Development Of An Analytical Method For Active Pharmaceutical Ingredient Assay By Near Infrared Spectroscopy

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Development of an analytical method for active pharmaceutical ingredient assay by near infrared spectroscopy

Author : Hélène Comyn
Publisher :
ISBN 13 :
Total Pages : 164 pages
Book Rating : 4.:/5 (12 download)

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Book Synopsis Development of an analytical method for active pharmaceutical ingredient assay by near infrared spectroscopy by : Hélène Comyn

Download or read book Development of an analytical method for active pharmaceutical ingredient assay by near infrared spectroscopy written by Hélène Comyn and published by . This book was released on 2020 with total page 164 pages. Available in PDF, EPUB and Kindle. Book excerpt: Les méthodes spectroscopiques sont devenues des techniques incontournables dans le milieu de la Chimie, avec un immense champ de possibilités. Parmi celles-ci, la Spectroscopie Proche Infrarouge (NIRS) est une technique analytique en plein essor dans l'industrie pharmaceutique. L'objectif du travail qui a supporté cette thèse était de développer une méthode d'analyse par spectroscopie proche infrarouge pour le dosage de principe actif dans un produit fini, à des fins de libération de lots. Cette nouvelle méthode, plus rapide, et plus économique, présente une alternative à la méthode de dosage actuelle par HPLC. Ce projet inclut le développement du modèle de calibration, la comparaison du modèle obtenu avec la méthode de référence, et la validation de la méthode selon les réglementations internes et internationales relatives aux méthodes analytiques. Cette thèse présente l'étude de faisabilité menée lors de la construction du modèle de calibration, ainsi que la stratégie de validation de la méthode et ses résultats. Une méthode analytique satisfaisante a été développée, pour deux formes différentes du produit : sous forme granules ou poudres (résultant du broyage des granules). L'analyse de données multivariées a été utilisée pour la construction du modèle. Le modèle a une précision (RMSECV) de 0.6% de la dose nominale, et a été démontré au moins équivalent à la méthode HPLC, si ce n'est meilleur en termes de précision.

Pharmaceutical and Medical Applications of Near-Infrared Spectroscopy

Author : Emil W. Ciurczak
Publisher : CRC Press
ISBN 13 : 0824743253
Total Pages : 203 pages
Book Rating : 4.8/5 (247 download)

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Book Synopsis Pharmaceutical and Medical Applications of Near-Infrared Spectroscopy by : Emil W. Ciurczak

Download or read book Pharmaceutical and Medical Applications of Near-Infrared Spectroscopy written by Emil W. Ciurczak and published by CRC Press. This book was released on 2002-02-08 with total page 203 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book discusses the theory, instrumentation, validation, and implementation of near-infrared spectroscopy for pharmaceutical and medical applications. It showcases a diverse range of contemporary methods for the production, screening, and analysis of new drug products and pharmaceuticals. Presents current approaches in near-infrared spectroscopy (NIR) to monitor and control multiple phases of the drug manufacturing process.

Pharmaceutical and Medical Applications of Near-Infrared Spectroscopy

Author : Emil W. Ciurczak
Publisher : CRC Press
ISBN 13 : 1498704468
Total Pages : 180 pages
Book Rating : 4.4/5 (987 download)

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Book Synopsis Pharmaceutical and Medical Applications of Near-Infrared Spectroscopy by : Emil W. Ciurczak

Download or read book Pharmaceutical and Medical Applications of Near-Infrared Spectroscopy written by Emil W. Ciurczak and published by CRC Press. This book was released on 2014-12-15 with total page 180 pages. Available in PDF, EPUB and Kindle. Book excerpt: Since the completion of the first edition of this book, major developments have occurred in the pharmaceutical industry that have shaped the field of near-infrared (NIR) spectroscopy. A new initiative from the U.S. Food and Drug Administration (FDA) to modernize regulations of pharmaceutical manufacturing and drug quality has helped position NIR sp

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.

Handbook of Near-Infrared Analysis

Author : Emil W. Ciurczak
Publisher : CRC Press
ISBN 13 : 1351269860
Total Pages : 1308 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 2021-05-20 with total page 1308 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.

