A Science of Impurity
Author: Christopher Hamlin
Publisher: Univ of California Press
Published: 1990-01-01
Total Pages: 364
ISBN-13: 9780520070882
DOWNLOAD EBOOKPosts
Handbook of Isolation and Characterization of Impurities in Pharmaceuticals
Author: Satinder Ahuja
Publisher: Elsevier
Published: 2003-06-26
Total Pages: 432
ISBN-13: 008050776X
DOWNLOAD EBOOKThe United States Food and Drug Administration (FDA) and other regulatory bodies around the world require that impurities in drug substance and drug product levels recommended by the International Conference on Harmonisation (ICH) be isolated and characterized. Identifying process-related impurities and degradation products also helps us to understand the production of impurities and assists in defining degradation mechanisms. When this process is performed at an early stage, there is ample time to address various aspects of drug development to prevent or control the production of impurities and degradation products well before the regulatory filing and thus assure production of a high-quality drug product.This book, therefore, has been designed to meet the need for a reference text on the complex process of isolation and characterization of process-related (synthesis and formulation) impurities and degradation products to meet critical requlatory requirements.It's objective is to provide guidance on isolating and characterizing impurities of pharmaceuticals such as drug candidates, drug substances, and drug products. The book outlines impurity identification processes and will be a key resource document for impurity analysis, isolation/synthesis, and characterization.- Provides valuable information on isolation and characterization of impurities. - Gives a regulatory perspective on the subject. - Describes various considerations involved in meeting regulatory requirements. - Discusses various sources of impurities and degredation products.
Measuring Elemental Impurities in Pharmaceuticals
Author: Robert Thomas
Publisher: CRC Press
Published: 2018-01-29
Total Pages: 474
ISBN-13: 1351984403
DOWNLOAD EBOOKRecent 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.
Pharmaceutical Industry Practices on Genotoxic Impurities
Author: Heewon Lee
Publisher: CRC Press
Published: 2014-08-29
Total Pages: 528
ISBN-13: 1439874212
DOWNLOAD EBOOKA great deal of confusion and uncertainty over genotoxic impurity (GTI) identification, assessment, and control exists in the pharmaceutical industry today. Pharmaceutical Industry Practices on Genotoxic Impurities strives to facilitate scientific and systematic consensus on GTI management by presenting rationales, strategies, methods, interpretati
Impurity and Death
Author: Chikara Abe
Publisher: Universal-Publishers
Published: 2003-09
Total Pages: 112
ISBN-13: 1581121954
DOWNLOAD EBOOKPersonal impurity caused by childbirth, menstrual blood or death is an issue of concern prevalent in many cultures. In Japan, the generic term for these kinds of impurities is kegare and death impurity, a sub-type of kegare, is known as shi-e. The major topic of this book is death impurity. The definition and genesis of shi-e are explained. In addition, details of the influence shi-e had on ancient Japanese society as well as its continuing influence on modern Japanese society are given. Three hypotheses are stated and supported: (1) the shi-e concept began in Japan during the Yayoi period (300 BC - 300 AD) rather than at a later date as previously hypothesized; (2) the basis for the aversion to dead bodies, i.e. shi-e, is that corpses remind people of the fact that they will soon die; (3) Buddhism and Shintoism merged in Japan because of the impact of shi-e on Shintoism. This book concludes with some comments on the relevance of knowledge of the death impurity for students of Japanese history, culture and society.
Metal Impurities in Silicon-Device Fabrication
Author: Klaus Graff
Publisher: Springer Science & Business Media
Published: 2013-03-08
Total Pages: 228
ISBN-13: 3642975933
DOWNLOAD EBOOKA discussion of the different mechanisms responsible for contamination together with a survey of their impact on device performance. The author examines the specific properties of main and rare impurities in silicon, as well as the detection methods and requirements in modern technology. Finally, impurity gettering is studied along with modern techniques to determine gettering efficiency. Throughout all of these subjects, the book presents only reliable and up-to-date data so as to provide a thorough review of recent scientific investigations.
