When are specificity and precision required?
Specificity and precision should be performed with every biorelevant medium tested (for example if study requires two media the studies should be performed with both). This is because each biorelevant medium is different and possesses different characteristics in terms of lipophilicity, structures and particle size. Furthermore, specificity and precision should be performed if a different brand of column and/or HPLC are used for analysis.
Specificity and precision can be examined together in the same sequence by injecting and analysing multiple sets of sample solutions (e.g. biorelevant medium, drug without biorelevant medium, drug with biorelevant medium and dosage form (e.g. drug and excipients) with biorelevant medium).