Moisture Determination In An Active Pharmaceutical Ingredient Api By Near Infrared Spectroscopy

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Handbook of Near-Infrared Analysis

Author : Emil W. Ciurczak
Publisher : CRC Press
ISBN 13 : 1351269879
Total Pages : 938 pages
Book Rating : 4.3/5 (512 download)

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Book Synopsis Handbook of Near-Infrared Analysis by : Emil W. Ciurczak

Download or read book Handbook of Near-Infrared Analysis written by Emil W. Ciurczak and published by CRC Press. This book was released on 2021-05-19 with total page 938 pages. Available in PDF, EPUB and Kindle. Book excerpt: Rapid, inexpensive, and easy-to-deploy, near-infrared (NIR) spectroscopy can be used to analyze samples of virtually any composition, origin, and condition. The Handbook of Near Infrared Analysis, Fourth Edition, explores the factors necessary to perform accurate and time- and cost-effective analyses across a growing spectrum of disciplines. This updated and expanded edition incorporates the latest advances in instrumentation, computerization, chemometrics applied to NIR spectroscopy, and method development in NIR spectroscopy, and underscores current trends in sample preparation, calibration transfer, process control, data analysis, instrument performance testing, and commercial NIR instrumentation. This work offers readers an unparalleled combination of theoretical foundations, cutting-edge applications, and practical experience. Additional features include the following: Explains how to perform accurate as well as time- and cost-effective analyses. Reviews software-enabled chemometric methods and other trends in data analysis. Highlights novel applications in pharmaceuticals, polymers, plastics, petrochemicals, textiles, foods and beverages, baked products, agricultural products, biomedicine, nutraceuticals, and counterfeit detection. Underscores current trends in sample preparation, calibration transfer, process control, data analysis, and multiple aspects of commercial NIR instrumentation. Offering the most complete single-source guide of its kind, the Handbook of Near Infrared Analysis, Fourth Edition, continues to offer practicing chemists and spectroscopists an unparalleled combination of theoretical foundations, cutting-edge applications, and detailed practical experience provided firsthand by more than 50 experts in the field.

Analytical Techniques in the Pharmaceutical Sciences

Author : Anette Müllertz
Publisher : Springer
ISBN 13 : 1493940295
Total Pages : 829 pages
Book Rating : 4.4/5 (939 download)

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Book Synopsis Analytical Techniques in the Pharmaceutical Sciences by : Anette Müllertz

Download or read book Analytical Techniques in the Pharmaceutical Sciences written by Anette Müllertz and published by Springer. This book was released on 2016-08-30 with total page 829 pages. Available in PDF, EPUB and Kindle. Book excerpt: The aim of this book is to present a range of analytical methods that can be used in formulation design and development and focus on how these systems can be applied to understand formulation components and the dosage form these build. To effectively design and exploit drug delivery systems, the underlying characteristic of a dosage form must be understood--from the characteristics of the individual formulation components, to how they act and interact within the formulation, and finally, to how this formulation responds in different biological environments. To achieve this, there is a wide range of analytical techniques that can be adopted to understand and elucidate the mechanics of drug delivery and drug formulation. Such methods include e.g. spectroscopic analysis, diffractometric analysis, thermal investigations, surface analytical techniques, particle size analysis, rheological techniques, methods to characterize drug stability and release, and biological analysis in appropriate cell and animal models. Whilst each of these methods can encompass a full research area in their own right, formulation scientists must be able to effectively apply these methods to the delivery system they are considering. The information in this book is designed to support researchers in their ability to fully characterize and analyze a range of delivery systems, using an appropriate selection of analytical techniques. Due to its consideration of regulatory approval, this book will also be suitable for industrial researchers both at early stage up to pre-clinical research.