Moisture Determination in an Active Pharmaceutical Ingredient (API) by Near Infrared Spectroscopy

Author : Orlando Rodríguez Ramos
Publisher :
ISBN 13 :
Total Pages : 238 pages
Book Rating : 4.:/5 (56 download)

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Book Synopsis Moisture Determination in an Active Pharmaceutical Ingredient (API) by Near Infrared Spectroscopy by : Orlando Rodríguez Ramos

Download or read book Moisture Determination in an Active Pharmaceutical Ingredient (API) by Near Infrared Spectroscopy written by Orlando Rodríguez Ramos and published by . This book was released on 2000 with total page 238 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Analytical Method Development and Validation

Author : Michael E. Swartz
Publisher : CRC Press
ISBN 13 : 1482229773
Total Pages : 95 pages
Book Rating : 4.4/5 (822 download)

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Book Synopsis Analytical Method Development and Validation by : Michael E. Swartz

Download or read book Analytical Method Development and Validation written by Michael E. Swartz and published by CRC Press. This book was released on 2018-10-03 with total page 95 pages. Available in PDF, EPUB and Kindle. Book excerpt: Describes analytical methods development, optimization and validation, and provides examples of successful methods development and validation in high-performance liquid chromatography (HPLC) areas. The text presents an overview of Food and Drug Administration (FDA)/International Conference on Harmonization (ICH) regulatory guidelines, compliance with validation requirements for regulatory agencies, and methods validation criteria stipulated by the US Pharmacopia, FDA and ICH.

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:

Pharmaceutical Analysis E-Book

Author : David G. Watson
Publisher : Elsevier Health Sciences
ISBN 13 : 0702051292
Total Pages : 441 pages
Book Rating : 4.7/5 (2 download)

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Book Synopsis Pharmaceutical Analysis E-Book by : David G. Watson

Download or read book Pharmaceutical Analysis E-Book written by David G. Watson and published by Elsevier Health Sciences. This book was released on 2012-07-15 with total page 441 pages. Available in PDF, EPUB and Kindle. Book excerpt: An introductory text, written with the needs of the student in mind, which explains all the most important techniques used in the analysis of pharmaceuticals - a key procedure in ensuring the quality of drugs . The text is enhanced throughout with keypoints and self-assessment boxes, to aid student learning. Features Includes worked calculations to demonstrate mathematics in use for pharmaceutical analysis. Focuses on key points rather than a large number of facts to help readers really understand the field as well as pass exams. Includes self-assessment, focussing on simple arithmetical calculation results from analytical data. Additional section on basic calculations in pharmaceutical analysis More detail on the capillary electrophoresis of proteins A discussion of some of the new types of HPLC column and on solvent selectivity in HPLC Additional material inserted on the control of the quality of analytical methods, mass spectrometry and high pressure liquid chromatography Additional self-assessment exercises

Near-infrared Spectroscopic Assay Transfer for Active Pharmaceutical Ingredients in Intact Tablets

Author :
Publisher :
ISBN 13 :
Total Pages : 626 pages
Book Rating : 4.:/5 (926 download)

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Book Synopsis Near-infrared Spectroscopic Assay Transfer for Active Pharmaceutical Ingredients in Intact Tablets by :

Download or read book Near-infrared Spectroscopic Assay Transfer for Active Pharmaceutical Ingredients in Intact Tablets written by and published by . This book was released on 2005 with total page 626 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Pharmaceutical Analysis E-Book

Author : David G. Watson
Publisher : Elsevier Health Sciences
ISBN 13 : 0702078093
Total Pages : 475 pages
Book Rating : 4.7/5 (2 download)

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Book Synopsis Pharmaceutical Analysis E-Book by : David G. Watson

Download or read book Pharmaceutical Analysis E-Book written by David G. Watson and published by Elsevier Health Sciences. This book was released on 2020-06-10 with total page 475 pages. Available in PDF, EPUB and Kindle. Book excerpt: Pharmaceutical analysis determines the purity, concentration, active compounds, shelf life, rate of absorption in the body, identity, stability, rate of release etc. of a drug. Testing a pharmaceutical product involves a variety of analyses, and the analytical processes described in this book are used in industries as diverse as food, beverages, cosmetics, detergents, metals, paints, water, agrochemicals, biotechnological products and pharmaceuticals.The mathematics involved is notoriously difficult, but this much-praised and well established textbook, now revised and updated for its fifth edition, guides a student through the complexities with clear writing and the author's expertise from many years' teaching pharmacy students. Worked calculation examples and self-assessment test questions aid continuous learning reinforcement throughout Frequent use of figures and diagrams clarify points made in the text Practical examples are used to show the application of techniques Key points boxes summarise the need to know information for each topic Focuses on the most relevant and frequently used techniques within 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.

