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Guidance for industry [[electronic resource] ] : ANDAs, pharmaceutical solid polymorphism, chemistry, manufacturing and controls information
| Guidance for industry [[electronic resource] ] : ANDAs, pharmaceutical solid polymorphism, chemistry, manufacturing and controls information |
| Pubbl/distr/stampa | Rockville, MD : , : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, , [2007] |
| Descrizione fisica | 1 online resource (10 pages) : charts |
| Soggetto topico |
Polymorphism (Crystallography)
Drug factories - Government policy - United States Drug stability - Government policy - United States |
| Formato | Materiale a stampa  |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Altri titoli varianti | Guidance for industry |
| Record Nr. | UNINA-9910699281803321 |
| Rockville, MD : , : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, , [2007] | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
Liquid Polymorphism : Advances in Chemical Physics . Volume 152
| Liquid Polymorphism : Advances in Chemical Physics . Volume 152 |
| Autore | Stanley H. E |
| Pubbl/distr/stampa | Hoboken, : Wiley, 2013 |
| Descrizione fisica | 1 online resource (654 p.) |
| Disciplina |
541.2
541.3 |
| Collana | Advances in Chemical Physics, v. 152 |
| Soggetto topico |
Chemistry, Physical and theoretical
Electron Spectroscopy Polymorphism (Crystallography) Liquids Chemical & Materials Engineering Engineering & Applied Sciences Materials Science |
| ISBN |
1-118-54037-9
1-118-54035-2 1-299-44917-4 1-118-54036-0 |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Nota di contenuto |
Liquid Polymorphism: Advances In Chemical Physics; CONTRIBUTORS TO VOLUME 152; FOREWORD; PREFACE; PREFACE TO THE SERIES; CONTENTS; Electron Spin Resonance Studies of Supercooled Water; I. Introduction; II. Outline of ESR Spectroscopy; A. Spin Probes; B. Rigid-Limit and Motional Narrowing of the Lineshape; C. Accessible Range of the Rotational Dynamics; III. ESR Spectroscopy of Spin Probes: Basic Theoretical Introduction; A. Spin Hamiltonian; B. Lineshape Analysis; 1. No Tumbling: Powder Lineshape; 2. Tumbling: Motional Narrowing of the ESR Lineshape
IV. ESR Studies of Liquid Water and Aqueous Solutions: A ReviewV. ESR Studies of Confined Water in Polycrystalline Ice; A. Water Confinement in Polycrystalline Ice; B. Location of Paramagnetic Solutes in Water-Ice Mixtures; C. Rotational Dynamics of TEMPOL in Interstitial Water of Polycrystalline Ice; 1. Spin Probe Mobility Above 130K; 2. Dynamical Heterogeneities; 3. Temperature Dependence of the Spin Probe Reorientation; 4. Breakdown of the Debye-Stokes-Einstein Law; 5. Spin Probe Sensing of the Water Static Heterogeneities; 6. Missing Evidence of Additional Impurities in Interstitial Water VI. SummaryReferences; Pressure-Driven Liquid-Liquid Transformations and Corresponding Bizarre Viscosity Behavior; I. Introduction; II. Methods; III. Results and Discussions; A. Se; B. AsS; C. As2S3; D. B2O3; IV. Conclusions; References; The Stability Limit and Other Open Questions on Water at Negative Pressure; I. Introduction; II. What is Negative Pressure?; III. The Phase Diagram of Water; IV. Experimental Methods to Generate Tension; A. Acoustic Cavitation; B. Metastable Vapor-Liquid Equilibrium; C. Berthelot Tube; D. Centrifuge Method; V. Limit(s) of Metastability A. Comparison Between the Different MethodsB. Origin of the Discrepancy in the Limits of Metastability; C. Remaining Issues with Inclusions; D. Path-Dependent Nucleation; VI. Other Topics in the Study of Liquids Under Tension; A. Equation of State of Water at Negative Pressure; B. Other Properties of Liquid at Negative Pressure; VII. Perspectives; References; Water-Like Anomalies of Core-Softened Fluids: Dependenceon the Trajectories in (PρT ) Space; I. Introduction; II. System and Methods; III. Results and Discussion; A. Diffusion