Physico Chemical Methods in Drug Discovery and Development

Author : Zoran Mandic
Publisher : IAPC Publishing
ISBN 13 : 9535694200
Total Pages : 500 pages
Book Rating : 4.5/5 (356 download)

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Book Synopsis Physico Chemical Methods in Drug Discovery and Development by : Zoran Mandic

Download or read book Physico Chemical Methods in Drug Discovery and Development written by Zoran Mandic and published by IAPC Publishing. This book was released on 2012 with total page 500 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Multivariate Analysis in the Pharmaceutical Industry

Author : Ana Patricia Ferreira
Publisher : Academic Press
ISBN 13 : 012811066X
Total Pages : 465 pages
Book Rating : 4.1/5 (281 download)

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Book Synopsis Multivariate Analysis in the Pharmaceutical Industry by : Ana Patricia Ferreira

Download or read book Multivariate Analysis in the Pharmaceutical Industry written by Ana Patricia Ferreira and published by Academic Press. This book was released on 2018-04-24 with total page 465 pages. Available in PDF, EPUB and Kindle. Book excerpt: Multivariate Analysis in the Pharmaceutical Industry provides industry practitioners with guidance on multivariate data methods and their applications over the lifecycle of a pharmaceutical product, from process development, to routine manufacturing, focusing on the challenges specific to each step. It includes an overview of regulatory guidance specific to the use of these methods, along with perspectives on the applications of these methods that allow for testing, monitoring and controlling products and processes. The book seeks to put multivariate analysis into a pharmaceutical context for the benefit of pharmaceutical practitioners, potential practitioners, managers and regulators. Users will find a resources that addresses an unmet need on how pharmaceutical industry professionals can extract value from data that is routinely collected on products and processes, especially as these techniques become more widely used, and ultimately, expected by regulators. - Targets pharmaceutical industry practitioners and regulatory staff by addressing industry specific challenges - Includes case studies from different pharmaceutical companies and across product lifecycle of to introduce readers to the breadth of applications - Contains information on the current regulatory framework which will shape how multivariate analysis (MVA) is used in years to come

Pharmaceutical Quality by Design

Author : Walkiria S. Schlindwein
Publisher : John Wiley & Sons
ISBN 13 : 1118895215
Total Pages : 319 pages
Book Rating : 4.1/5 (188 download)

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Book Synopsis Pharmaceutical Quality by Design by : Walkiria S. Schlindwein

Download or read book Pharmaceutical Quality by Design written by Walkiria S. Schlindwein and published by John Wiley & Sons. This book was released on 2018-01-05 with total page 319 pages. Available in PDF, EPUB and Kindle. Book excerpt: A practical guide to Quality by Design for pharmaceutical product development Pharmaceutical Quality by Design: A Practical Approach outlines a new and proven approach to pharmaceutical product development which is now being rolled out across the pharmaceutical industry internationally. Written by experts in the field, the text explores the QbD approach to product development. This innovative approach is based on the application of product and process understanding underpinned by a systematic methodology which can enable pharmaceutical companies to ensure that quality is built into the product. Familiarity with Quality by Design is essential for scientists working in the pharmaceutical industry. The authors take a practical approach and put the focus on the industrial aspects of the new QbD approach to pharmaceutical product development and manufacturing. The text covers quality risk management tools and analysis, applications of QbD to analytical methods, regulatory aspects, quality systems and knowledge management. In addition, the book explores the development and manufacture of drug substance and product, design of experiments, the role of excipients, multivariate analysis, and include several examples of applications of QbD in actual practice. This important resource: Covers the essential information about Quality by Design (QbD) that is at the heart of modern pharmaceutical development Puts the focus on the industrial aspects of the new QbD approach Includes several illustrative examples of applications of QbD in practice Offers advanced specialist topics that can be systematically applied to industry Pharmaceutical Quality by Design offers a guide to the principles and application of Quality by Design (QbD), the holistic approach to manufacturing that offers a complete understanding of the manufacturing processes involved, in order to yield consistent and high quality products.

Karl Fischer Titration

Author : Eugen Scholz
Publisher : Springer Science & Business Media
ISBN 13 : 3642699898
Total Pages : 142 pages
Book Rating : 4.6/5 (426 download)

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Book Synopsis Karl Fischer Titration by : Eugen Scholz

