Download or read book A Science of Impurity written by Christopher Hamlin and published by Univ of California Press. This book was released on 1990-01-01 with total page 364 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Handbook of Isolation and Characterization of Impurities in Pharmaceuticals written by Satinder Ahuja and published by Elsevier. This book was released on 2003-06-26 with total page 432 pages. Available in PDF, EPUB and Kindle. Book excerpt: The 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.
Download or read book Chemistry The Impure Science 2nd Edition written by Jonathan Simon and published by World Scientific. This book was released on 2012-06-26 with total page 295 pages. Available in PDF, EPUB and Kindle. Book excerpt: What do you associate with chemistry? Explosions, innovative materials, plastics, pollution? The public's confused and contradictory conception of chemistry as basic science, industrial producer and polluter contributes to what we present in this book as chemistry's image as an impure science. Historically, chemistry has always been viewed as impure both in terms of its academic status and its role in transforming modern society. While exploring the history of this science we argue for a characteristic philosophical approach that distinguishes chemistry from physics. This reflection leads us to a philosophical stance that we characterise as operational realism. In this new expanded edition we delve deeper into the questions of properties and potentials that are so important for this philosophy that is based on the manipulation of matter rather than the construction of theories./a
Download or read book Pharmaceutical Industry Practices on Genotoxic Impurities written by Heewon Lee and published by CRC Press. This book was released on 2014-08-29 with total page 536 pages. Available in PDF, EPUB and Kindle. Book excerpt: A 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
Download or read book Defects and Impurities in Silicon Materials written by Yutaka Yoshida and published by Springer. This book was released on 2016-03-30 with total page 498 pages. Available in PDF, EPUB and Kindle. Book excerpt: This 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.
Download or read book Measuring Elemental Impurities in Pharmaceuticals written by Robert Thomas and published by CRC Press. This book was released on 2018-01-29 with total page 474 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Download or read book Metal Impurities in Silicon Device Fabrication written by Klaus Graff and published by Springer Science & Business Media. This book was released on 2013-03-08 with total page 228 pages. Available in PDF, EPUB and Kindle. Book excerpt: A 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.
Download or read book Impurity Scattering in Metallic Alloys written by Joginder Singh Galsin and published by Springer. This book was released on 2012-10-23 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: Since 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.
Download or read book The Politics of the Impure written by Joke Brouwer and published by V2_ publishing. This book was released on 2010 with total page 358 pages. Available in PDF, EPUB and Kindle. Book excerpt: Summary: It is crucial to understand that our progression through the twentieth century towards our contemporary global Crystal Palace (Peter Sloterdijk) of purity and transparency has been constantly accompanied by an almost physical desire for the pure, not just Mondrian's crystalline structures, but also the addictive taste of white sugar and white bread. This book investigates this urge for the pure, but also advocates a much deeper need for the impure, not to reinstate a new organicism, one more back-to-nature movement, but to trace that progression to a point where all modernist values reverse, where technology becomes an agent for the impure and the imperfect. Technology, long an agent for homogeneity and purity, is now turning into one for heterogeneity and global contingency.
Download or read book Impure Science written by Steven Epstein and published by Univ of California Press. This book was released on 1996 with total page 482 pages. Available in PDF, EPUB and Kindle. Book excerpt: Epstein shows the extent to which AIDS research has been a social and political phenomenon and how the AIDS movement has transformed biomedical research practices through its capacity to garner credibility by novel strategies.
Download or read book Handbook of Modern Pharmaceutical Analysis written by Satinder Ahuja and published by Academic Press. This book was released on 2010-11-11 with total page 604 pages. Available in PDF, EPUB and Kindle. Book excerpt: Handbook 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
Download or read book Identification and Determination of Impurities in Drugs written by S. Görög and published by Elsevier. This book was released on 2000-05-19 with total page 773 pages. Available in PDF, EPUB and Kindle. Book excerpt: Impurity profiling is the common name of a group of analytical activities, the aim of which is the detection, identification/structure elucidation and quantitative determination of organic and inorganic impurities, as well as residual solvents in bulk drugs and pharmaceutical formulations. Since this is the best way to characterise the quality and stability of bulk drugs and pharmaceutical formulations, this is the core activity in modern drug analysis.Due to the very rapid development of the analytical methodologies available for this purpose and the similarly rapid increase of the demands as regards the purity of drugs it is an important task to give a summary of the problems and the various possibilities offered by modern analytical chemistry for their solution. That is the aim of this book.The book is methodology-oriented. In the first chapter some important aspects of the background of impurity-related analytical studies (toxicological, pharmacopoeial aspects, the characterisation of the sources of impurities and the role of impurity profiling in various fields of drug research, production and therapeutic use) are summarised. Chapter two deals with related organic impurities, the strategies for impurity profiling, the use of chromatographic and related separation methods, spectroscopic, and hyphenated techniques. The subject of the third chapter is the identification and determination of residual solvents. The determination of inorganic impurities is discussed in chapter four. The special problems of degradation products as impurities are dealt with in chapter five. A separate chapter has been compiled to deal with one of the most up-to-date problems in contemporary pharmaceutical analysis, the estimation of enantiomeric purity of chiral drugs. Chapter seven is devoted to various approaches to solve the problem of polymorphic modifications as impurities. Since in the broader sense of the word the microbiological purity of drugs and drug products also belongs to this circle, the most important information from this field is summarised in chapter eight. After the mainly methodology-oriented chapters, the final one concentrates on four groups of drugs (peptides, biotechnological products, antibiotics and steroids) in order to demonstrate the use of the methods described earlier.
