Author: Janusz Pawliszyn
Publisher: Wiley-Blackwell
ISBN: 9780813823621
Category : Science
Languages : en
Pages : 480
Book Description
Discover new keys to solving analytical problems using the Latest sample preparation methods Commonly viewed of as a routine task rather than as an integral component in the analytical process, sample preparation has long been undervalued as a science and underdeveloped as a technology. In an effort to reverse this trend, Handbook of Sample Preparation shows why sample preparation deserves closer scientific scrutiny, and makes a compelling case for colleges and professional laboratories to devote more resources to promote the benefits of its correct application. Handbook of Sample Preparation includes: A solid overview of standard sampling methodologies and their analytical capabilities An introduction of non-traditional sampling technologies, which address the need for solvent-free alternatives, automation, and miniaturization A discussion of the analytical shift toward performing sampling on-site, rather than in the laboratory An examination of various extraction technologies and their applications for different types of matrices A look at how to take advantage of new sampling strategies to streamline laboratory procedures, reduce research costs, and increase overall productivity An excellent primer on the fundamentals of extraction as well as a sound guide on the latest technological upgrades influencing current sampling techniques, this versatile text serves as an important and accessible tool for both students and seasoned practitioners as they seek new avenues for improving the accuracy of their analyses.
Handbook of Sample Preparation
Author: Janusz Pawliszyn
Publisher: Wiley-Blackwell
ISBN: 9780813823621
Category : Science
Languages : en
Pages : 480
Book Description
Discover new keys to solving analytical problems using the Latest sample preparation methods Commonly viewed of as a routine task rather than as an integral component in the analytical process, sample preparation has long been undervalued as a science and underdeveloped as a technology. In an effort to reverse this trend, Handbook of Sample Preparation shows why sample preparation deserves closer scientific scrutiny, and makes a compelling case for colleges and professional laboratories to devote more resources to promote the benefits of its correct application. Handbook of Sample Preparation includes: A solid overview of standard sampling methodologies and their analytical capabilities An introduction of non-traditional sampling technologies, which address the need for solvent-free alternatives, automation, and miniaturization A discussion of the analytical shift toward performing sampling on-site, rather than in the laboratory An examination of various extraction technologies and their applications for different types of matrices A look at how to take advantage of new sampling strategies to streamline laboratory procedures, reduce research costs, and increase overall productivity An excellent primer on the fundamentals of extraction as well as a sound guide on the latest technological upgrades influencing current sampling techniques, this versatile text serves as an important and accessible tool for both students and seasoned practitioners as they seek new avenues for improving the accuracy of their analyses.
Publisher: Wiley-Blackwell
ISBN: 9780813823621
Category : Science
Languages : en
Pages : 480
Book Description
Discover new keys to solving analytical problems using the Latest sample preparation methods Commonly viewed of as a routine task rather than as an integral component in the analytical process, sample preparation has long been undervalued as a science and underdeveloped as a technology. In an effort to reverse this trend, Handbook of Sample Preparation shows why sample preparation deserves closer scientific scrutiny, and makes a compelling case for colleges and professional laboratories to devote more resources to promote the benefits of its correct application. Handbook of Sample Preparation includes: A solid overview of standard sampling methodologies and their analytical capabilities An introduction of non-traditional sampling technologies, which address the need for solvent-free alternatives, automation, and miniaturization A discussion of the analytical shift toward performing sampling on-site, rather than in the laboratory An examination of various extraction technologies and their applications for different types of matrices A look at how to take advantage of new sampling strategies to streamline laboratory procedures, reduce research costs, and increase overall productivity An excellent primer on the fundamentals of extraction as well as a sound guide on the latest technological upgrades influencing current sampling techniques, this versatile text serves as an important and accessible tool for both students and seasoned practitioners as they seek new avenues for improving the accuracy of their analyses.