Download or read book Karl Fischer Titration written by Eugen Scholz and published by Springer Science & Business Media. This book was released on 2012-12-06 with total page 142 pages. Available in PDF, EPUB and Kindle. Book excerpt: The Karl Fischer titration is used in many different ways following its publication in 1935 and further applications are continually being explored. At the present time we are experiencing another phase of expansion, as shown by the development of new titration equipment and new reagents. KF equipment increasingly incorporates microprocessors which enable the course of a titration to be programmed thus sim plifying the titration. Coulometric titrators allow water determinations in the micro gram-range: the KF titration has become a micro-method. The new pyridine-free re agents make its application significantly more pleasant and open up further possibili ties on account of their accuracy. To make the approach to Karl Fischer titrations easier, we have summarized the present knowledge in this monograph and we have complemented it with our own studies and practical experience. As this book should remain "readable", we have tried to keep the fundamentals to a minimum. Historical developments are only mentioned if they seem to be necessary for understanding the KF reaction. The ap plications are described more fully. Specific details which may interest a particular reader can be found in the original publications cited. The referenced literature is in chronological order as the year of publication may also prove informative. Thus, [6902] for example denotes 69 for 1969 being the year of publication and 02 is a non-recurring progressive number. The referenced litera ture includes summaries which we hope will be of help to find the "right" publica tion easily.

Handbook of Validation in Pharmaceutical Processes, Fourth Edition

Author : James Agalloco
Publisher : CRC Press
ISBN 13 : 1000436012
Total Pages : 1062 pages
Book Rating : 4.0/5 (4 download)

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Book Synopsis Handbook of Validation in Pharmaceutical Processes, Fourth Edition by : James Agalloco

Download or read book Handbook of Validation in Pharmaceutical Processes, Fourth Edition written by James Agalloco and published by CRC Press. This book was released on 2021-10-28 with total page 1062 pages. Available in PDF, EPUB and Kindle. Book excerpt: Revised to reflect significant advances in pharmaceutical production and regulatory expectations, Handbook of Validation in Pharmaceutical Processes, Fourth Edition examines and blueprints every step of the validation process needed to remain compliant and competitive. This book blends the use of theoretical knowledge with recent technological advancements to achieve applied practical solutions. As the industry's leading source for validation of sterile pharmaceutical processes for more than 10 years, this greatly expanded work is a comprehensive analysis of all the fundamental elements of pharmaceutical and bio-pharmaceutical production processes. Handbook of Validation in Pharmaceutical Processes, Fourth Edition is essential for all global health care manufacturers and pharmaceutical industry professionals. Key Features: Provides an in-depth discussion of recent advances in sterilization Identifies obstacles that may be encountered at any stage of the validation program, and suggests the newest and most advanced solutions Explores distinctive and specific process steps, and identifies critical process control points to reach acceptable results New chapters include disposable systems, combination products, nano-technology, rapid microbial methods, contamination control in non-sterile products, liquid chemical sterilization, and medical device manufacture

Pharmaceutical Applications of Raman Spectroscopy

Author : Slobodan Sasic
Publisher : John Wiley & Sons
ISBN 13 : 0470225874
Total Pages : 285 pages
Book Rating : 4.4/5 (72 download)

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Book Synopsis Pharmaceutical Applications of Raman Spectroscopy by : Slobodan Sasic

Download or read book Pharmaceutical Applications of Raman Spectroscopy written by Slobodan Sasic and published by John Wiley & Sons. This book was released on 2007-10-23 with total page 285 pages. Available in PDF, EPUB and Kindle. Book excerpt: Raman spectroscopy has advanced in recent years with increasing use both in industry and academia. This is due largely to steady improvements in instrumentation, decreasing cost, and the availability of chemometrics to assist in the analysis of data. Pharmaceutical applications of Raman spectroscopy have developed similarly and this book will focus on those applications. Carefully organized with an emphasis on industry issues, Pharmaceutical Applications of Raman Spectroscopy, provides the basic theory of Raman effect and instrumentation, and then addresses a wide range of pharmaceutical applications. Current applications that are routinely used as well as those with promising potential are covered. Applications cover a broad range from discovery to manufacturing in the pharmaceutical industry and include identifying polymorphs, monitoring real-time processes, imaging solid dosage formulations, imaging active pharmaceutical ingredients in cells, and diagnostics.

