ANALYTICAL CHEMISTRY IN A GMP ENVIRONMENT
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1 ANALYTICAL CHEMISTRY IN A GMP ENVIRONMENT A Practical Guide EDITED BY James M. Miller Jonathan B. Crowther A WILEY-INTERSCIENCE PUBLICATION JOHN WILEY & SONS, INC. New York / Chichester / Weinheim / Brisbane / Singapore / Toronto
2 CONTENTS CONTRIBUTORS FOREWORD PREFACE xix xxi xxiii 1 The Laboratory Analyst's Role in the Drug Development Process 1 Jonathan B. Crowther, William Lauwers, Sagar Adusumalli, and Ponniah Shenbagamurthi 1.1. Introduction / The Importance of Analytical Methodology in the Drug Development Process / Interdiscipline Use of Analytical Methodology / Phases of Drug Development / Introductory Summary / Requirements of an Analytical Methodology During the Drug Development Process Release and Stability / Introduction / Discovery Phase / Early Development / Final Development (Phase III) / The Analyst Role in Formulations Development / Overview / Analytical Testing in Formulations Development / Pharmaceutical Excipients / Pharmaceutical Development Summary / 13
3 Vi CONTENTS 1.4. Review of the Analyst Role in Pharmacokinetics, Toxicology, and Clinical Support / Introduction / Bioanalytical Considerations / Preclinical Pharmacokinetics/ Pharmacodynamics / Preclinical Safety Studies / Mass Balance and Metabolism / Clinical Support / Stability Program in Pharmaceutical Industry / Introduction / Goals of the Stability Program / ICH Guidelines on Stability Testing of Drug Products / Stability Monitoring / Stability-Indicating Methods / Pharmaceutical Packaging and Stability / Stability Summary / Chapter Summary / 28 References / 29 2 Laboratory Controls and Compliance 31 Henry Avallone 2.1. Introduction / Laboratory Management / Management Responsibility / Training / Laboratory Controls / Laboratory Records / Out of Specification/Trend (OOS/OOT) / Laboratory Deviations/Nonconformances / Test Methods/Procedures/Specifications / Calibration and Maintenance / Laboratory Compliance / General Notices / Method Development / 43
4 CONTENTS Vii Conclusion / 47 References / 47 Method Validation / 44 Method Transfer / 46 Auditing the Laboratory / 46 Use of Outside Testing Laboratories / 47 3 The USP, ICH, and Other Compendial Methods 49 Jennifer G. Feldman 3.1. Introduction / USP/NF / Introduction / Organization/Overview / USP/NF and the FDA / FDA Requirements for Regulatory Submissions/Field Inspections / Analysis of Excipients/Raw Materials/Drug Substance/Drug Product / "Meets USP" Labeling / Methodology / Accept/Reject Criteria / Validation / European, British, Japanese Pharmacopeias / EP, Third Edition / BP / JP, Thirteenth Edition / ICH Guideline / Introduction/Role of the Guidelines / Summary of the Guidelines / Conclusion / 74 References / 75 4 Statistics in the Pharmaceutical Analysis Laboratory 77 Alvin J. Melveger 4.1. Errors Associated with Making Measurements / Systematic Error / 79
5 iii CONTENTS Random Error / Significant Figures and Rounding / Number of Significant Figures / Rounding / Some Definitions / Accuracy / Precision / Absolute Error / Relative Error / Mean / Average Deviation / Standard Deviation / Relative Standard Deviation / Comparison of Precision and Accuracy / Standard Error / Normal Distribution of Repeated Measurements / Student t Test / Applications of t Test / Propagation of Uncertainty (Errors) / Addition and Subtraction of Uncertainties / Multiplication or Division of Uncertainties / Rejection of Outliers / Linear Regression Analysis / Quality Assurance/Control / Conclusion / 102 References / Basic Analytical Operations and Solution Chemistry 105 Nicholas H. Snow and Wyatt R. Murphy, Jr Analytical Reagents / Sampling / Obtaining a Representative Sample / Preparing Samples for Analytical Methods / 107
6 CONTENTS ix Weighing and Balances / Volumetric Glassware / 110 5:2.5. Filtering / Chemical Equilibrium / Equilibrium Constants / Le Chatelier's Principle / Equilibrium as a Basis for Sample Pretreatment / Aqueous Solution Equilibria / 120 \ Introduction / Acids and Bases / Reduction-Oxidation Equilibria / Introduction / Karl Fischer Titration / Karl Fischer Reagents and Reactions / Karl Fischer Titration Procedures / Method Development Issues in Karl Fischer Titration / Other Methods for Determining Water / Loss on Drying / Instrumental Methods / Miscellaneous Techniques / Differential Scanning Calorimetry and Thermal Analysis / 145 References / Spectroscopy 149 Perlette Abuaf and Alvin J. Melveger 6.1. The Electromagnetic Spectrum / Wave-Particle Duality / Wave Parameters / Particle Parameters / Transitions and Energies / Ultraviolet/Visible Spectroscopy / Electron Type / 153