Handbook of Sample Preparation for Scanning Electron Microscopy and X-Ray Microanalysis
Author: Patrick Echlin
Publisher: Springer Science & Business Media
ISBN: 0387857311
Category : Technology & Engineering
Languages : en
Pages : 329
Book Description
Scanning electr on microscopy (SEM) and x-ray microanalysis can produce magnified images and in situ chemical information from virtually any type of specimen. The two instruments generally operate in a high vacuum and a very dry environment in order to produce the high energy beam of electrons needed for imaging and analysis. With a few notable exceptions, most specimens destined for study in the SEM are poor conductors and composed of beam sensitive light elements containing variable amounts of water. In the SEM, the imaging system depends on the specimen being sufficiently electrically conductive to ensure that the bulk of the incoming electrons go to ground. The formation of the image depends on collecting the different signals that are scattered as a consequence of the high energy beam interacting with the sample. Backscattered electrons and secondary electrons are generated within the primary beam-sample interactive volume and are the two principal signals used to form images. The backscattered electron coefficient ( ? ) increases with increasing atomic number of the specimen, whereas the secondary electron coefficient ( ? ) is relatively insensitive to atomic number. This fundamental diff- ence in the two signals can have an important effect on the way samples may need to be prepared. The analytical system depends on collecting the x-ray photons that are generated within the sample as a consequence of interaction with the same high energy beam of primary electrons used to produce images.
Publisher: Springer Science & Business Media
ISBN: 0387857311
Category : Technology & Engineering
Languages : en
Pages : 329
Book Description
Scanning electr on microscopy (SEM) and x-ray microanalysis can produce magnified images and in situ chemical information from virtually any type of specimen. The two instruments generally operate in a high vacuum and a very dry environment in order to produce the high energy beam of electrons needed for imaging and analysis. With a few notable exceptions, most specimens destined for study in the SEM are poor conductors and composed of beam sensitive light elements containing variable amounts of water. In the SEM, the imaging system depends on the specimen being sufficiently electrically conductive to ensure that the bulk of the incoming electrons go to ground. The formation of the image depends on collecting the different signals that are scattered as a consequence of the high energy beam interacting with the sample. Backscattered electrons and secondary electrons are generated within the primary beam-sample interactive volume and are the two principal signals used to form images. The backscattered electron coefficient ( ? ) increases with increasing atomic number of the specimen, whereas the secondary electron coefficient ( ? ) is relatively insensitive to atomic number. This fundamental diff- ence in the two signals can have an important effect on the way samples may need to be prepared. The analytical system depends on collecting the x-ray photons that are generated within the sample as a consequence of interaction with the same high energy beam of primary electrons used to produce images.
Sample Preparation Handbook for Transmission Electron Microscopy
Author: Jeanne Ayache
Publisher: Springer Science & Business Media
ISBN: 0387981829
Category : Technology & Engineering
Languages : en
Pages : 267
Book Description
Successful transmission electron microscopy in all of its manifestations depends on the quality of the specimens examined. Biological specimen preparation protocols have usually been more rigorous and time consuming than those in the physical sciences. For this reason, there has been a wealth of scienti?c literature detailing speci?c preparation steps and numerous excellent books on the preparation of b- logical thin specimens. This does not mean to imply that physical science specimen preparation is trivial. For the most part, most physical science thin specimen pre- ration protocols can be executed in a matter of a few hours using straightforward steps. Over the years, there has been a steady stream of papers written on various aspects of preparing thin specimens from bulk materials. However, aside from s- eral seminal textbooks and a series of book compilations produced by the Material Research Society in the 1990s, no recent comprehensive books on thin spe- men preparation have appeared until this present work, ?rst in French and now in English. Everyone knows that the data needed to solve a problem quickly are more imp- tant than ever. A modern TEM laboratory with supporting SEMs, light microscopes, analytical spectrometers, computers, and specimen preparation equipment is an investment of several million US dollars. Fifty years ago, electropolishing, chemical polishing, and replication methods were the principal specimen preparation me- ods.
Publisher: Springer Science & Business Media
ISBN: 0387981829
Category : Technology & Engineering
Languages : en
Pages : 267
Book Description
Successful transmission electron microscopy in all of its manifestations depends on the quality of the specimens examined. Biological specimen preparation protocols have usually been more rigorous and time consuming than those in the physical sciences. For this reason, there has been a wealth of scienti?c literature detailing speci?c preparation steps and numerous excellent books on the preparation of b- logical thin specimens. This does not mean to imply that physical science specimen preparation is trivial. For the most part, most physical science thin specimen pre- ration protocols can be executed in a matter of a few hours using straightforward steps. Over the years, there has been a steady stream of papers written on various aspects of preparing thin specimens from bulk materials. However, aside from s- eral seminal textbooks and a series of book compilations produced by the Material Research Society in the 1990s, no recent comprehensive books on thin spe- men preparation have appeared until this present work, ?rst in French and now in English. Everyone knows that the data needed to solve a problem quickly are more imp- tant than ever. A modern TEM laboratory with supporting SEMs, light microscopes, analytical spectrometers, computers, and specimen preparation equipment is an investment of several million US dollars. Fifty years ago, electropolishing, chemical polishing, and replication methods were the principal specimen preparation me- ods.
