Bioequivalence and Bioavailability Forum

Dear Avinash,

» For each individual matrix sources/lots evaluated, the accuracy should be within ±15% of the nominal concentration and the precision (per cent coefficient of variation (%CV)) should not be greater than 15%”
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» To comply with M10 guideline, for checking accuracy is it necessary to have calibration standards in matrix factor experiment?

Well, how else could you check accuracy ? But of course: the blank matrix used to prepare calibration samples should not be one of the matrices tested for matrix effects, otherwise this would bias the experiment (you'd be sure that at least this one would pass).

» Matrix factor, Our practice is to compare post extracted spiked sample vs aqueous sample, acceptance criteria is CV for matrix factor and IS normalised matrix factor should be ≤ 15%

Yes, that's what was in the EMA guideline, based on the recommendations of the Crystal City III conference in 2006. Recommendations in M10 are now different and you'll have to update your SOP and change your practice.