Transcription of Guidelines for the validation of analytical methods
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Guidelines for the validation of analytical methods
Guidelines FOR THE validation OF analytical methods FOR ACTIVE CONSTITUENT, AGRICULTURAL AND VETERINARY CHEMICAL PRODUCTS October 2004 APVMA PO Box E240 KINGSTON 2604 AUSTRALIA : +61 2 6272 5852 Table of Contents Introduction_____3 Scope_____3 Data Requirements_____3 Parameters for Method Validation_____3 Selectivity (Specificity)_____3 Linearity_____4 Range_____4 Accuracy_____4 Precision_____5 Limit of Detection (LOD)_____6 Limit of Quantitation (LOQ)_____6 validation Characteristics and Requirements_____6 General Notes_____6 Regulatory analytical Methods_____6 Alternative analytical Methods_____7 Typical Characteristics for Nuclear Magnetic Resonance (NMR) Data_____7 analytical Reference Standards_____7 Good Laboratory Practice_____7 Revalidation_____7 Definitions and Abbreviations_____8 References_____8 2 INTRODUCTION In order to generate the Part 2 Chemistry and Manufacture data for the approval of active constituents and registration of agricultural and veterinary chemical products, robust, accurate a
In the standard addition method, a sample is assayed, a known amount of pure active constituent is added, and the sample is again assayed. The difference between the results of the two assays is compared with the expected answer. In both methods (spiked – placebo recovery and standard addition method), recovery is defined as
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