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E-grāmata: Handbook of Isolation and Characterization of Impurities in Pharmaceuticals

(Pfizer Global R&D, Connecticut, USA), (President, Ahuja Consulting for Water Quality, Calabash, NC, USA)
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Handbook of Isolation and Characterization of Impurities in PharmaceuticalsPalielināt
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The United States Food and Drug Administration (FDA) and other regulatory bodies around the world require that impurities in drug substance and drug product levels recommended by the International Conference on Harmonisation (ICH) be isolated and characterized.

Identifying process-related impurities and degradation products also helps us to understand the production of impurities and assists in defining degradation mechanisms. When this process is performed at an early stage, there is ample time to address various aspects of drug development to prevent or control the production of impurities and degradation products well before the regulatory filing and thus assure production of a high-quality drug product.

This book, therefore, has been designed to meet the need for a reference text on the complex process of isolation and characterization of process-related (synthesis and formulation) impurities and degradation products to meet critical requlatory requirements.

It's objective is to provide guidance on isolating and characterizing impurities of pharmaceuticals such as drug candidates, drug substances, and drug products. The book outlines impurity identification processes and will be a key resource document for impurity analysis, isolation/synthesis, and characterization.

- Provides valuable information on isolation and characterization of impurities.
- Gives a regulatory perspective on the subject.
- Describes various considerations involved in meeting regulatory requirements.
- Discusses various sources of impurities and degredation products.
PREFACE xi
CONTRIBUTORS xv
1. Overview: Isolation and Characterization of Impurities
SATINDER AHUJA
I. Introduction
1(3)
II. Designations of Impurities
4(3)
III. Regulatory Requirements
7(1)
IV. Sources of Impurities
8(6)
V. Analytical Method Development
14(4)
VI. Isolation Methods
18(2)
VII. Characterization Methods
20(2)
VIII. Case Studies
22(2)
IX. Summary
24(1)
References
24(3)
2. Review of Regulatory Guidance on Impurities
RADHIKA RAJAGOPALAN
I. Introduction
27(1)
II. Types of Impurities-Drug Substance
28(2)
III. Role of Compendia
30(1)
IV. Role of Drug Master Files (DMF)-Type II and Impurities Evaluation
31(1)
V. Reference Standards for the Quantitation of Impurities and Analytical Procedures
32(1)
VI. Qualification of Impurities and New Impurities
32(1)
VII. Impurities in Drug Products
33(1)
VIII. Analytical Methodology for Impurities in Drug Product
33(3)
IX. Impurities Quantitation Post-Approval
36(1)
X. Role of Sponsors
36(1)
XI. Summary
36(1)
References
37(2)
3. Polymorphic and Solvatomorphic Impurities
HARRY G. BRITTAIN AND ALES MEDEK
I. Introduction
39(1)
II. X-ray Diffraction
40(4)
III. Thermal Methods of Analysis
44(5)
IV. Vibrational Spectroscopy
49(8)
V. Solid-State Nuclear Magnetic Resonance Spectrometry
57(12)
References
69(6)
4. Impurities in Drug Products
KENNETH C. WATERMAN, ROGER C. ADAMI, AND JINYANG HONG
I. Introduction
75(1)
II. Water
76(2)
III. Peroxides
78(1)
IV. Aldehydes
79(1)
V. Metal impurities
80(2)
VI. Small Molecule Carboxylic Acids
82(1)
VII. Leachables/Extractables
82(1)
VIII. Alcohols as Impurities
83(1)
IX. Biological Impurities
83(1)
X. Additives in Excipients
84(1)
XI. Final Observations
85(1)
XII. Summary
85(1)
References
85(4)
5. Strategies for Investigation and Control of Process- and Degradation-Related Impurities
BERNARD A. OLSEN AND STEVEN W. BAERTSCHI
I. Introduction
89(2)
II. Goals and Strategies
91(4)
III. Process-Related Impurities
95(7)
IV. Degradation-Related Impurities
102(13)
V. Summary and Conclusions
115(1)
References
116(3)
6. Reference Standards
PAUL A. CULBERTAND BRUCE D. JOHNSON
I. Introduction
119(1)
II. Definitions
120(1)
III. Life Cycle
121(4)
IV. Governance
125(2)
V. Qualification Process
127(12)
VI. Summary
139(1)
References
139(6)
7. Sample Selection for Analytical Method Development
HUGH J. CLARKS AND KENNETH J. NORRIS
I. Introduction
145(2)
II. Components of the Key Predictive Sample Set (KPSS)
147(1)
III. Stereoisomers
147(3)
IV. Matrix Components
150(1)
V. Process-Related Impurities (PRIS)
150(2)
VI. Purposeful Degradation Samples
152(3)
VII. Stability Samples
155(1)
VIII. Phase-Solubility Analysis
156(3)
IX. Sample Selection Strategies
159(3)
X. Summary
162(1)
Glossary
162(1)
References
163(3)
8. Sample Preparation Methods for the Analysis of Pharmaceutical Materials
DAVID T. ROSSI AND KENNETH G. MILLER
I. Introduction
166(1)
II. Solid-Phase Extraction (SPE)
166(8)
III. Liquid-Liquid Extraction (LLE)
174(7)
IV. Supercritical Fluid Extraction (SFE)
181(8)
V. Accelerated Solvent Extraction (ASE)
189(6)
VI. Centrifugation 194 VII. Filtration
195(4)
VIII. Summary
199(1)
References
199(4)
9. Isolation Methods I: Thin-Layer Chromatography
PAMELA M. GORMAN AND HONG JIANG
I. Introduction to Thin-Layer Chromatography (TLC)
203(3)
II. TLC Applications in Pharmaceutical Industry
206(1)
III. TLC Method Development and Validation
207(14)
IV. Impurity Isolation and Characterization by TLC
221(7)
References
228(3)
10. Isolation Methods II: Column Chromatography
MARK GUINN, RONALD BATES, BENJAMIN HRITZKO, TERI SHANKLIN, GLENN WILCOX, AND SAM GUHAN
I. Introduction
231(1)
II. Background
232(1)
III. Stationary Phases
233(4)
IV. Equipment
237(3)
V. Screening
240(4)
VI. Development of Preparative Method
244(2)
VII. Scaleup of Preparative Method
246(2)
Summary
248(1)
References
248(1)
11. Mass Spectral Characterization
DAVID J. BURINSKYAND FENG WANG
I. Introduction
249(3)
II. Relevance of Impurity Characterization
252(7)
III. The coupling of Liquid-Phase Separations and Mass Spectrometers
259(5)
IV. Ion Formation
264(9)
V. Analyzers
273(4)
VI. Ion Structure Interrogation
277(5)
VII. Data Acquisition and Interpretation
282(4)
VIII. Applications
286(2)
IX. Conclusions
288(1)
X. Summary
289(1)
References
290(11)
12. NMR Characterization of Impurities
LINDA L. LOHR, ANDREW J. JENSEN, ANDTHOMAS R. SHARP
I. Introduction to Nuclear Magnetic Resonance (NMR)
301(3)
II. Information Gathering
304(1)
III. Sample Preparation for NMR
305(2)
IV. Sample Preparation for LC-NMR
307(2)
V. NMR Instrumentation
309(5)
VI. NMR Experiments
314(10)
VII. Choosing an Experiment Set
324(1)
VIII. Data Interpretation
325(9)
IX. Final Steps
334(2)
X. Summary
336(1)
References
337(4)
13. Hyphenated Characterization Techniques
THOMAS N. FEINBERG
I. Introduction
341(9)
II. Experimental Examples
350(6)
III. Conclusions
356(1)
References
357(4)
14. Solving Impurity/Degradation Problems: Case Studies
KAREN M. ALSANTE, TODD D. HATAJIK, LINDA L. LOHR, DINOS SANTAFIANOS, ANDTHOMAS R. SHARP
I. Introduction and Background
361(7)
II. Case Studies
368(30)
III. Summary and Conclusions
398(1)
Appendix-Lessons Learned
398(1)
References
399(2)
Index 401


