Pacific Legacy, Inc.