7 ( CONTENTS Chromophores / Conjugation and Spectral Shifts / Infrared Spectroscopy / Group Frequencies / Fingerprinting / Beers Law and Quantitative Analysis / Transmittance / Effect of Concentration on Transmittance / Effect of Path Length on Transmittance / Instrumentation / UV/VIS Instrumentation / IR Instrumentation / Raman Spectroscopy / Raman Instrumentation / Near-IR (NIR) Spectroscopy / Other Optical and Spectroscopic Techniques / Polarimetry / Inductively Coupled Plasma (ICP) and Atomic Absorption Spectroscopy (AAS) / Mass Spectroscopy (MS) / Nuclear Magnetic Resonance (NMR) Spectroscopy / Summary / 184 General References / Chromatographic Principles 185 James M. Miller 7.1. Definitions, Terms, and Symbols / Chromatography / The Chromatographic Process / Some Chromatographic Terms and Symbols / The Normal Distribution / Asymmetry and Tailing Factor / Plate Number / Comparison of GC and LC / 198
8 CONTENTS Xi 7.3. Two Important Fundamentals / Thermodynamics of Chromatography / 199 7:3.2. Kinetics / Some Additional Terms / Resolution / Retardation Factor / System Suitability / Summary / 215 References / Gas Chromatography 217 James M. Miller and Harold M. McNair 8.1. Some Historical Notes / Advantages and Disadvantages / Classification of GC / Columns / Stationary Phases / Column Materials / Comparison of Column Types / Solid Supports / Solid Stationary Phases (GSC) / Other Instrument Components / Carrier Gas / Flow Control and Measurement / Sample Inlets and Sampling Devices / Detectors / Temperature Considerations / Temperature Zones / Programmed Temperature GC (PTGC) / Optimization and Method Development / Column Selection / Optimization According to Basic Principles / Some Special Topics / Gas Chromatography/Mass Spectrometry (GC/MS) / 249
9 xii CONTENTS Derivatization / 250 Headspace Sampling USP / Applications / Analysis of Residual References / 252 / 250 Solvents / Liquid Chromatography: Basic Overview 255 Lee N. Polite 9.1. Introduction / Importance of HPLC in the Pharmaceutical Industry / Column Versus Planar Liquid Chromatography / Low-Pressure Versus High-Pressure Liquid Chromatography / Advantages and Disadvantages of HPLC / Isocratic Versus Gradient Elution / Column Methods / Normal Phase / Reversed Phase / Ion-Exchange Chromatography / Ion Chromatography (IC) / Ion Pair Chromatography (IPC) / Size Exclusion Chromatography (SEC) / Planar Methods: TLC and PC / Quick and Dirty Procedures / Automation and Special Equipment / High-Performance Thin-Layer Chromatography (HPTLC) / Advantages and Disadvantages of TLC / USP / Instrumentation for HPLC / Pumps / Sample Introduction Devices / Tubing and Connectors / 273
10 CONTENTS XiH Detectors / Troubleshooting / Capillary Electrophoresis (CE) / CE Systems / 280 References / 281 ) HPLC Column Parameters 283 Richard Hartwick Column Equivalency / Review of Chromatographic Parameters / Parameters Necessary for Equivalent Columns / Retentiveness and Selectivity / Peak Shape / Column Efficiency / Resolution / Reduced Plate Heights to Estimate Expected Column Efficiencies / Putting It All Together Selecting an Equivalent Column / Choosing Equivalent Columns: An Example / 303 References / 307 Dissolution 309 Ross Kirchhoefer and Rudy Peelers Introduction / History / Early Improvements in Dissolution Equipment / Dissolution Basics / Disintegration Tests / Elementary Theory / Practical Aspects / Dissolution Specifications / USP/NF Pharmacopeia General Chapter <711> / Apparatii / 315
