CONTENTS
1.0 Introduction
1.1 Definitions
1.1.1 Validation
1.1.2 Method of analysis
1.1.3 Performance characteristics of a method of analysis
2.0 Single-Laboratory Validation Work
2.1 Preparation of the Laboratory Sample
2.2 Identification
2.3 Method of Analysis or Protocol
2.3.1 Optimization
2.3.2 Reference standard
2.3.3 Ruggedness Trial
2.3.4 Specific variables
a. Analyte addition
b. Reextraction of the extracted residue
c. Comparison with different solvents
d. Comparison with results from a different procedure
e. System Suitability Checks
3. Performance Characteristics
3.1 Applicability
3.2 Selectivity
3.3 Calibration
3.3.1 External Standard Method
3.3.2 Internal Standard Method
3.3.3 Standard Addition Method
3.4 Reliability Characteristics
3.4.1 Accuracy
3.4.2 Repeatability Precision (sr, RSDr)
3.4.3 Measurement Uncertainty
3.4.4 Reproducibility Precision (sR, RSDR)
3.4.5 Limit of Determination
3.4.6 Reporting low-level values
3.4.7 Dichotomous reporting
3.5 Controls
3.5.1 Control charts
3.5.2 Injection controls