Sample Preparation Handbook for Transmission Electron Microscopy
Author: Jeanne Ayache
Publisher: Springer Science & Business Media
ISBN: 9781441959744
Category : Technology & Engineering
Languages : en
Pages : 338
Book Description
Successful transmission electron microscopy in all of its manifestations depends on the quality of the specimens examined. Biological specimen preparation protocols have usually been more rigorous and time consuming than those in the physical sciences. For this reason, there has been a wealth of scienti c literature detailing speci c preparation steps and numerous excellent books on the preparation of b- logical thin specimens. This does not mean to imply that physical science specimen preparation is trivial. For the most part, most physical science thin specimen pre- ration protocols can be executed in a matter of a few hours using straightforward steps. Over the years, there has been a steady stream of papers written on various aspects of preparing thin specimens from bulk materials. However, aside from s- eral seminal textbooks and a series of book compilations produced by the Material Research Society in the 1990s, no recent comprehensive books on thin specimen preparation have appeared until this present work, rst in French and now in English. Everyone knows that the data needed to solve a problem quickly are more imp- tant than ever. A modern TEM laboratory with supporting SEMs, light microscopes, analytical spectrometers, computers, and specimen preparation equipment is an investment of several million US dollars. Fifty years ago, electropolishing, chemical polishing, and replication methods were the principal specimen preparation me- ods.
Publisher: Springer Science & Business Media
ISBN: 9781441959744
Category : Technology & Engineering
Languages : en
Pages : 338
Book Description
Successful transmission electron microscopy in all of its manifestations depends on the quality of the specimens examined. Biological specimen preparation protocols have usually been more rigorous and time consuming than those in the physical sciences. For this reason, there has been a wealth of scienti c literature detailing speci c preparation steps and numerous excellent books on the preparation of b- logical thin specimens. This does not mean to imply that physical science specimen preparation is trivial. For the most part, most physical science thin specimen pre- ration protocols can be executed in a matter of a few hours using straightforward steps. Over the years, there has been a steady stream of papers written on various aspects of preparing thin specimens from bulk materials. However, aside from s- eral seminal textbooks and a series of book compilations produced by the Material Research Society in the 1990s, no recent comprehensive books on thin specimen preparation have appeared until this present work, rst in French and now in English. Everyone knows that the data needed to solve a problem quickly are more imp- tant than ever. A modern TEM laboratory with supporting SEMs, light microscopes, analytical spectrometers, computers, and specimen preparation equipment is an investment of several million US dollars. Fifty years ago, electropolishing, chemical polishing, and replication methods were the principal specimen preparation me- ods.