Satinder Ahuja is a leading expert on water quality improvement. He earned his PhD in analytical chemistry from the University of the Sciences in Philadelphia. He worked for Novartis Corp. in various leadership positions for over 25 years and taught as an adjunct professor at Pace University for over 10 years. As president of Ahuja Consulting, he advises on water quality issues relating to chemicals and pharmaceuticals. A member of the executive committee of the Rivers of the World Foundation (ROW), Dr. Ahuja has organized numerous global symposia on improving water quality, including presentations for the American Chemical Society and UNESCO. Dr. Ahuja has published numerous papers and more than 25 books. His latest books are Contaminants in Our Water (ACS, 2020); Evaluating Water Quality to Prevent Future Disasters (Elsevier, 2019); Advances in Water Purification Techniques (Elsevier, 2019); and Chemistry and Water (Elsevier, 2017). Dr. Karen Mills Alsante is a Senior Research Investigator in the Analytical Research & Development Department at Pfizer Groton Central Research. She worked as a Development Scientist in Groton Quality Operations for 3 years before moving to her current position in the Analytical Research & Development department in 1997. Over the past five years, Karen has established a Degredation Technology Group with the mission of gaining a better understanding of the chemical and physical stability of Pfizer drug substances and drug products at an earlier stage of the drug development process.
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