Analytical sciences discovery, development and manufacture of medicines use is extensive. , Min of complex bio-analytical quality control the final dosage form, analytical technology covers a huge range of techniques and procedures.
This book focuses on the analytical aspects of drug development and manufacturing, focusing on the active ingredient or drug substance analysis. The book is a detailed description of drug product analysis - usually drug substances and excipients and formulation. However, many of the methods described in the description of drugs, may be subject to a formula in accordance with accounting excipients presence of the analyte or to extract and analyze the active substance.
The pharmaceutical industry is one of the most active areas of application and development of new methods and analytical sciences. This volume gives you all join the industry or other areas of pharmaceutical research and reference in various technologies and their application to the source, allowing them to choose the most appropriate analytical method for a particular purpose.
No analysis of pharmaceutical substances should ignore important book in terms of quality and regulation. The first chapter up-to date overview of philosophy and practical work in a regulated environment, taking into account existing legislation and guidance.
The following sections cover the key areas of separation science and spectroscopy. RECOGNIZING the importance and breadth of separation sciences, the authors focus on our method of development of high-performance liquid chromatography (HPLC or LC), capillary electrophoresis (CE), gas chromatography (GC) and thin-layer chromatography (TLC), covering traditional methods and without the above calculation Chemometrics methods. One of the most important and complex area of pharmaceutical analysis and chiral purity determination. Therefore, it is necessary that the Division for this area. From the analysis with a chiral described, together with the methods of separation across the sciences and the development.
In considering Spectroscopy, development and widespread use of technology together form the majority of all chapters covering nuclear magnetic resonance (NMR) and mass spectrometry (MS) size. In addition to NMR Division, provided extensive coverage of state-of-the-art with LC / NMR. The Division also includes the multi-nuclear NMR, computer-aided spectral interpretation of quantitative NMR and solid-state NMR - all important methods used in pharmaceutical development laboratory.
In recent years, many important events in MS. This book will be appointed by our technical team, focusing on the various tool options, their underlying principles and their application to pharmaceutical analysis. Mass spectrometry applications, both the structure and interpretation of quantitative analysis are considered. Quantitative analysis of the MS subject in detail, the reader can gain knowledge about the background of the technique is becoming an important drug substance analysis. Vibrational spectrosopy use can support the structural interpretation by NMR and MS, but more generally it is used to test the identity, because IR and Raman spectra act as molecular structure fingerprints. However, both IR and Raman find its main application for polymorphism analysis. Examples are described in this section, together with the benefit of coupling these methods with microscopy.
Additional methods are hard coated on solid analysis and polymorphism section. Detection and control of solid-state form of both crystal structure and particle properties are important. Physical properties of drug substance will affect the behavior of handling and formulation processes, and can have a significant impact on dissolution, solubility, and bioavailability. Although the microscope and image used above, a separate section for the optical and electronic imaging and image analysis techniques, which play an increasingly important role in the analysis of contaminants in drug distribution and use of adjuvants.
In the final section deals with the increasingly important area of process analytical science. There is a growing interest in the production process measurements FDA and other regulatory authorities, which seems certain to be a rapidly growing field of analytical sciences for the pharmaceutical industry.
This book focuses on the analytical aspects of drug development and manufacturing, focusing on the active ingredient or drug substance analysis. The book is a detailed description of drug product analysis - usually drug substances and excipients and formulation. However, many of the methods described in the description of drugs, may be subject to a formula in accordance with accounting excipients presence of the analyte or to extract and analyze the active substance.
The pharmaceutical industry is one of the most active areas of application and development of new methods and analytical sciences. This volume gives you all join the industry or other areas of pharmaceutical research and reference in various technologies and their application to the source, allowing them to choose the most appropriate analytical method for a particular purpose.
No analysis of pharmaceutical substances should ignore important book in terms of quality and regulation. The first chapter up-to date overview of philosophy and practical work in a regulated environment, taking into account existing legislation and guidance.
The following sections cover the key areas of separation science and spectroscopy. RECOGNIZING the importance and breadth of separation sciences, the authors focus on our method of development of high-performance liquid chromatography (HPLC or LC), capillary electrophoresis (CE), gas chromatography (GC) and thin-layer chromatography (TLC), covering traditional methods and without the above calculation Chemometrics methods. One of the most important and complex area of pharmaceutical analysis and chiral purity determination. Therefore, it is necessary that the Division for this area. From the analysis with a chiral described, together with the methods of separation across the sciences and the development. In considering Spectroscopy, development and widespread use of technology together form the majority of all chapters covering nuclear magnetic resonance (NMR) and mass spectrometry (MS) size. In addition to NMR Division, provided extensive coverage of state-of-the-art with LC / NMR. The Division also includes the multi-nuclear NMR, computer-aided spectral interpretation of quantitative NMR and solid-state NMR - all important methods used in pharmaceutical development laboratory.
In recent years, many important events in MS. This book will be appointed by our technical team, focusing on the various tool options, their underlying principles and their application to pharmaceutical analysis. Mass spectrometry applications, both the structure and interpretation of quantitative analysis are considered. Quantitative analysis of the MS subject in detail, the reader can gain knowledge about the background of the technique is becoming an important drug substance analysis. Vibrational spectrosopy use can support the structural interpretation by NMR and MS, but more generally it is used to test the identity, because IR and Raman spectra act as molecular structure fingerprints. However, both IR and Raman find its main application for polymorphism analysis. Examples are described in this section, together with the benefit of coupling these methods with microscopy.
Additional methods are hard coated on solid analysis and polymorphism section. Detection and control of solid-state form of both crystal structure and particle properties are important. Physical properties of drug substance will affect the behavior of handling and formulation processes, and can have a significant impact on dissolution, solubility, and bioavailability. Although the microscope and image used above, a separate section for the optical and electronic imaging and image analysis techniques, which play an increasingly important role in the analysis of contaminants in drug distribution and use of adjuvants.
In the final section deals with the increasingly important area of process analytical science. There is a growing interest in the production process measurements FDA and other regulatory authorities, which seems certain to be a rapidly growing field of analytical sciences for the pharmaceutical industry.
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