Handbook of Solid Phase Microextraction
Author: Janusz Pawliszyn
Publisher: Elsevier
ISBN: 0123914493
Category : Science
Languages : en
Pages : 497
Book Description
The relatively new technique of solid phase microextraction (SPME) is an important tool to prepare samples both in the lab and on-site. SPME is a "green" technology because it eliminates organic solvents from analytical laboratory and can be used in environmental, food and fragrance, and forensic and drug analysis. This handbook offers a thorough background of the theory and practical implementation of SPME. SPME protocols are presented outlining each stage of the method and providing useful tips and potential pitfalls. In addition, devices and fiber coatings, automated SPME systems, SPME method development, and In Vivo applications are discussed. This handbook is essential for its discussion of the latest SPME developments as well as its in depth information on the history, theory, and practical application of the method. - Practical application of Solid Phase Microextraction methods including detailed steps - Provides history of extraction methods to better understand the process - Suitable for all levels, from beginning student to experienced practitioner
Publisher: Elsevier
ISBN: 0123914493
Category : Science
Languages : en
Pages : 497
Book Description
The relatively new technique of solid phase microextraction (SPME) is an important tool to prepare samples both in the lab and on-site. SPME is a "green" technology because it eliminates organic solvents from analytical laboratory and can be used in environmental, food and fragrance, and forensic and drug analysis. This handbook offers a thorough background of the theory and practical implementation of SPME. SPME protocols are presented outlining each stage of the method and providing useful tips and potential pitfalls. In addition, devices and fiber coatings, automated SPME systems, SPME method development, and In Vivo applications are discussed. This handbook is essential for its discussion of the latest SPME developments as well as its in depth information on the history, theory, and practical application of the method. - Practical application of Solid Phase Microextraction methods including detailed steps - Provides history of extraction methods to better understand the process - Suitable for all levels, from beginning student to experienced practitioner
Sample Preparation in LC-MS Bioanalysis
Author: Wenkui Li
Publisher: John Wiley & Sons
ISBN: 111927429X
Category : Science
Languages : en
Pages : 384
Book Description
Revised and Expanded Handbook Provides Comprehensive Introduction and Complete Instruction for Sample Preparation in Vital Category of Bioanalysis Following in the footsteps of the previously published Handbook of LC-MS Bioanalysis, this book is a thorough and timely guide to all important sample preparation techniques used for quantitative Liquid Chromatography–Mass Spectrometry (LC-MS) bioanalysis of small and large molecules. LC-MS bioanalysis is a key element of pharmaceutical research and development, post-approval therapeutic drug monitoring, and many other studies used in human healthcare. While advances are continually being made in key aspects of LC-MS bioanalysis such as sensitivity and throughput, the value of research/study mentioned above is still heavily dependent on the availability of high-quality data, for which sample preparation plays the critical role. Thus, this text provides researchers in industry, academia, and regulatory agencies with detailed sample preparation techniques and step-by-step protocols on proper extraction of various analyte(s) of interest from biological samples for LC-MS quantification, in accordance with current health authority regulations and industry best practices. The three sections of the book with a total of 26 chapters cover topics that include: Current basic sample preparation techniques (e.g., protein precipitation, liquid-liquid extraction, solid-phase extraction, salting-out assisted liquid-liquid extraction, ultracentrifugation and ultrafiltration, microsampling, sample extraction via electromembranes) Sample preparation techniques for uncommon biological matrices (e.g., tissues, hair, skin, nails, bones, mononuclear cells, cerebrospinal fluid, aqueous humor) Crucial aspects of LC-MS bioanalytical method development (e.g., pre-analytical considerations, derivation strategies, stability, non-specific binding) in addition to sample preparation techniques for challenging molecules (e.g., lipids, peptides, proteins, oligonucleotides, antibody-drug conjugates) Sample Preparation in LC-MS Bioanalysis will prove a practical and highly valuable addition to the reference shelves of scientists and related professionals in a variety of fields, including pharmaceutical and biomedical research, mass spectrometry, and analytical chemistry, as well as practitioners in clinical pharmacology, toxicology, and therapeutic drug monitoring.
Publisher: John Wiley & Sons
ISBN: 111927429X
Category : Science
Languages : en
Pages : 384
Book Description
Revised and Expanded Handbook Provides Comprehensive Introduction and Complete Instruction for Sample Preparation in Vital Category of Bioanalysis Following in the footsteps of the previously published Handbook of LC-MS Bioanalysis, this book is a thorough and timely guide to all important sample preparation techniques used for quantitative Liquid Chromatography–Mass Spectrometry (LC-MS) bioanalysis of small and large molecules. LC-MS bioanalysis is a key element of pharmaceutical research and development, post-approval therapeutic drug monitoring, and many other studies used in human healthcare. While advances are continually being made in key aspects of LC-MS bioanalysis such as sensitivity and throughput, the value of research/study mentioned above is still heavily dependent on the availability of high-quality data, for which sample preparation plays the critical role. Thus, this text provides researchers in industry, academia, and regulatory agencies with detailed sample preparation techniques and step-by-step protocols on proper extraction of various analyte(s) of interest from biological samples for LC-MS quantification, in accordance with current health authority regulations and industry best practices. The three sections of the book with a total of 26 chapters cover topics that include: Current basic sample preparation techniques (e.g., protein precipitation, liquid-liquid extraction, solid-phase extraction, salting-out assisted liquid-liquid extraction, ultracentrifugation and ultrafiltration, microsampling, sample extraction via electromembranes) Sample preparation techniques for uncommon biological matrices (e.g., tissues, hair, skin, nails, bones, mononuclear cells, cerebrospinal fluid, aqueous humor) Crucial aspects of LC-MS bioanalytical method development (e.g., pre-analytical considerations, derivation strategies, stability, non-specific binding) in addition to sample preparation techniques for challenging molecules (e.g., lipids, peptides, proteins, oligonucleotides, antibody-drug conjugates) Sample Preparation in LC-MS Bioanalysis will prove a practical and highly valuable addition to the reference shelves of scientists and related professionals in a variety of fields, including pharmaceutical and biomedical research, mass spectrometry, and analytical chemistry, as well as practitioners in clinical pharmacology, toxicology, and therapeutic drug monitoring.