Defects and Impurities in Silicon Materials
Author: Yutaka Yoshida
Publisher: Springer
Published: 2016-03-30
Total Pages: 498
ISBN-13: 4431558004
DOWNLOAD EBOOKThis book emphasizes the importance of the fascinating atomistic insights into the defects and the impurities as well as the dynamic behaviors in silicon materials, which have become more directly accessible over the past 20 years. Such progress has been made possible by newly developed experimental methods, first principle theories, and computer simulation techniques. The book is aimed at young researchers, scientists, and technicians in related industries. The main purposes are to provide readers with 1) the basic physics behind defects in silicon materials, 2) the atomistic modeling as well as the characterization techniques related to defects and impurities in silicon materials, and 3) an overview of the wide range of the research fields involved.
Impurity Scattering in Metallic Alloys
Author: Joginder Singh Galsin
Publisher: Springer
Published: 2012-10-23
Total Pages: 0
ISBN-13: 9781461354574
DOWNLOAD EBOOKSince the introduction of quantum mechanics, the general theory of solid state physics has developed very rapidly. To date, a number of good textbooks on general solid state physics have been written. However, research in solid state physics has become highly specialized and undertaken in narrow fields. There is thus a great need for elementary textbooks that deal in detail with the study of solids in a particular field in order to give students basic knowledge in that field. Metallic solids with an impurity, generally called alloys, are of immense importance from both fundamental and technological points of view. The pioneering work of Bloember gen and Rowland (1953) gave considerable impetus to the study of the electronic structure of metallic alloys. Serious theoretical study in this field started in 1960 and, during the last two decades, considerable success in understanding the electronic structure of simple metal alloys has been achieved. Nonetheless the theoretical study of dilute alloys of transition metals is still in its infancy. At present there are few review articles and original research papers that examine the role of an impurity with respect to the electronic structure and properties of metallic alloys. Because of the absence of an elementary textbook that presents a comprehensive account of different aspects of the electronic structure of metallic alloys, I have written this elementary textbook on the theory of the electronic structure of metallic alloys.
Characterization of Impurities and Degradants Using Mass Spectrometry
Author: Guodong Chen
Publisher: John Wiley & Sons
Published: 2011-04-27
Total Pages: 402
ISBN-13: 0470922974
DOWNLOAD EBOOKThe book highlights the current practices and future trends in structural characterization of impurities and degradants. It begins with an overview of mass spectrometry techniques as related to the analysis of impurities and degradants, followed by studies involving characterization of process related impurities (including potential genotoxic impurities), and excipient related impurities in formulated products. Both general practitioners in pharmaceutical research and specialists in analytical chemistry field will benefit from this book that will detail step-by-step approaches and new strategies to solve challenging problems related to pharmaceutical research.
Handbook of Modern Pharmaceutical Analysis
Author: Satinder Ahuja
Publisher: Academic Press
Published: 2010-11-11
Total Pages: 604
ISBN-13: 0123759811
DOWNLOAD EBOOKHandbook of Modern Pharmaceutical Analysis, Second Edition, synthesizes the complex research and recent changes in the field, while covering the techniques and technology required for today's laboratories. The work integrates strategy, case studies, methodologies, and implications of new regulatory structures, providing complete coverage of quality assurance from the point of discovery to the point of use. - Treats pharmaceutical analysis (PA) as an integral partner to the drug development process rather than as a service to it - Covers method development, validation, selection, testing, modeling, and simulation studies combined with advanced exploration of assays, impurity testing, biomolecules, and chiral separations - Features detailed coverage of QA, ethics, and regulatory guidance (quality by design, good manufacturing practice), as well as high-tech methodologies and technologies from "lab-on-a-chip" to LC-MS, LC-NMR, and LC-NMR-MS
