Reagent Chemicals
Reagent Chemicals

Author: American Chemical Society

Publisher: Acs Professional Reference Boo

Published: 2015

Total Pages: 0

ISBN-13: 9780841230453

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The American Chemical Society (ACS) Committee on Analytical Reagents sets the specifications for most chemicals used in analytical testing. Currently, the ACS is the only organization in the world that sets requirements and develops validated methods for determining the purity of reagent chemicals. These specifications have also become the de facto standards for chemicals used in many high-purity applications. Publications and organizations that set specifications or promulgate analytical testing methods-such as the United States Pharmacopeia and the U.S. Environmental Protection Agency-specify that ACS reagent-grade purity be used in their test procedures. The Eleventh Edition incorporates the "supplements" accumulated over the past eight years, removes some obsolete test methods, improves instructions for many existing ones, and also introduces some new methods. Overall, the safety, accuracy, or ease of use in specifications for about 70 of the 430 listed reagents has been improved, and seven new reagents have been added.

Reagent Chemicals
Reagent Chemicals

Author: American Chemical Society

Publisher: Academic

Published: 2006

Total Pages: 830

ISBN-13: 9780841239456

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Reagent Chemicals, 10 Edition, was published in book form in September 2005, with the specifications official from January 1, 2006. This Web edition duplicates the printed book. It contains exactly the same information as the book, but incorporates electronic features (such as hypertext links) that enhance its usability.

Measuring Elemental Impurities in Pharmaceuticals
Measuring Elemental Impurities in Pharmaceuticals

Author: Robert Thomas

Publisher: CRC Press

Published: 2018-01-29

Total Pages: 457

ISBN-13: 135198439X

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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 , , 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.