Specificity is one of the method validation parameter. Specificity defined by ICH Q2(R1), is as below, “Specificity is the ability to assess unequivocally the analyte in the presence of components which may be expected to be present.” So in the context of specificity, the interested component must get explicitly assessed in presence of other sample components. To explain it further, let us take an example of a finished product such as tablets. Test solution of tablets consists of interested compounds (such as API and impurities) as well as the components which are of no interest (such as excipients). The excipients, though they are of no interest, one can’t completely remove them from test solution and hence it is important to assess their impact on quantification of analyte. Also, in case of assay analysis, the impurities will become the components of no interest and one must assess impurity interference while performing specificity. Let us understand how specificity is co...
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