Pulmonary Drug Delivery

Author : Ali Nokhodchi
Publisher : John Wiley & Sons
ISBN 13 : 111879950X
Total Pages : 384 pages
Book Rating : 4.1/5 (187 download)

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Book Synopsis Pulmonary Drug Delivery by : Ali Nokhodchi

Download or read book Pulmonary Drug Delivery written by Ali Nokhodchi and published by John Wiley & Sons. This book was released on 2015-05-18 with total page 384 pages. Available in PDF, EPUB and Kindle. Book excerpt: Drug therapy via inhalation route is at the cutting edge of modern drug delivery research. There has been significant progress on the understanding of drug therapy via inhalation products. However, there are still problems associated with their formulation design, including the interaction between the active pharmaceutical ingredient(s) (APIs), excipients and devices. This book seeks to cover some of the most pertinent issues and challenges of such formulation design associated with industrial production and desirable clinical outcome. The chapter topics have been selected with a view to integrating the factors that require consideration in the selection and design of device and formulation components which impact upon patient usability and clinical effectiveness. The challenges involved with the delivery of macromolecules by inhalation to both adult and pediatric patients are also covered. Written by leading international experts from both academia and industry, the book will help readers (formulation design scientists, researchers and post-graduate and specialized undergraduate students) develop a deep understanding of key aspects of inhalation formulations as well as detail ongoing challenges and advances associated with their development.

Introduction to Quality by Design (QbD)

Author : N. K. Jain
Publisher : Springer Nature
ISBN 13 : 9819980348
Total Pages : 505 pages
Book Rating : 4.8/5 (199 download)

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Book Synopsis Introduction to Quality by Design (QbD) by : N. K. Jain

Download or read book Introduction to Quality by Design (QbD) written by N. K. Jain and published by Springer Nature. This book was released on with total page 505 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Parenteral Medications, Fourth Edition

Author : Sandeep Nema
Publisher : CRC Press
ISBN 13 : 0429576838
Total Pages : 1145 pages
Book Rating : 4.4/5 (295 download)

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Book Synopsis Parenteral Medications, Fourth Edition by : Sandeep Nema

Download or read book Parenteral Medications, Fourth Edition written by Sandeep Nema and published by CRC Press. This book was released on 2019-07-19 with total page 1145 pages. Available in PDF, EPUB and Kindle. Book excerpt: Parenteral Medications is an authoritative, comprehensive reference work on the formulation and manufacturing of parenteral dosage forms, effectively balancing theoretical considerations with practical aspects of their development. Previously published as a three-volume set, all volumes have been combined into one comprehensive publication that addresses the plethora of changes in the science and considerable advances in the technology associated with these products and routes of administration. Key Features: Provides a comprehensive reference work on the formulation and manufacturing of parenteral dosage forms Addresses changes in the science and advances in the technology associated with parenteral medications and routes of administration Includes 13 new chapters and updated chapters throughout Contains the contributors of leading researchers in the field of parenteral medications Uses full color detailed illustrations, enhancing the learning process The fourth edition not only reflects enhanced content in all the chapters but also highlights the rapidly advancing formulation, processing, manufacturing parenteral technology including advanced delivery and cell therapies. The book is divided into seven sectionss: Section 1 - Parenteral Drug Administration and Delivery Devices; Section 2 - Formulation Design and Development; Section 3 - Specialized Drug Delivery Systems; Section 4 - Primary Packaging and Container Closure Integrity; Section 5 - Facility Design and Environmental Control; Section 6 - Sterilization and Pharmaceutical Processing; Section 7 - Quality Testing and Regulatory Requirements

Directory of Graduate Research

Author :
Publisher :
ISBN 13 :
Total Pages : 1846 pages
Book Rating : 4.:/5 (318 download)

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Book Synopsis Directory of Graduate Research by :

Download or read book Directory of Graduate Research written by and published by . This book was released on 2001 with total page 1846 pages. Available in PDF, EPUB and Kindle. Book excerpt: Faculties, publications and doctoral theses in departments or divisions of chemistry, chemical engineering, biochemistry and pharmaceutical and/or medicinal chemistry at universities in the United States and Canada.

