Analytical Method Development and Validation: Swartz, Michael: 9780824701154: Book: : eCampus.com

This concise guide delineates specific approaches to the successful development, optimization, and high-quality HPLC-based analytical methods and shows how these steps can be integrated into a formal process reflecting present United States Pharmocopeia regulations. Paper.

Preface

(8)

Tables and Figures

(2)

Abbreviations

(4)

1. Introduction

(8)

1.1 The Validation Process

(1)

1.2 Qualification

(4)

1.2.1 Installation Qualification (IQ)

(1)

1.2.2 Operational Qualification (OQ)

(1)

1.2.3 Performance Qualification (PQ)

(2)

2. Method Development, Optimization, and Validation Approaches

(28)

2.1. Method Development

(4)

2.2. Optimization

(1)

2.3. Method Validation Approaches

(10)

2.3.1. The Zero-Blind Method

(1)

2.3.2. The Single-Blind Method

(1)

2.3.3. The Double-Blind Method

(1)

2.3.4. The Analysis of Standard Reference Materials

(1)

2.3.5. The Interlaboratory Collaborative Study

(1)

2.3.6. Comparisons with a Currently Accepted Method

(1)

2.4. Step-by-Step HPLC Method Development, Optimization, and Validation: An Outline

(14)

3. Method Validation (USP/ICH)

(20)

3.1. Terminology and Definitions

(15)

3.1.1. Accuracy

(1)

3.1.2. Precision

(3)

3.1.3. Specificity

(1)

3.1.4. Limit of Detection

(1)

3.1.5. Limit of Quantitation

(3)

3.1.6. Linearity and Range

(2)

3.1.7. Ruggedness

(1)

3.1.8. Robustness

(1)

3.2. Data Elements Required for Assay Validation

(5)

4. System Suitability

(2)

5. Method Validation Protocol

(6)

6. Method Transfer and Revalidation

(2)

7. Summary and Conclusions

(2)

Bibliography


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