Features

• Drug development process in the pharmaceutical industry
• Uniform and consistent interpretation of GMP compliance issues
• Reviews of the role of statistics and basic topics in analytical chemistry
• Emphasis on high-performance liquid chromatographic (HPLC) methods
• Chapters on detectors and quantitative analysis as well as data systems
• Methods for ensuring that instruments meet standard operating procedures (SOP) requirements
• Extensive appendixes for unifying terms, symbols, and procedural information

This practical reference provides guidance for laboratory analysts and other professionals who must work with both the Food and Drug Administration's good manufacturing practices (GMP) rules and rapidly changing analytical technologies.

Analytical Chemistry in a GMP Environment leads the reader through the concepts, techniques, and tools necessary to perform analyses in an FDA-regulated environment, including clear instructions on all major analytical chemical methods, from spectroscopy to chromatography to dissolution.

Contents

1. The Laboratory Analyst's Role in the Drug Development Process
   • Importance of Analytical Methodology in the Drug Development Process
   • Requirements of an Analytical Methodology During the Drug Development Process Release and Stability
   • Analyst Role in Formulations Development
   • Review of hte Analyst Role in Pharmacokinecics, Toxicology, and Clinical Support
   • Stability Program in the Pharmaceutical Industry
   
   
2. Laboratory Controls and Compliance
   • Laboratory Management
   • Laboratory Controls
   • Laboratory Compliance
   
   
3. USP, ICH, and Other Compendial Methods
   • USP/NF
   • European, British, Japanese Pharmacopeias
   • ICH Guideline
   
   
4. Statistics in the Pharmaceutical Analysis Laboratory
   • Errors Associated with Making Measurements
   • Significant Figures and Rounding
   • Definitions
   • Normal Distribution of Repeated Measurements
   • Student t Test
   • Propagation of Uncertainty
   • Rejection of Outliers
   • Linear Regression Analysis
   • Quality Assurance/Control
   
   
5. Basic Analytical Operations and Solution Chemistry
   • Analytical Reagents
   • Sampling
   • Chemical Equilibrium
   • Aqueous Solution Eqilibria
   • Reduction-Oxidation Equilibria
   • Karl Fischer Titration
   • Methods for Determining Water
   • Miscellaneous Techniques
   
   
6. Spectroscopy
   • Electromagnetic Spectrum
   • Wave-Particle Duality
   • Transitions and Energies
   • Ultraviolet/Visible Spectroscopy
   • Infared Spectroscopy
   • Beers Law and Quantitative Analysis
   • Instrumentation
   • Raman Spectroscopy
   • Near-IR (NIR) Spectroscopy
   • Optical and Spectroscopic Techniques
   
   
7. Chromatographic Principles
   • Definitions, Terms, and Symbols
   • Comparison of GC and LC
   • Two Important Fundamentals
   • Additional Terms
   
   
8. Gas Chromatography
   • Historical Notes
   • Advantages and Disadvantages
   • Classification of GC
   • Columns
   • Instrument Components
   • Temperature Considerations
   • Optimization and Method Development
   • Special Topics
   • Applications
   
   
9. Liquid Chromatography: Basic Overview
   • Importance of HPLC in the Pharmaceutical Industry
   • Column Methods
   • Planar Methods: TLC and PC
   • USP
   • Instrumentation for HPLC
   • Capillary Elctrophoresis
   
   
10. HPLC Column Parameters
    • Column Equivalency
    • Review of Chromatographic Parameters
    • Parameters Necessary for Eqivalent Columns
    • Column Efficiency
    • Putting It All Together--Selecting an Equivalent Column
    
    
11. Dissolution
    • History
    • Dissolution Basics
    • USP/NF Pharmacopeia General Chapter
    • Measurement of the Pharmaceutical Active
    • Analyst Checklist
    
    
12. Analytical Method Development for Assay and Impurity Determination in Drug Substances and Drug Products
    • Background
    • Specifications and Their Influence on Method Development
    • Method Development Life Cycle--Overview
    • Planning
    • Method Development--General Considerations
    • Documentation
    • Method Development--Experimental Considerations
    • Validation Activities
    • Analytical Method Transfer
    • Periodic Review
    • Reference Standards and Samples to Support Stability Indicating Method Development
    
    
13. Some Principles of Quantitative Analysis
    • Detector Classifications
    • Detector Characteristics
    • Methods of Quantitative Analysis
    • Additional Topics
    
    
14. Laboratory Data Systems
    • Data and Information Managment
    • Laboratory Information Management Systems (LIMS)
    • Chromatography Data Systems
    • Analog-to-Digital (A/D) Conversion
    • CDS Workflow
    
    
15. Qualification of Laboratory Instrumentation, Validation, and Transfer of Analytical Methods
    • Instrument Qualification
    • Instrument Qualification Process--Assembly of the Qualification Team
    • Qualification Protocol
    • IQ Protocol
    • Instrument Qualification Summary
    • Analytical Method Validation
    • Systematic Approach to Validation Experimentation

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