Bioanalytical Separations
Author:
Publisher: Elsevier
ISBN: 0080527868
Category : Science
Languages : en
Pages : 442
Book Description
Bioanalytical Separations is volume 4 of the multi-volume series, Handbook of Analytical Separations, providing reviews of analytical separation methods and techniques used for the determination of analytes across a whole range of applications. The theme for this volume is bioanalysis, in this case specifically meaning the analysis of drugs and their metabolites in biological fluids.- Discusses new developments in instrumentation and methods of analyzing drugs and their metabolites in biological fluids - Provides guidance to the different methods, their relative value to the user, and the advantages and pitfalls of their use - Future trends are identified, in terms of the potential impact of new technologies
Publisher: Elsevier
ISBN: 0080527868
Category : Science
Languages : en
Pages : 442
Book Description
Bioanalytical Separations is volume 4 of the multi-volume series, Handbook of Analytical Separations, providing reviews of analytical separation methods and techniques used for the determination of analytes across a whole range of applications. The theme for this volume is bioanalysis, in this case specifically meaning the analysis of drugs and their metabolites in biological fluids.- Discusses new developments in instrumentation and methods of analyzing drugs and their metabolites in biological fluids - Provides guidance to the different methods, their relative value to the user, and the advantages and pitfalls of their use - Future trends are identified, in terms of the potential impact of new technologies
Drug Monitoring and Clinical Chemistry
Author: Georg Hempel
Publisher: Elsevier
ISBN: 0080530540
Category : Science
Languages : en
Pages : 379
Book Description
Drug Monitoring and Clinical Chemistry, the 5th volume in the Handbook of Analytical Separations series, gives an overview about methods to analyse drugs in biological fluids. The most widely used methods to analyse drugs in biological fluids. i.e. chromatographic methods, CE and immunoassays are described in detail. For important drugs, an overview about the methods available and a comparison of the techniques should be given to enable the reader to choose the right method depending on laboratory equipment, staff, the aim of the investigation etc. Other general aspects important for conducting therapeutic drug monitoring or pharmacokinetics studies are also covered, i.e. sample preparation, validation of the analytical methods and pharmacokinetic methods for interpreting the data. Areas where therapeutic drug monitoring is used frequently such as antibiotics, immunosuppressant drugs, antipsychotic and anticancer drugs will be discussed in detail. In addition, the important field of phenotyping and genotyping for therapy optimisation with special focus on real-life applications is also covered. The book contains important information for analyst working on drug analysis in clinical chemistry, hospital pharmacists involved in therapeutic drug monitoring, other pharmacists, chemists or physicians working on pharmacokinetic studies in industry or academia. In contrast to other books in this field, this book provides up-to-date information regarding both methodology and clinical applications. For the applications, only fields are described where therapeutic drug monitoring is used in clinical routine and provides benefit to the patients. - Overview of all important field where therapeutic drug monitoring is applied - All relevant analytical and computational methods are discussed - Written by experts with a lot of practical experience in the field
Publisher: Elsevier
ISBN: 0080530540
Category : Science
Languages : en
Pages : 379
Book Description
Drug Monitoring and Clinical Chemistry, the 5th volume in the Handbook of Analytical Separations series, gives an overview about methods to analyse drugs in biological fluids. The most widely used methods to analyse drugs in biological fluids. i.e. chromatographic methods, CE and immunoassays are described in detail. For important drugs, an overview about the methods available and a comparison of the techniques should be given to enable the reader to choose the right method depending on laboratory equipment, staff, the aim of the investigation etc. Other general aspects important for conducting therapeutic drug monitoring or pharmacokinetics studies are also covered, i.e. sample preparation, validation of the analytical methods and pharmacokinetic methods for interpreting the data. Areas where therapeutic drug monitoring is used frequently such as antibiotics, immunosuppressant drugs, antipsychotic and anticancer drugs will be discussed in detail. In addition, the important field of phenotyping and genotyping for therapy optimisation with special focus on real-life applications is also covered. The book