Anomaly; B. Density Anomaly; C. Structural Anomaly IV. Rosenfeld ScalingV. Conclusions; References; High-Frequency Dynamics of Liquids Through a Liquid-Liquid Transition: The Case of CS; I. Introduction; II. The Case of Liquid Cesium; III. The Experiment; IV. Results; V. Discussion; VI. Conclusions; References; The Liquid-Liquid Phase Transition, Anomalous Properties, and Glass Behavior of Polymorphic Liquids; I. Introduction; II. Polymorphic Liquids: Phase Diagram, Anomalous Properties, and Glass Behavior; A. Liquid-Liquid Phase Transition; B. Supercritical Region: Anomalous Properties; C. Glass Polymorphism III. Computer Simulation Models of Polymorphic Liquids |
| Record Nr. | UNINA-9910139027103321 |
Stanley H. E
|
||
| Hoboken, : Wiley, 2013 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
Liquid Polymorphism : Advances in Chemical Physics . Volume 152
| Liquid Polymorphism : Advances in Chemical Physics . Volume 152 |
| Autore | Stanley H. E |
| Edizione | [1st ed.] |
| Pubbl/distr/stampa | Hoboken, : Wiley, 2013 |
| Descrizione fisica | 1 online resource (654 p.) |
| Disciplina |
541.2
541.3 |
| Collana | Advances in Chemical Physics, v. 152 |
| Soggetto topico |
Chemistry, Physical and theoretical
Electron Spectroscopy Polymorphism (Crystallography) Liquids Chemical & Materials Engineering Engineering & Applied Sciences Materials Science |
| ISBN |
9781118540374
1118540379 9781118540350 1118540352 9781299449176 1299449174 9781118540367 1118540360 |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Nota di contenuto |
Liquid Polymorphism: Advances In Chemical Physics; CONTRIBUTORS TO VOLUME 152; FOREWORD; PREFACE; PREFACE TO THE SERIES; CONTENTS; Electron Spin Resonance Studies of Supercooled Water; I. Introduction; II. Outline of ESR Spectroscopy; A. Spin Probes; B. Rigid-Limit and Motional Narrowing of the Lineshape; C. Accessible Range of the Rotational Dynamics; III. ESR Spectroscopy of Spin Probes: Basic Theoretical Introduction; A. Spin Hamiltonian; B. Lineshape Analysis; 1. No Tumbling: Powder Lineshape; 2. Tumbling: Motional Narrowing of the ESR Lineshape
IV. ESR Studies of Liquid Water and Aqueous Solutions: A ReviewV. ESR Studies of Confined Water in Polycrystalline Ice; A. Water Confinement in Polycrystalline Ice; B. Location of Paramagnetic Solutes in Water-Ice Mixtures; C. Rotational Dynamics of TEMPOL in Interstitial Water of Polycrystalline Ice; 1. Spin Probe Mobility Above 130K; 2. Dynamical Heterogeneities; 3. Temperature Dependence of the Spin Probe Reorientation; 4. Breakdown of the Debye-Stokes-Einstein Law; 5. Spin Probe Sensing of the Water Static Heterogeneities; 6. Missing Evidence of Additional Impurities in Interstitial Water VI. SummaryReferences; Pressure-Driven Liquid-Liquid Transformations and Corresponding Bizarre Viscosity Behavior; I. Introduction; II. Methods; III. Results and Discussions; A. Se; B. AsS; C. As2S3; D. B2O3; IV. Conclusions; References; The Stability Limit and Other Open Questions on Water at Negative Pressure; I. Introduction; II. What is Negative Pressure?; III. The Phase Diagram of Water; IV. Experimental Methods to Generate Tension; A. Acoustic Cavitation; B. Metastable Vapor-Liquid Equilibrium; C. Berthelot Tube; D. Centrifuge Method; V. Limit(s) of Metastability A. Comparison Between the Different MethodsB. Origin of the Discrepancy in the Limits of Metastability; C. Remaining Issues with Inclusions; D. Path-Dependent Nucleation; VI. Other Topics in the Study of Liquids Under Tension; A. Equation of State of Water at Negative Pressure; B. Other Properties of Liquid at Negative Pressure; VII. Perspectives; References; Water-Like Anomalies of Core-Softened Fluids: Dependenceon the Trajectories in (PρT ) Space; I. Introduction; II. System and Methods; III. Results and Discussion; A. Diffusion Anomaly; B. Density Anomaly; C. Structural Anomaly IV. Rosenfeld ScalingV. Conclusions; References; High-Frequency Dynamics of Liquids Through a Liquid-Liquid Transition: The Case of CS; I. Introduction; II. The Case of Liquid Cesium; III. The Experiment; IV. Results; V. Discussion; VI. Conclusions; References; The Liquid-Liquid Phase Transition, Anomalous Properties, and Glass Behavior of Polymorphic Liquids; I. Introduction; II. Polymorphic Liquids: Phase Diagram, Anomalous Properties, and Glass Behavior; A. Liquid-Liquid Phase Transition; B. Supercritical Region: Anomalous Properties; C. Glass Polymorphism III. Computer Simulation Models of Polymorphic Liquids |