11 XiV CONTENTS Parameters Affecting the Dissolution Test / 315 Test Equipment / 322 Stage Testing / 322 Calibrators / 323 Sampling / 323 Measurement of the Pharmaceutical Active / 326 Analyst Checklist / 328 References / Analytical Method Development for Assay and Impurity Determination in Drug Substances and Drug Products 331 Jonathan B. Crowther, Paul Salomons, and Cindi Callaghan Background / Introduction / Specifications and Their Influence on Method Development / International Guidelines and Their Influence on Method Development / The Method Development Life Cycle Overview / Planning / Review Company Policy on Method Development/Validation /, Defining the Objectives/Requirements of the Method / Illustration of Method Requirements / Information Gathering / Resource Gathering: Resources/ Instrumentation/Materials and Standards / Documentation: Development Plan / Method Development General Considerations / Initial Method Development / Method Optimization / Method Prevalidation Evaluation / Robustness / System Suitability / 350
12 CONTENTS XV Documentation / Method Development Report / Completing Method Development / Method Development Experimental Considerations / Introduction / General Components of HPLC Method Development / Obtaining Sufficient Resolution Considering Method Requirements / Validation Activities / Documentation Protocol / Method Validation Experimental / Documentation Report / Analytical Method Transfer / Documentation Protocol / Method Transfer Experimental / Documentation Transfer Report / Periodic Review / Reference Standards and Samples to Support Stability Indicating Method Development / Types of Standards / Handling of Standards / Summary / 368 References / Some Principles of Quantitative Analysis 371 James M. Miller Detector Classifications (Chromatographic) / Concentration Versus Mass Flow Rate / Bulk Property Versus Solute Property / Selective Versus Universal / Detector Characteristics / Noise / Time Constant / Cell Volume / Signal / 381
13 XVi CONTENTS Methods of Quantitative Analysis / 385 Standards and Calibration / 385 External Standard / 387 Area Normalization / 388 Area Normalization with Response Factors / 388 Internal Standard Method / 389 Standard Addition Method / 390 Summary / 391 Additional Topics / Trace Analysis / The High-Low Method for HPLC / 392 References / Laboratory Data Systems 395 R. D. McDowall Introduction / Data and Information Management / Purpose of Data Systems / Types of Data System / Laboratory Information Management Systems (LIMS) / A LIMS Has Two Targets / Benefits of a LIMS / 39? ' Regulatory Issues / Chromatography Data Systems / Analog-to-Digital (A/D) Conversion / Rationale for A/D Conversion / Principles of A/D Conversion / Peak Detection / CDS Workflow / Sequence of Data System Operation / Instrument Control / Interfacing CDS to Laboratory Information Management Systems / Concluding Remarks / 420 References / 420
14 CONTENTS XVil 15 Qualification of Laboratory Instrumentation, Validation, and Transfer of Analytical Methods 423 Jonathan B. Crowther, M. Ilias Jimidar, Nico Niemeijer, and Paul Salomons Introduction / Instrument Qualification / Instrumentation Life Cycle / Introduction Qualification Versus Calibration / Prospective Versus Retrospective / Instrument Qualification Process Assembly of the Qualification Team / The Qualification Protocol / IQ Protocol / Installation Qualification / Operational Qualification / Performance Qualification / Ongoing Monitoring / Final Qualification Report / Instrument Qualification Summary / Analytical Method Validation / Introduction to Method Validation / Determining the Characteristics of the Validation / Definitions / Method Validation Documentation / A Systematic Approach to Validation Experimentation / Determination of Method Specificity / Demonstration of Linearity and Range; Determination of Relative Response Factor / Determination of Detection and Quantitation Limit / Demonstration of Accuracy of the Method / Determination of Method Precision / Target Acceptance Criteria / Final Method Minor Method Refinement / 451
15 xviii CONTENTS Validation Summary / Method Transfer / Transfer Documentation / Method Transfer Protocol / Method Transfer Experimental / Transfer Summary and Approval / Chapter Summary / 456 References / 457 APPENDIXES I LIST OF SYMBOLS AND ACRONYMS 459 II GLOSSARY OF TERMS USED IN ICH DOCUMENTS 467 III UNIVERSAL TESTS, DOSAGE-FORM-SPECIFIC TESTS, AND ACCEPTANCE CRITERIA 473 IV USP CHROMATOGRAPHIC PHASES 477 INDEX - 483
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