Download or read book Extractables and Leachables written by Dennis Jenke and published by John Wiley & Sons. This book was released on 2022-08-02 with total page 468 pages. Available in PDF, EPUB and Kindle. Book excerpt: EXTRACTABLES AND LEACHABLES Learn to address the safety aspects of packaged drug products and medical devices Pharmaceutical drug products and medical devices are expected to be effective and safe to use. This includes minimizing patient, user or product exposure to impurities leached from these items when the drug product is administered or when the medical device is used. Clearly, patient or user exposure to leachables must not adversely impact their health and safety. Furthermore, these impurities must not adversely affect key quality attributes of the drug product or medical device, including its manufacturability, stability, efficacy, appearance, shelf-life and conformance to standards. Extractables and leachables are derived from the drug product’s packaging, manufacturing systems and/or delivery systems or from the medical device’s materials of construction. It is imperative to understand and quantify the release of extractables from these items, the accumulation of leachables in drug products and the release of leachables from medical devices. Once extractables and leachables have been discovered, identified and quantified, their effect on the key product or device quality attributes, including safety, must be systematically and scientifically established according to recognized, rigorous and relevant regulatory and compendial standards and industry-driven best practices. In Extractables and Leachables, the chemical compatibility (including safe use) of drugs (and their containers, delivery devices and manufacturing systems) and medical devices is examined at length, focusing particularly on how trace-level extractables and leachables affect the quality and safety of a medical product and how to assess the magnitude of the effect. This is accomplished by addressing the two critical activities required to develop, register and commercialize safe, effective and affordable clinical therapies; measuring extractables and leachables (chemical characterization) and assessing their impact (for example, toxicological safety risk assessment). Each of these activities is addressed in-depth, based on the existing and developing international regulations and guidelines, current published literature and the author’s extensive personal experience. Written by a key contributor to standards, guidelines, recommended practices and the scientific literature, the book provides “insider” insights beyond those gained by merely reading the relevant texts. Given that the rapidly evolving extractables and leachables landscape, this book provides the most current and crucial information on new and forthcoming regulations and best practices. Extractables and Leachables readers will also find: A thorough summary of regulatory and compendial guidelines and the steps required to meet them A detailed and in-depth review of essential scientific principles and recommended best practices for the design, implementation, interpretation and reporting of chemical characterization studies A practical resource for optimizing the development, registration, and commercialization of safe and effective medical products A helpful tool to maximize product development and successful regulatory outcomes Extractables and Leachables is the essential reference for pharmaceutical scientists, analytical chemists, regulatory affairs professionals, engineers, and toxicologists in areas such as product research and development, product registration and approval, regulatory affairs, analytical science, quality control, and manufacturing.

Download or read book Chemistry and Technology of Surfactants written by Richard J. Farn and published by John Wiley & Sons. This book was released on 2008-04-15 with total page 336 pages. Available in PDF, EPUB and Kindle. Book excerpt: Surfactants are used throughout industry as components in a hugerange of formulated products or as effect chemicals in theproduction or processing of other materials. A detailedunderstanding of the basis of their activity is required by allthose who use surfactants, yet the new graduate or postgraduatechemist or chemical engineer will generally have little or noexperience of how and why surfactants work. Chemistry & Technology of Surfactants is aimed at newgraduate or postgraduate level chemists and chemical engineers atthe beginning their industrial careers and those in later life whobecome involved with surfactants for the first time. The book is astraightforward and practical survey of the chemistry ofsurfactants and their uses, providing a basic introduction tosurfactant theory, information on the various types of surfactantand some application details. This will allow readers to build ontotheir scientific education the concepts and principles on which thesuccessful use of surfactants, across a wide range of industries,is based.