contains important information for analyst working on drug analysis in clinical chemistry, hospital pharmacists involved in therapeutic drug monitoring, other pharmacists, chemists or physicians working on pharmacokinetic studies in industry or academia. In contrast to other books in this field, this book provides up-to-date information regarding both methodology and clinical applications. For the applications, only fields are described where therapeutic drug monitoring is used in clinical routine and provides benefit to the patients. - Overview of all important field where therapeutic drug monitoring is applied - All relevant analytical and computational methods are discussed - Written by experts with a lot of practical experience in the field
Handbook of GC-MS
Author: Hans-Joachim Hubschmann
Publisher: John Wiley & Sons
ISBN: 3527334742
Category : Science
Languages : en
Pages : 884
Book Description
The only comprehensive reference on this popular and rapidly developing technique provides a detailed overview, ranging from fundamentals to applications, including a section on the evaluation of GC-MS analyses. As such, it covers all aspects, including the theory and principles, as well as a broad range of real-life examples taken from laboratories in environmental, food, pharmaceutical and clinical analysis. It also features a glossary of approximately 300 terms and a substance index that facilitates finding a specific application. The first two editions were very well received, making this handbook a must-have in all analytical laboratories using GC-MS.
Publisher: John Wiley & Sons
ISBN: 3527334742
Category : Science
Languages : en
Pages : 884
Book Description
The only comprehensive reference on this popular and rapidly developing technique provides a detailed overview, ranging from fundamentals to applications, including a section on the evaluation of GC-MS analyses. As such, it covers all aspects, including the theory and principles, as well as a broad range of real-life examples taken from laboratories in environmental, food, pharmaceutical and clinical analysis. It also features a glossary of approximately 300 terms and a substance index that facilitates finding a specific application. The first two editions were very well received, making this handbook a must-have in all analytical laboratories using GC-MS.
Handbook of Analytical Quality by Design
Author: Sarwar Beg
Publisher: Academic Press
ISBN: 0128203331
Category : Science
Languages : en
Pages : 225
Book Description
Handbook of Analytical Quality by Design addresses the steps involved in analytical method development and validation in an effort to avoid quality crises in later stages. The AQbD approach significantly enhances method performance and robustness which are crucial during inter-laboratory studies and also affect the analytical lifecycle of the developed method. Sections cover sample preparation problems and the usefulness of the QbD concept involving Quality Risk Management (QRM), Design of Experiments (DoE) and Multivariate (MVT) Statistical Approaches to solve by optimizing the developed method, along with validation for different techniques like HPLC, UPLC, UFLC, LC-MS and electrophoresis. This will be an ideal resource for graduate students and professionals working in the pharmaceutical industry, analytical chemistry, regulatory agencies, and those in related academic fields. - Concise language for easy understanding of the novel and holistic concept - Covers key aspects of analytical development and validation - Provides a robust, flexible, operable range for an analytical method with greater excellence and regulatory compliance
Publisher: Academic Press
ISBN: 0128203331
Category : Science
Languages : en
Pages : 225
Book Description
Handbook of Analytical Quality by Design addresses the steps involved in analytical method development and validation in an effort to avoid quality crises in later stages. The AQbD approach significantly enhances method performance and robustness which are crucial during inter-laboratory studies and also affect the analytical lifecycle of the developed method. Sections cover sample preparation problems and the usefulness of the QbD concept involving Quality Risk Management (QRM), Design of Experiments (DoE) and Multivariate (MVT) Statistical Approaches to solve by optimizing the developed method, along with validation for different techniques like HPLC, UPLC, UFLC, LC-MS and electrophoresis. This will be an ideal resource for graduate students and professionals working in the pharmaceutical industry, analytical chemistry, regulatory agencies, and those in related academic fields. - Concise language for easy understanding of the novel and holistic concept - Covers key aspects of analytical development and validation - Provides a robust, flexible, operable range for an analytical method with greater excellence and regulatory compliance