Development and Validation of Analytical Methods

Author : Christopher M. Riley
Publisher : Elsevier
ISBN 13 : 0080530354
Total Pages : 363 pages
Book Rating : 4.0/5 (85 download)

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Book Synopsis Development and Validation of Analytical Methods by : Christopher M. Riley

Download or read book Development and Validation of Analytical Methods written by Christopher M. Riley and published by Elsevier. This book was released on 1996-05-29 with total page 363 pages. Available in PDF, EPUB and Kindle. Book excerpt: The need to validate an analytical or bioanalytical method is encountered by analysts in the pharmaceutical industry on an almost daily basis, because adequately validated methods are a necessity for approvable regulatory filings. What constitutes a validated method, however, is subject to analyst interpretation because there is no universally accepted industry practice for assay validation. This book is intended to serve as a guide to the analyst in terms of the issues and parameters that must be considered in the development and validation of analytical methods. In addition to the critical issues surrounding method validation, this book also deals with other related factors such as method development, data acquisition, automation, cleaning validation and regulatory considerations. The book is divided into three parts. Part One, comprising two chapters, looks at some of the basic concepts of method validation. Chapter 1 discusses the general concept of validation and its role in the process of transferring methods from laboratory to laboratory. Chapter 2 looks at some of the critical parameters included in a validation program and the various statistical treatments given to these parameters.Part Two (Chapters 3, 4 and 5) of the book focuses on the regulatory perspective of analytical validation. Chapter 3 discusses in some detail how validation is treated by various regulatory agencies around the world, including the United States, Canada, the European Community, Australia and Japan. This chapter also discusses the International Conference on Harmonization (ICH) treatment of assay validation. Chapters 4 and 5 cover the issues and various perspectives of the recent United States vs. Barr Laboratories Inc. case involving the retesting of samples. Part Three (Chapters 6 - 12) covers the development and validation of various analytical components of the pharmaceutical product development process. This part of the book contains specific chapters dedicated to bulk drug substances and finished products, dissolution studies, robotics and automated workstations, biotechnology products, biological samples, analytical methods for cleaning procedures and computer systems and computer-aided validation. Each chapter goes into some detail describing the critical development and related validation considerations for each topic.This book is not intended to be a practical description of the analytical validation process, but more of a guide to the critical parameters and considerations that must be attended to in a pharmaceutical development program. Despite the existence of numerous guidelines including the recent attempts by the ICH to be implemented in 1998, the practical part of assay validation will always remain, to a certain extent, a matter of the personal preference of the analyst or company. Nevertheless, this book brings together the perspectives of several experts having extensive experience in different capacities in the pharmaceutical industry in an attempt to bring some consistency to analytical method development and validation.

Applications of Vibrational Spectroscopy in Pharmaceutical Research and Development

Author : Don E. Pivonka
Publisher : Wiley-Blackwell
ISBN 13 : 9780470712412
Total Pages : 0 pages
Book Rating : 4.7/5 (124 download)

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Book Synopsis Applications of Vibrational Spectroscopy in Pharmaceutical Research and Development by : Don E. Pivonka

Download or read book Applications of Vibrational Spectroscopy in Pharmaceutical Research and Development written by Don E. Pivonka and published by Wiley-Blackwell. This book was released on 2008-04-23 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Developing Solid Oral Dosage Forms

Author : Yihong Qiu
Publisher : Academic Press
ISBN 13 : 0128026375
Total Pages : 1178 pages
Book Rating : 4.1/5 (28 download)

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Book Synopsis Developing Solid Oral Dosage Forms by : Yihong Qiu

Download or read book Developing Solid Oral Dosage Forms written by Yihong Qiu and published by Academic Press. This book was released on 2016-11-08 with total page 1178 pages. Available in PDF, EPUB and Kindle. Book excerpt: Developing Solid Oral Dosage Forms: Pharmaceutical Theory and Practice, Second Edition illustrates how to develop high-quality, safe, and effective pharmaceutical products by discussing the latest techniques, tools, and scientific advances in preformulation investigation, formulation, process design, characterization, scale-up, and production operations. This book covers the essential principles of physical pharmacy, biopharmaceutics, and industrial pharmacy, and their application to the research and development process of oral dosage forms. Chapters have been added, combined, deleted, and completely revised as necessary to produce a comprehensive, well-organized, valuable reference for industry professionals and academics engaged in all aspects of the development process. New and important topics include spray drying, amorphous solid dispersion using hot-melt extrusion, modeling and simulation, bioequivalence of complex modified-released dosage forms, biowaivers, and much more. - Written and edited by an international team of leading experts with experience and knowledge across industry, academia, and regulatory settings - Includes new chapters covering the pharmaceutical applications of surface phenomenon, predictive biopharmaceutics and pharmacokinetics, the development of formulations for drug discovery support, and much more - Presents new case studies throughout, and a section completely devoted to regulatory aspects, including global product regulation and international perspectives