Download or read book Holy Science written by Banu Subramaniam and published by Feminist Technosciences. This book was released on 2019 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: "Subramaniam examines how science and religion have come together to propel a vision of the modern Indian nation, and in particular, a Hindu nationalist vision of India. Five illustrative cases of bionationalism animate this book: Hindu nationalist narratives of scientific development, colonial law and sexual politics in India, surrogacy and women's roles, the politics of caste and race in the language of genes and genomics, and the alignment of environmental scientists and religious activists. Subramaniam demonstrates that the politics of gender, race, class, caste, sexuality, and indigeneity are deeply implicated in the projects and narratives of the nation. At the same time, she seeks spaces of possibility and new narratives for planetary salvation that defy binary logics, incorporating science and religion, human and nonhuman, and nature and culture"--
Download or read book Scientific Knowledge and Its Social Problems written by Jerome R. Ravetz and published by Routledge. This book was released on 2020-09-10 with total page 417 pages. Available in PDF, EPUB and Kindle. Book excerpt: Science is continually confronted by new and difficult social and ethical problems. Some of these problems have arisen from the transformation of the academic science of the prewar period into the industrialized science of the present. Traditional theories of science are now widely recognized as obsolete. In Scientific Knowledge and Its Social Problems (originally published in 1971), Jerome R. Ravetz analyzes the work of science as the creation and investigation of problems. He demonstrates the role of choice and value judgment, and the inevitability of error, in scientific research. Ravetz's new introductory essay is a masterful statement of how our understanding of science has evolved over the last two decades.
Download or read book H l ne Metzger Historian and Historiographer of the Sciences written by Cristina Chimisso and published by Routledge. This book was released on 2019-12-05 with total page 165 pages. Available in PDF, EPUB and Kindle. Book excerpt: Is there something important to learn from the history of science about knowledge and the mind? Do habits and emotions play a significant role in science? To what extent do present concerns and knowledge distort our understanding of past texts and practices? These are crucial questions in current debates, but they are not new. This monograph evaluates the answers to these and other questions that Hélène Metzger (1889-1944) provided. Metzger, who was the leading historian of chemistry of her generation, left us unparalleled reflections on the theory, practice and aims of history writing. Despite her influence on subsequent generations of thinkers, including Thomas Kuhn, this is the first full-length monograph on her. Beginning with an overview of her life, and the challenges faced by a Jewish woman working within academia, the book goes on to discuss the most important themes of her historiography, and her engagement with other disciplines, notably general history, philosophy, ethnology and religious studies. The book also explores both Metzger’s immediate legacy and the relevance of her ideas for a host of current debates in science studies. The Appendices include four of her historiographical papers, translated into English for the first time.
Download or read book Scientific and Technical Aerospace Reports written by and published by . This book was released on 1991 with total page 308 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book High Performance Computing Systems and Technologies in Scientific Research Automation of Control and Production written by Vladimir Jordan and published by Springer Nature. This book was released on 2021-01-15 with total page 241 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book constitutes selected revised and extended papers from the 10th International Conference on High-Performance Computing Systems and Technologies in Scientific Research, Automation of Control and Production, HPCST 2020, Barnaul, Russia, in May 2020. Due to the COVID-19 pancemic the conference was partly held in virtual mode. The 14 full papers presented in this volume were thoroughly reviewed and selected form 51 submissions. The papers are organized in topical sections on hardware for high-performance computing and its applications; information technologies and computer simulation of physical phenomena.
