Pharmaceutical and Medical Applications of Near-Infrared Spectroscopy, Second Edition

180 Pages·2014·3.59 MB·English

by  Emil W. Ciurczak

Spectroscopy C
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SECOND EDITION I
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Pharmaceutical and Medical Applications N
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of Near-Infrared Spectroscopy
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Since the completion of the first edition of this book, major developments M
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have occurred in the pharmaceutical industry that have shaped the field of C
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near-infrared (NIR) spectroscopy. A new initiative from the U.S. Food and Drug U
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Administration (FDA) to modernize regulations of pharmaceutical manufacturing IC
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and drug quality has helped position NIR spectroscopy as an effective tool for L A
pharmaceutical testing. Pharmaceutical and Medical Applications of N
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Near-Infrared Spectroscopy: Second Edition reflects these developments M
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and brings readers an up-to-date summary of how this technique is being D
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applied to pharmaceutical manufacturing. A
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Topics include P
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• The origins and principles of NIR spectroscopy, including early instrumenta- IC
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tion, spectroscopic theory, and light–particle interaction TIO S E C O N D E D I T I O N
• The physics of each instrument type, the strengths and weaknesses of each, N
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and the manufacturers that produce them O Pharmaceutical
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• The possible advantages of using NIR methods for monitoring or controlling N and
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blending, as well as practical concerns for mixing processes A
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• NIR spectroscopy as applied to traditional granulation, drug layering, and film -IN
coating of beads or granules F
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A Medical Applications
• Pharmaceutical assays, including qualitative analysis, quantitative analysis, R
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determination of actives in tablets and capsules, and considerations for D
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intact dosage form analysis P
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• Steps involved in the validation and acceptance of an NIR spectroscopy C
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method, including quality assurance, qualification and verification of instru- R
O Near-Infrared
ments, and the International Conference on Harmonization (ICH) guidelines SC of
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• Medical applications, including those related to blood glucose measure- P
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ments, tissue and major organ analysis, fetal analysis, and cancer research
Providing comprehensive coverage of NIR spectroscopy, from theory, mathe- S Spectroscopy
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matics, application, and mechanics of NIR analysis, the book supplies ample C
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references to facilitate further research into this burgeoning field. N
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84143
ISBN: 978-1-4200-8414-6 Emil W. Ciurczak • Benoît Igne
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9 781420 084146

S E C O N D E D I T I O N
Pharmaceutical
and
Medical Applications
Near-Infrared
of
Spectroscopy
PRACTICAL SPECTROSCOPY
A SERIES

1. Infrared and Raman Spectroscopy (in three parts),
edited by Edward G. Brame, Jr. and Jeanette G. Grasselli
2. X-Ray Spectrometry, edited by H. K. Herglotz and L. S. Birks
3. Mass Spectrometry (in two parts), edited by Charles Merritt, Jr.
and Charles N. McEwen
4. Infrared and Raman Spectroscopy of Polymers, H. W. Siesler
and K. Holland-Moritz
5. NMR Spectroscopy Techniques, edited by Cecil Dybowski and
Robert L. Lichter
6. Infrared Microspectroscopy: Theory and Applications,
edited by Robert G. Messer schmidt and Matthew A. Harthcock
7. Flow Injection Atomic Spectroscopy, edited by Jose Luis Burguera
8. Mass Spectrometry of Biological Materials, edited by Charles N. McEwen
and Barbara S. Larsen
9. Field Desorption Mass Spectrometry, László Prókai
10. Chromatography/Fourier Transform Infrared Spectroscopy and
Its Applications, Robert White
11. Modern NMR Techniques and Their Application in Chemistry,
edited by Alexander I. Popov and Klaas Hallenga
12. Luminescence Techniques in Chemical and Biochemical Analysis,
edited by Willy R. G. Baeyens, Denis De Keukeleire, and Katherine Korkidis
13. Handbook of Near-Infrared Analysis, edited by Donald A. Burns
and Emil W. Ciurczak
14. Handbook of X-Ray Spectrometry: Methods and Techniques,
edited by René E. Van Grieken and Andrzej A. Markowicz
15. Internal Reflection Spectroscopy: Theory and Applications,
edited by Francis M. Mirabella, Jr.
16. Microscopic and Spectroscopic Imaging of the Chemical State,
edited by Michael D. Morris
17. Mathematical Analysis of Spectral Orthogonality, John H. Kalivas
and Patrick M. Lang
18. Laser Spectroscopy: Techniques and Applications, E. Roland Menzel
19. Practical Guide to Infrared Microspectroscopy,
edited by Howard J. Humecki
20. Quantitative X-ray Spectrometry: Second Edition,
Ron Jenkins, R. W. Gould, and Dale Gedcke
21. NMR Spectroscopy Techniques: Second Edition, Revised and Expanded,
edited by Martha D. Bruch
22. Spectrophotometric Reactions, Irena Nemcova, Ludmila Cermakova,
and Jiri Gasparic
23. Inorganic Mass Spectrometry: Fundamentals and Applications, edited by
Christopher M. Barshick, Douglas C. Duckworth, and David H. Smith
24. Infrared and Raman Spectroscopy of Biological Materials,
edited by Hans-Ulrich Gremlich and Bing Yan
25. Near-Infrared Applications In Biotechnology,
edited by Ramesh Raghav achari
26. Ultrafast Infrared and Ramen Spectroscopy, edited by M. D. Fayer
27. Handbook of Near-Infrared Analysis: Second Edition, Revised
and Expand ed, edited by Donald A. Burns and Emil W. Ciurczak
28. Handbook of Raman Spectroscopy: From the Research Laboratory to the
Process Line, edited by Ian R. Lewis and Howell G. M. Edwards
29. Handbook of X-Ray Spectrometry: Second Edition, Revised and Expanded,
edited by René E. Van Grieken and Andrzej A. Markowicz
30. Ultraviolet Spectroscopy and UV Lasers, edited by Prabhakar Misra
and Mark A. Dubinskii
31. Pharmaceutical and Medical Applications of Near-Infrared Spectroscopy,
Emil W. Ciurczak and James K. Drennen III
32. Applied Electrospray Mass Spectrometry, edited by Birendra N. Pra ma nik,
A. K. Ganguly, and Michael L. Gross
33. Practical Guide to ICP-MS, edited by Robert Thomas
34. NMR Spectroscopy of Biological Solids, edited by A. Ramamoorthy
35. Handbook of Near Infrared Analysis, Third Edition,
edited by Donald A. Burns and Emil W. Ciurczak
36. Coherent Vibrational Dynamics, edited by Guglielmo Lanzani,
Giulio Cerullo, and Sandro De Silvestri
37. Practical Guide to ICP-MS: A Tutorial for Beginners, Second Edition,
Robert Thomas
38. Practical Guide to ICP-MS: A Tutorial for Beginners, Third Edition,
Robert Thomas
39. Pharmaceutical and Medical Applications of Near-Infrared Spectroscopy,
Emil W. Ciurczak and Benoit Igne

S E C O N D E D I T I O N
Pharmaceutical
and
Medical Applications
Near-Infrared
of
Spectroscopy
Emil W. Ciurczak • Benoît Igne
Boca Raton London New York
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To my wife, Courtney, and children, for their love and
support, and to all the researchers that have advanced
near-infrared spectroscopy.
Benoît Igne
To my wife, Alissa, my wonderful son and daughter
(Alex and Alyssa), and my special grandsons, Charlie, Kyle,
and Ethan, for being my family support system.
Emil W. Ciurczak