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

Calibration and Validation of Analytical Methods

Author : Mark Stauffer
Publisher : BoD – Books on Demand
ISBN 13 : 1789230845
Total Pages : 176 pages
Book Rating : 4.7/5 (892 download)

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Book Synopsis Calibration and Validation of Analytical Methods by : Mark Stauffer

Download or read book Calibration and Validation of Analytical Methods written by Mark Stauffer and published by BoD – Books on Demand. This book was released on 2018-04-25 with total page 176 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book seeks to introduce the reader to current methodologies in analytical calibration and validation. This collection of contributed research articles and reviews addresses current developments in the calibration of analytical methods and techniques and their subsequent validation. Section 1, "Introduction," contains the Introductory Chapter, a broad overview of analytical calibration and validation, and a brief synopsis of the following chapters. Section 2 "Calibration Approaches" presents five chapters covering calibration schemes for some modern analytical methods and techniques. The last chapter in this section provides a segue into Section 3, "Validation Approaches," which contains two chapters on validation procedures and parameters. This book is a valuable source of scientific information for anyone interested in analytical calibration and validation.

Process Analytical Technology

Author : Katherine A. Bakeev
Publisher : John Wiley & Sons
ISBN 13 : 0470689609
Total Pages : 576 pages
Book Rating : 4.4/5 (76 download)

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Book Synopsis Process Analytical Technology by : Katherine A. Bakeev

Download or read book Process Analytical Technology written by Katherine A. Bakeev and published by John Wiley & Sons. This book was released on 2010-04-01 with total page 576 pages. Available in PDF, EPUB and Kindle. Book excerpt: Process Analytical Technology explores the concepts of PAT and its application in the chemical and pharmaceutical industry from the point of view of the analytical chemist. In this new edition all of the original chapters have been updated and revised, and new chapters covering the important topics of sampling, NMR, fluorescence, and acoustic chemometrics have been added. Coverage includes: Implementation of Process Analytical Technologies UV-Visible Spectroscopy for On-line Analysis Infrared Spectroscopy for Process Analytical Applications Process Raman Spectroscopy Process NMR Spectrscopy: Technology and On-line Applications Fluorescent Sensing and Process Analytical Applications Chemometrics in Process Analytical Technology (PAT) On-Line PAT Applications of Spectroscopy in the Pharmaceutical Industry Future Trends for PAT for Increased Process Understanding and Growing Applications in Biomanufacturing NIR Chemical Imaging This volume is an important starting point for anyone wanting to implement PAT and is intended not only to assist a newcomer to the field but also to provide up-to-date information for those who practice process analytical chemistry and PAT. It is relevant for chemists, chemical and process engineers, and analytical chemists working on process development, scale-up and production in the pharmaceutical, fine and specialty chemicals industries, as well as for academic chemistry, chemical engineering, chemometrics and pharmaceutical science research groups focussing on PAT. Review from the First Edition “The book provides an excellent first port of call for anyone seeking material and discussions to understand the area better. It deserves to be found in every library that serves those who are active in the field of Process Analytical Technology.”—Current Engineering Practice

BIWIC 2007

Author : Alison Lewis
Publisher : IOS Press
ISBN 13 : 1586037900
Total Pages : 284 pages
Book Rating : 4.5/5 (86 download)

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Book Synopsis BIWIC 2007 by : Alison Lewis

Download or read book BIWIC 2007 written by Alison Lewis and published by IOS Press. This book was released on 2007 with total page 284 pages. Available in PDF, EPUB and Kindle. Book excerpt: The field of crystallization holds many challenges, with the physical and chemical complexity of the crystallization process being core to the dynamic nature of the field. Exciting advances are achieved in the areas of nanoparticle formation, product and particle design and methods of particle characterization.

Near-Infrared Spectroscopy

Author : Yukihiro Ozaki
Publisher : Springer Nature
ISBN 13 : 9811586489
Total Pages : 593 pages
Book Rating : 4.8/5 (115 download)

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Book Synopsis Near-Infrared Spectroscopy by : Yukihiro Ozaki

Download or read book Near-Infrared Spectroscopy written by Yukihiro Ozaki and published by Springer Nature. This book was released on 2020-11-13 with total page 593 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book provides knowledge of the basic theory, spectral analysis methods, chemometrics, instrumentation, and applications of near-infrared (NIR) spectroscopy—not as a handbook but rather as a sourcebook of NIR spectroscopy. Thus, some emphasis is placed on the description of basic knowledge that is important in learning and using NIR spectroscopy. The book also deals with applications for a variety of research fields that are very useful for a wide range of readers from graduate students to scientists and engineers in both academia and industry. For readers who are novices in NIR spectroscopy, this book provides a good introduction, and for those who already are familiar with the field it affords an excellent means of strengthening their knowledge about NIR spectroscopy and keeping abreast of recent developments.