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level: Level 2

Questions and Answers List

level questions: Level 2

Question	Answer
ANALYTICAL PROCEDURE CHARACTERISTICS	1 SPECIFICITY 2 LINEARITY 3 RANGE 4 ACCURACY 5 PRECISION 6 DETECTION LIMIT 7 QUANTITATION LIMIT 8 ROBUSTNESS 9 SYSTEM SUITABILITY TESTING
An investigation of __ should be conducted during the validation of identification tests, the determination of impurities and the assay.	SPECIFICITY
The __ of a procedure may be confirmed by obtaining positive results (perhaps by comparison with a known reference material) from samples containing the analyte, coupled with negative results from samples which do not contain the analyte. may be applied to materials structurally similar to or closely related to the analyte to confirm that a positive response is not obtained	Discrimination
For chromatographic procedures, representative __ should be used to demonstrate specificity and individual components should be appropriately labelled. Similar considerations should be given to other separation techniques.	Chromatograms
this can be done by spiking pure substances (drug substance or drug product) with appropriate levels of impurities and/or excipients and demonstrating that the assay result is unaffected by the presence of these materials (by comparison with the assay result obtained on unspiked samples).	Impurities are available - demonstration of the discrimination of the analyte in the presence of impurities
specificity may be demonstrated by comparing the test results of samples containing impurities or degradation products to a second wellcharacterized procedure	Impurities are not available
demonstrated directly on the drug substance (by dilution of a standard stock solution) and/or separate weighings of synthetic mixtures of the drug product components, using the proposed procedure. should be evaluated by visual inspection of a plot of signals as a function of analyte concentration or content. The correlation coefficient, y-intercept, slope of the regression line and residual sum of squares should be submitted.	LINEARITY
normally derived from linearity studies Established by confirming that the analytical procedure provides an acceptable degree of linearity, accuracy and precision when applied to samples containing amounts of analyte within or at the extremes of the specified range of the analytical procedure.	RANGE
should be established across the specified range of the analytical procedure	ACCURACY
Accuracy should be assessed using a minimum of __ over a minimum of __ covering the specified range	9 determinations, 3 concentration levels
Repeatability should be assessed using:	A) a minimum of 9 DETERMINATIONS covering the specified range for the procedure OR B) a minimum of 6 DETERMINATIONS at 100% of the test concentration.
The extent to which __ should be established depends on the circumstances under which the procedure is intended to be used.	intermediate precision
is assessed by means of an inter-laboratory trial.	Reproducibility
DETECTION LIMIT approaches:	1 Based on Visual Evaluation 2 Based on Signal-to-Noise
may be used for non-instrumental methods	Based on Visual Evaluation
performed by comparing measured signals from samples with known low concentrations of analyte with those of blank samples and establishing the minimum concentration at which the analyte can be reliably detected	Based on Signal-to-Noise
should be considered during the development phase and depends on the type of procedure under study	ROBUSTNESS