| Record Nr. | UNINA-9910818054503321 |
|
Stanley H. E
|
||
| Hoboken, : Wiley, 2013 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
Polymorphism in molecular crystals [[electronic resource] /] / Joel Bernstein
| Polymorphism in molecular crystals [[electronic resource] /] / Joel Bernstein |
| Autore | Bernstein Joel <1941-2019.> |
| Pubbl/distr/stampa | Oxford, : Clarendon Press |
| Descrizione fisica | 1 online resource (429 p.) |
| Disciplina | 548/.3 |
| Collana | International Union of Crystallography monographs on crystallography |
| Soggetto topico |
Polymorphism (Crystallography)
Molecular crystals |
| Soggetto genere / forma | Electronic books. |
| ISBN |
1-281-34127-4
0-19-154501-5 9786611341275 0-19-923656-9 |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Nota di contenuto |
Contents; 1 Introduction and historical background; 1.1 Introduction; 1.2 Definitions; 1.2.1 Polymorphism; 1.2.2 Pseudopolymorphism, solvates, and hydrates; 1.2.3 Conventions for naming polymorphs; 1.3 Is this material polymorphic?; 1.3.1 Occurrence of polymorphism; 1.3.2 Literature sources of polymorphic compounds; 1.3.3 Polymorphic compounds in the Cambridge Structural Database; 1.3.4 Powder Diffraction File; 1.3.5 Patent literature; 1.3.6 Polymorphism of elements and inorganic compounds; 1.3.7 Polymorphism in macromolecular crystals; 1.4 Historical perspective
1.5 Commercial/industrial importance of polymorphism-some additional comments2 Fundamentals; 2.1 Introduction; 2.2 Thermodynamics of polymorphic molecular crystals; 2.2.1 The Phase Rule; 2.2.2 Thermodynamic relations in polymorphs; 2.2.3 Energy vs temperature diagrams-the Gibbs free energy; 2.2.4 Enantiotropism and monotropism; 2.2.5 Phase diagrams in terms of pressure and temperature; 2.2.6 Heat-of-transition rule; 2.2.7 Heat-of-fusion rule; 2.2.8 Entropy-of-fusion rule; 2.2.9 Heat-capacity rule; 2.2.10 Density rule; 2.2.11 Infrared rule 2.3 Kinetic factors determining the formation of polymorphic modifications2.4 Structural fundamentals; 2.4.1 Form vs habit; 2.4.2 Structural characterization and comparison of polymorphic systems; 2.4.3 Presentation of polymorphic structures for comparison; 3 Controlling the polymorphic form obtained; 3.1 General considerations; 3.2 Aggregation and nucleation; 3.3 Thermodynamic vs kinetic crystallization conditions; 3.4 Monotropism, enantiotropism, and crystallization strategy; 3.5 Concomitant polymorphs; 3.5.1 Crystallization methods and conditions 3.5.2 Examples of different classes of compounds3.5.3 The structural approach; 3.6 Disappearing polymorphs; 3.7 Control of polymorphic crystallization by design; 4 Analytical techniques for studying and characterizing polymorphs; 4.1 Introduction; 4.2 Optical/hot stage microscopy; 4.3 Thermal methods; 4.4 X-ray crystallography; 4.5 Infrared spectroscopy; 4.6 Raman spectroscopy; 4.7 Solid state nuclear magnetic resonance (SSNMR) spectroscopy; 4.8 Scanning electron microscopy; 4.9 Atomic force microscopy (AFM) and scanning tunnelling microscopy (STM); 4.10 Density measurements 4.11 New technologies and 'hyphenated techniques'4.12 Are two samples polymorphs of the same compound?; 4.13 Concluding remarks; 5 Conformational polymorphism: intra- and intermolecular energetics; 5.1 Introduction; 5.2 Molecular shape and energetics; 5.3 Intermolecular interactions and energetics; 5.4 The search for examples of conformational polymorphism; 5.5 Presenting and comparing conformational polymorphs; 5.6 Some examples of conformational polymorphism; 5.7 What are conformational polymorphs good for?; 5.8 Computational studies of the energetics of polymorphic systems 5.9 Some exemplary studies of conformational polymorphism |
