Analytical methods include identification test, quantitative test for impurities,limit test for impurities, assay and dissolution test. This guide on analyticalmethod validation presents the characteristics for consideration during thevalidation of an analytical procedure.
PRE-VALIDATION/ VERIFICATION REQUIREMENTS.
Chemicals, such as reagents and standards, should be available in sufficient quantities, accurately identified, sufficiently stable and checked for purity. Other materials and consumables, for example, chromatographic columns, should be qualified to meet the column’s performance criteria. Validation on the analytical procedure should be performed with homogeneous samples, and validation data should be obtained by repeatedly analyzing aliquots of a homogeneous sample, each of which has been independently prepared according to the analytical method procedure.