Bioequivalence and Bioavailability Forum

Dear Members

This is with regard to ICH M10 guideline

For Matrix effect, it is mentioned as “should be evaluated by analysing at least 3 replicates of low and high QCs, each prepared using matrix from at least 6 different sources/lots. 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%”

To comply with M10 guideline, for checking accuracy is it necessary to have calibration standards in matrix factor experiment?

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%

Please opine.

Thanks & regards,
Avinash

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Edit: category changed [Ohlbe]