Download or read book Liquid Chromatography Time of Flight Mass Spectrometry written by Imma Ferrer and published by John Wiley & Sons. This book was released on 2009-05-06 with total page 281 pages. Available in PDF, EPUB and Kindle. Book excerpt: Time of flight mass spectrometry identifies the elements of a compound by subjecting a sample of ions to a strong electrical field. Illuminating emerging analytical techniques in high-resolution mass spectrometry, Liquid Chromatography Time-of-Flight Mass Spectrometry shows readers how to analyze unknown and emerging contaminants—such as antibiotics, steroids, analgesics—using advanced mass spectrometry techniques. The text combines theoretical discussion with concrete examples, making it suitable for analytical chemists, environmental chemists, organic chemists, medicinal chemists, university research chemists, and graduate and post-doctorate students.

Download or read book Advances in Potato Chemistry and Technology written by Jaspreet Singh and published by Academic Press. This book was released on 2009-07-22 with total page 523 pages. Available in PDF, EPUB and Kindle. Book excerpt: Developments in potato chemistry, including identification and use of the functional components of potatoes, genetic improvements and modifications that increase their suitability for food and non-food applications, the use of starch chemistry in non-food industry and methods of sensory and objective measurement have led to new and important uses for this crop. Advances in Potato Chemistry and Technology presents the most current information available in one convenient resource.The expert coverage includes details on findings related to potato composition, new methods of quality determination of potato tubers, genetic and agronomic improvements, use of specific potato cultivars and their starches, flours for specific food and non-food applications, and quality measurement methods for potato products. - Covers potato chemistry in detail, providing key understanding of the role of chemical compositions on emerging uses for specific food and non-food applications - Presents coverage of developing areas, related to potato production and processing including genetic modification of potatoes, laboratory and industry scale sophistication, and modern quality measurement techniques to help producers identify appropriate varieties based on anticipated use - Explores novel application uses of potatoes and potato by-products to help producers identify potential areas for development of potato variety and structure

Download or read book Microbiology of Fruits and Vegetables written by Gerald M. Sapers and published by CRC Press. This book was released on 2005-08-29 with total page 660 pages. Available in PDF, EPUB and Kindle. Book excerpt: Microbiology of Fruits and Vegetables presents a holistic view of the problem of produce contamination that examines both pre-harvest and post-harvest sources and practices. It addresses a number of topical issues relating to the microbiological quality and safety of fresh and processed fruits and vegetables and explores the linkage between microbial attachment, the state of microbial contaminants on produce surfaces, and the problem of decontamination. This volume focuses on five distinct areas, and within these areas, provides in-depth coverage of scientific issues important to an understanding of the field and technical issues of economic and public health significance.

Download or read book Tropical Glaciers written by Georg Kaser and published by Cambridge University Press. This book was released on 2002 with total page 232 pages. Available in PDF, EPUB and Kindle. Book excerpt: Glaciers in the tropics and their environmental consequences.

Download or read book Applications in High Resolution Mass Spectrometry written by Roberto Romero-González and published by Elsevier. This book was released on 2017-03-07 with total page 362 pages. Available in PDF, EPUB and Kindle. Book excerpt: Applications of High Resolution Mass Spectrometry: Food Safety and Pesticide Residue Analysis is the first book to offer complete coverage of all aspects of high resolution mass spectrometry (HRMS) used for the analysis of pesticide residue in food. Aimed at researchers and graduate students in food safety, toxicology, and analytical chemistry, the book equips readers with foundational knowledge of HRMS, including established and state-of-the-art principles and analysis strategies. Additionally, it provides a roadmap for implementation, including discussions of the latest instrumentation and software available. Detailed coverage is given to the application of HRMS coupled to ultra high-performance liquid chromatography (UHPLC-HRMS) in the analysis of pesticide residue in fruits and vegetables and food from animal origin. The book also discusses extraction procedures and the challenges of sample preparation, gas chromatography coupled to high resolution mass spectrometry, flow injection-HRMS, ambient ionization, and identification of pesticide transformation products in food. Responding to the fast development and application of these new procedures, this book is an essential resource in the food safety field. - Arms researchers with an in-depth resource devoted to the rapid advances in HRMS tools and strategies for pesticide residue analysis in food - Provides a complete overview of analytical methodologies and applications of HRMS, including UHPLC-HRMS, HRMS coupled with time of flight (TOF) and/or GC-Orbitrap, and flow injection-HRMS - Discusses the current international regulations and legislation related to the use of HRMS in pesticide residue analysis - Features a chapter on the hardware and software available for HRMS implementation - Offers separate chapters on HRMS applied to pesticide residue analysis in fruits and vegetables and in food from animal origin