| Record Nr. | UNINA-9910465109503321 |
|
Bernstein Joel <1941-2019.>
|
||
| Oxford, : Clarendon Press | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
Polymorphism in molecular crystals [[electronic resource] /] / Joel Bernstein
| Polymorphism in molecular crystals [[electronic resource] /] / Joel Bernstein |
| Autore | Bernstein Joel <1941-2019.> |
| Pubbl/distr/stampa | Oxford, : Clarendon Press |
| Descrizione fisica | 1 online resource (429 p.) |
| Disciplina | 548/.3 |
| Collana | International Union of Crystallography monographs on crystallography |
| Soggetto topico |
Polymorphism (Crystallography)
Molecular crystals |
| ISBN |
1-281-34127-4
0-19-154501-5 9786611341275 0-19-923656-9 |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Nota di contenuto |
Contents; 1 Introduction and historical background; 1.1 Introduction; 1.2 Definitions; 1.2.1 Polymorphism; 1.2.2 Pseudopolymorphism, solvates, and hydrates; 1.2.3 Conventions for naming polymorphs; 1.3 Is this material polymorphic?; 1.3.1 Occurrence of polymorphism; 1.3.2 Literature sources of polymorphic compounds; 1.3.3 Polymorphic compounds in the Cambridge Structural Database; 1.3.4 Powder Diffraction File; 1.3.5 Patent literature; 1.3.6 Polymorphism of elements and inorganic compounds; 1.3.7 Polymorphism in macromolecular crystals; 1.4 Historical perspective
1.5 Commercial/industrial importance of polymorphism-some additional comments2 Fundamentals; 2.1 Introduction; 2.2 Thermodynamics of polymorphic molecular crystals; 2.2.1 The Phase Rule; 2.2.2 Thermodynamic relations in polymorphs; 2.2.3 Energy vs temperature diagrams-the Gibbs free energy; 2.2.4 Enantiotropism and monotropism; 2.2.5 Phase diagrams in terms of pressure and temperature; 2.2.6 Heat-of-transition rule; 2.2.7 Heat-of-fusion rule; 2.2.8 Entropy-of-fusion rule; 2.2.9 Heat-capacity rule; 2.2.10 Density rule; 2.2.11 Infrared rule 2.3 Kinetic factors determining the formation of polymorphic modifications2.4 Structural fundamentals; 2.4.1 Form vs habit; 2.4.2 Structural characterization and comparison of polymorphic systems; 2.4.3 Presentation of polymorphic structures for comparison; 3 Controlling the polymorphic form obtained; 3.1 General considerations; 3.2 Aggregation and nucleation; 3.3 Thermodynamic vs kinetic crystallization conditions; 3.4 Monotropism, enantiotropism, and crystallization strategy; 3.5 Concomitant polymorphs; 3.5.1 Crystallization methods and conditions 3.5.2 Examples of different classes of compounds3.5.3 The structural approach; 3.6 Disappearing polymorphs; 3.7 Control of polymorphic crystallization by design; 4 Analytical techniques for studying and characterizing polymorphs; 4.1 Introduction; 4.2 Optical/hot stage microscopy; 4.3 Thermal methods; 4.4 X-ray crystallography; 4.5 Infrared spectroscopy; 4.6 Raman spectroscopy; 4.7 Solid state nuclear magnetic resonance (SSNMR) spectroscopy; 4.8 Scanning electron microscopy; 4.9 Atomic force microscopy (AFM) and scanning tunnelling microscopy (STM); 4.10 Density measurements 4.11 New technologies and 'hyphenated techniques'4.12 Are two samples polymorphs of the same compound?; 4.13 Concluding remarks; 5 Conformational polymorphism: intra- and intermolecular energetics; 5.1 Introduction; 5.2 Molecular shape and energetics; 5.3 Intermolecular interactions and energetics; 5.4 The search for examples of conformational polymorphism; 5.5 Presenting and comparing conformational polymorphs; 5.6 Some examples of conformational polymorphism; 5.7 What are conformational polymorphs good for?; 5.8 Computational studies of the energetics of polymorphic systems 5.9 Some exemplary studies of conformational polymorphism |
