acceptance of blank sample in analytical run [Bioanalytics]

posted by Ladi – Thailand, 2022-11-08 04:07 (90 d 00:26 ago) – Posting: # 23357
Views: 1,015

Dear forum members,

What should be the acceptance criteria for the blank and zero samples that we inject before calibration curve standards in analytical run?

According to the ICH M10 guideline on bioanalytical method validation, section 3.3.1 Analytical run, states that "An analytical run consists of a blank sample (processed matrix sample without analyte and without IS), a zero sample (processed matrix with IS)".

However, I couldn't find the acceptance criteria for the blank and zero sample in the guideline.

Our current SOP is to the accept the analytical run if interference at RT of analyte in blanK and zero sample is less than 20% compare to LLOQ and if interference at RT of IS is less than 5% compare to IS response in LLOQ (basically follow Selectivity criteria).

I have seen many cases where some runs are rejected because the blank sample is contaminated from sample preparation error (zero sample and pre-dose samples are clean).

I personally don't think it make sense to reject a whole run from one contaminated sample!

Any suggestion or guidelines, papers I can use to use as reference to modify our SOP?

Thank you for any suggestion or comment,

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