Download or read book Food Packaging Science and Technology written by Dong Sun Lee and published by CRC Press. This book was released on 2008-04-01 with total page 644 pages. Available in PDF, EPUB and Kindle. Book excerpt: With a wealth of illustrations, examples, discussion questions, and case studies, the Food Packaging Science and Technology covers basic principles and technologies as well as advanced topics such as active, intelligent, and sustainable packaging with unparalleled depth and breadth of scope. Emphasizing the application of relevant scientific

Download or read book Natural and Cultural History of Beargrass Xerophyllum Tenax written by Susan Hummel and published by CreateSpace. This book was released on 2015-02-14 with total page 86 pages. Available in PDF, EPUB and Kindle. Book excerpt: Beargrass is a source of food, habitat, and raw material for animals, pollinating insects and people across its range in the Western United States. The plant has long been used by Native Americans, who harvest the leaves for basketry and other crafts. More recently, beargrass has become an important component of international trade for the commercial floral greens industry.

Download or read book Progress in Experimental Tumor Research written by F. Homburger (ed) and published by . This book was released on 1960 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt:

Download or read book Census Information Center Program written by United States. Bureau of the Census and published by . This book was released on 2001 with total page 4 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Download or read book An R Companion to Applied Regression written by John Fox and published by SAGE Publications. This book was released on 2011 with total page 473 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book aims to provide a broad introduction to the R statistical environment in the context of applied regression analysis, which is typically studied by social scientists and others in a second course in applied statistics.

Download or read book Beverage Impacts on Health and Nutrition written by Ted Wilson and published by Humana Press. This book was released on 2016-02-24 with total page 378 pages. Available in PDF, EPUB and Kindle. Book excerpt: This comprehensive and authoritative second edition offers food scientists, nutritionists, public health specialists, and those involved in the research and development of new beverages an exhaustive survey of how common beverages impact our health and nutrition, as well as a basis for research designed to produce healthier beverages.​ Every year brings an improvement in our understanding of how the many types and aspects of what we drink (beverages) impact our health and a desire to understand the current state of affairs for beverage technology. There is still no new single book that provides objective reviews on the wide range of global health issues associated with alcoholic ad non-alcoholic beverages. Beverage Impacts on Nutrition and Health, Second Edition is the single best source of reviews that describe beverage history; coffee, tea, alcohol, wine, cranberry and citrus juice, tea, coffee, dairy milk, soy milks and breast milk. Furthermore the book contains up-to-date reviews that describe beverage effects on satiety and energy balance, recommendations for persons with diabetes and metabolic syndrome, nutritional supplementation for the elderly, performance enhancement by athletes, energy drinks, and bottled water qualities. The final chapters summarize soft drink marketing issues, health effects of sugar and high fructose corn syrup, beverage ingredient functions, beverage labeling regulation and the importance of trends in beverage development. These updated chapters are objectively written to emphasize peer-reviewed references and minimize the anecdotal references often seen in the current literature describing beverages and their impact on our health and nutrition. All chapters are authored by recognized authorities from industry, the health-care system, and universities. This book contains 24 concise and user-friendly chapters intended to enable readers to grasp the message quickly and easily.

Download or read book Solid Liquid Dispersions written by Bohuslav Dobias and published by CRC Press. This book was released on 1999-03-04 with total page 586 pages. Available in PDF, EPUB and Kindle. Book excerpt: Reviews a range of fundamental concepts, recent developments and practical applications in dispersion theory, along with relevant insights from colloidal and interfacial science. The text contains new work on the stabilization of solid-liquid dispersions. It focuses on topics as varied as electrostatics, hydrodynamics and rheology.