| Record Nr. | UNINA-9910792255003321 |
|
Bernstein Joel <1941-2019.>
|
||
| Oxford, : Clarendon Press | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
Polymorphism in molecular crystals / / Joel Bernstein
| Polymorphism in molecular crystals / / Joel Bernstein |
| Autore | Bernstein Joel <1941-> |
| Edizione | [1st ed.] |
| Pubbl/distr/stampa | Oxford, : Clarendon Press |
| Descrizione fisica | 1 online resource (429 p.) |
| Disciplina | 548/.3 |
| Collana | International Union of Crystallography monographs on crystallography |
| Soggetto topico |
Polymorphism (Crystallography)
Molecular crystals |
| ISBN |
1-281-34127-4
0-19-154501-5 9786611341275 0-19-923656-9 |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Nota di contenuto |
Contents; 1 Introduction and historical background; 1.1 Introduction; 1.2 Definitions; 1.2.1 Polymorphism; 1.2.2 Pseudopolymorphism, solvates, and hydrates; 1.2.3 Conventions for naming polymorphs; 1.3 Is this material polymorphic?; 1.3.1 Occurrence of polymorphism; 1.3.2 Literature sources of polymorphic compounds; 1.3.3 Polymorphic compounds in the Cambridge Structural Database; 1.3.4 Powder Diffraction File; 1.3.5 Patent literature; 1.3.6 Polymorphism of elements and inorganic compounds; 1.3.7 Polymorphism in macromolecular crystals; 1.4 Historical perspective
1.5 Commercial/industrial importance of polymorphism-some additional comments2 Fundamentals; 2.1 Introduction; 2.2 Thermodynamics of polymorphic molecular crystals; 2.2.1 The Phase Rule; 2.2.2 Thermodynamic relations in polymorphs; 2.2.3 Energy vs temperature diagrams-the Gibbs free energy; 2.2.4 Enantiotropism and monotropism; 2.2.5 Phase diagrams in terms of pressure and temperature; 2.2.6 Heat-of-transition rule; 2.2.7 Heat-of-fusion rule; 2.2.8 Entropy-of-fusion rule; 2.2.9 Heat-capacity rule; 2.2.10 Density rule; 2.2.11 Infrared rule 2.3 Kinetic factors determining the formation of polymorphic modifications2.4 Structural fundamentals; 2.4.1 Form vs habit; 2.4.2 Structural characterization and comparison of polymorphic systems; 2.4.3 Presentation of polymorphic structures for comparison; 3 Controlling the polymorphic form obtained; 3.1 General considerations; 3.2 Aggregation and nucleation; 3.3 Thermodynamic vs kinetic crystallization conditions; 3.4 Monotropism, enantiotropism, and crystallization strategy; 3.5 Concomitant polymorphs; 3.5.1 Crystallization methods and conditions 3.5.2 Examples of different classes of compounds3.5.3 The structural approach; 3.6 Disappearing polymorphs; 3.7 Control of polymorphic crystallization by design; 4 Analytical techniques for studying and characterizing polymorphs; 4.1 Introduction; 4.2 Optical/hot stage microscopy; 4.3 Thermal methods; 4.4 X-ray crystallography; 4.5 Infrared spectroscopy; 4.6 Raman spectroscopy; 4.7 Solid state nuclear magnetic resonance (SSNMR) spectroscopy; 4.8 Scanning electron microscopy; 4.9 Atomic force microscopy (AFM) and scanning tunnelling microscopy (STM); 4.10 Density measurements 4.11 New technologies and 'hyphenated techniques'4.12 Are two samples polymorphs of the same compound?; 4.13 Concluding remarks; 5 Conformational polymorphism: intra- and intermolecular energetics; 5.1 Introduction; 5.2 Molecular shape and energetics; 5.3 Intermolecular interactions and energetics; 5.4 The search for examples of conformational polymorphism; 5.5 Presenting and comparing conformational polymorphs; 5.6 Some examples of conformational polymorphism; 5.7 What are conformational polymorphs good for?; 5.8 Computational studies of the energetics of polymorphic systems 5.9 Some exemplary studies of conformational polymorphism |
| Record Nr. | UNINA-9910953890103321 |
|
Bernstein Joel <1941->
|
||
| Oxford, : Clarendon Press | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