Chemical Engineering in the Pharmaceutical Industry

Author : Mary T. am Ende
Publisher : John Wiley & Sons
ISBN 13 : 1119285518
Total Pages : 686 pages
Book Rating : 4.1/5 (192 download)

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Book Synopsis Chemical Engineering in the Pharmaceutical Industry by : Mary T. am Ende

Download or read book Chemical Engineering in the Pharmaceutical Industry written by Mary T. am Ende and published by John Wiley & Sons. This book was released on 2019-04-01 with total page 686 pages. Available in PDF, EPUB and Kindle. Book excerpt: A guide to the important chemical engineering concepts for the development of new drugs, revised second edition The revised and updated second edition of Chemical Engineering in the Pharmaceutical Industry offers a guide to the experimental and computational methods related to drug product design and development. The second edition has been greatly expanded and covers a range of topics related to formulation design and process development of drug products. The authors review basic analytics for quantitation of drug product quality attributes, such as potency, purity, content uniformity, and dissolution, that are addressed with consideration of the applied statistics, process analytical technology, and process control. The 2nd Edition is divided into two separate books: 1) Active Pharmaceutical Ingredients (API’s) and 2) Drug Product Design, Development and Modeling. The contributors explore technology transfer and scale-up of batch processes that are exemplified experimentally and computationally. Written for engineers working in the field, the book examines in-silico process modeling tools that streamline experimental screening approaches. In addition, the authors discuss the emerging field of continuous drug product manufacturing. This revised second edition: Contains 21 new or revised chapters, including chapters on quality by design, computational approaches for drug product modeling, process design with PAT and process control, engineering challenges and solutions Covers chemistry and engineering activities related to dosage form design, and process development, and scale-up Offers analytical methods and applied statistics that highlight drug product quality attributes as design features Presents updated and new example calculations and associated solutions Includes contributions from leading experts in the field Written for pharmaceutical engineers, chemical engineers, undergraduate and graduation students, and professionals in the field of pharmaceutical sciences and manufacturing, Chemical Engineering in the Pharmaceutical Industry, Second Edition contains information designed to be of use from the engineer's perspective and spans information from solid to semi-solid to lyophilized drug products.

Handbook of Pharmaceutical Manufacturing Formulations, Third Edition

Author : Sarfaraz K. Niazi
Publisher : CRC Press
ISBN 13 : 1351593595
Total Pages : 602 pages
Book Rating : 4.3/5 (515 download)

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Book Synopsis Handbook of Pharmaceutical Manufacturing Formulations, Third Edition by : Sarfaraz K. Niazi

Download or read book Handbook of Pharmaceutical Manufacturing Formulations, Third Edition written by Sarfaraz K. Niazi and published by CRC Press. This book was released on 2019-11-25 with total page 602 pages. Available in PDF, EPUB and Kindle. Book excerpt: The Handbook of Pharmaceutical Manufacturing Formulations, Third Edition: Volume Two, Uncompressed Solid Products is an authoritative and practical guide to the art and science of formulating drugs for commercial manufacturing. With thoroughly revised and expanded content, this second volume of a six-volume set, compiles data from FDA and EMA new drug applications, patents and patent applications, and other sources of generic and proprietary formulations including author’s own experience, to cover the broad spectrum of cGMP formulations and issues in using these formulations in a commercial setting. A must-have collection for pharmaceutical manufacturers, educational institutions, and regulatory authorities, this is an excellent platform for drug companies to benchmark their products and for generic companies to formulate drugs coming off patent. Features:  Largest source of authoritative and practical formulations, cGMP compliance guidance and self-audit suggestions  Differs from other publications on formulation science in that it focuses on readily scalable commercial formulations that can be adopted for cGMP manufacturing  Tackles common difficulties in formulating drugs and presents details on stability testing, bioequivalence testing, and full compliance with drug product safety elements  Written by a well-recognized authority on drug and dosage form development including biological drugs and alternative medicines