Download or read book Food Packaging Materials written by Luciano Piergiovanni and published by Springer. This book was released on 2015-11-26 with total page 78 pages. Available in PDF, EPUB and Kindle. Book excerpt: This Brief is concerned with the material chemistry of food packaging materials. It introduces the properties and peculiarities of typical packaging materials, such as plastics, cellulose components, ceramics and metals. Their overall performance as food packaging material is determined by the chemical and physical properties. The Brief describes how the final properties of a food packaging material can be influenced through chemical modifications in the structure and composition of the used components. The authors also cover potential chemical reactions of food packaging materials that may affect their performance. Potential hazards that may arise, such as influences on the product quality, or effects on their recycling or disposal, are discussed. Different influences, like metal corrosion, chemical resistance and degradability of the main packaging materials, or properties like hydrophobicity, surface energy and migration have to be taken into account. This Brief gives an introduction to all these different aspects of food packaging.

Download or read book Residue Reviews R ckstandsberichte written by Francis A. Gunther and published by Springer. This book was released on 1971-04-06 with total page 169 pages. Available in PDF, EPUB and Kindle. Book excerpt: That residues of pesticide and other "foreign" chemicals in food stuffs are of concern to everyone everywhere is amply attested by the reception accorded previous volumes of "Residue Reviews" and by the gratifying enthusiasm, sincerity, and efforts shown by all the in dividuals from whom manuscripts have been solicited. Despite much propaganda to the contrary, there can never be any serious question that pest-control chemicals and food-additive chemicals are essential to adequate food production, manufacture, marketing, and storage, yet without continuing surveillance and intelligent control some of those that persist in our foodstuffs could at times conceivably endanger the public health. Ensuring safety-in-use of these many chemicals is a dynamic challenge, for established ones are continually being dis placed by newly developed ones more acceptable to food technologists, pharmacologists, taxicologists, and changing pest-control requirements in progressive food-producing economies. These matters are of genuine concern to increasing numbers of governmental agencies and legislative bodies around the world, for some of these chemicals have resulted in a few mishaps from improper use. Adequate safety-in-use evaluations of any of these chemicals per sisting into our foodstuffs are not simple matters, and they incorporate the considered judgments of many individuals highly trained in a variety of complex biological, chemical, food technological, medical, pharmacological, and toxicological disciplines.

Download or read book Removal of Toxic Pollutants through Microbiological and Tertiary Treatment written by Maulin P. Shah and published by Elsevier. This book was released on 2020-08-20 with total page 622 pages. Available in PDF, EPUB and Kindle. Book excerpt: Removal of Toxic Pollutants through Microbiological and Tertiary Treatment: New Perspectives offers a current account of existing advanced oxidation strategies - including their limitations, challenges, and potential applications - in removing environmental pollutants through microbiological and tertiary treatment methods. The book introduces new trends and advances in environmental bioremediation technology, with thorough discussion of recent developments in the field. Updated information as well as future research directions in the field of bioremediation of industrial wastes is included. This book is an indispensable guide to students, researchers, scientists, and professionals working in fields such as microbiology, biotechnology, environmental sciences, eco-toxicology, and environmental remediation. The book also serves as a helpful guide for waste management professionals and those working on the biodegradation and bioremediation of industrial wastes and environmental pollutants for environmental sustainability. - Introduces various treatment schemes, including microbiological and tertiary technologies for bioremediation of environmental pollutants and industrial wastes - Includes pharmaceutical wastewater, oil refinery wastewater, distillery wastewater, tannery wastewater, textile wastewater, mine tailing wastes, plastic wastes, and more - Describes the role of relatively new treatment technologies and their approaches in bioremediation, including molecular and protein engineering technologies, microbial enzymes, bio surfactants, plant-microbe interactions, and genetically engineered organisms - Provides many advanced technologies in the field of bioremediation and phytoremediation, including electro-bioremediation technology, microbial fuel cell technology, nano-bioremediation technology, and phytotechnologies